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  "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-1245-2025.jsonld",
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  "name": "Medtronic Pipeline Vantage Embolization Device with Shield Technology, REF: PED3-027-350-12, PED3-027-350-14, PED3-027-350-16, PED3-027-350-20, PED3-027-350-25, PED3-027-400-12, PED3-027-400-14, PED3-027-400-16, PED3-027-400-18, PED3-027-400-20, PED3-027-400-25, PED3-027-400-30, PED3-027-450-12, PED3-027-450-14, PED3-027-450-16, PED3-027-450-18, PED3-027-450-20, PED3-027-450-25, PED3-027-450-30, PED3-027-450-40, PED3-027-500-14, PED3-027-500-16, PED3-027-500-18, PED3-027-500-20, PED3-027-500-25, PED3-027-500-30, PED3-027-500-40, PED3-027-550-16, PED3-027-550-18, PED3-027-550-20, PED3-027-550-30, PED3-027-550-40, PED3-027-550-50, PED3-027-600-16, PED3-027-600-18, PED3-027-600-20, PED3-027-600-30, PED3-027-600-40, PED3-027-600-50",
  "description": "FDA recall Z-1245-2025 — Micro Therapeutics,  Inc. is recalling Medtronic Pipeline Vantage Embolization Device with Shield Technology, REF: PED3-027-350-12, PED3-027-350-14, PED3-027-350-16, PED3-027-350-20, PED3-027-350-25, PED3-027-400-12, PED3-027-400-14, PED3-027-400-16, PED3-027-400-18, PED3-027-400-20, PED3-027-400-25, PED3-027-400-30, PED3-027-450-12, PED3-027-450-14, PED3-027-450-16, PED3-027-450-18, PED3-027-450-20, PED3-027-450-25, PED3-027-450-30, PED3-027-450-40, PED3-027-500-14, PED3-027-500-16, PED3-027-500-18, PED3-027-500-20, PED3-027-500-25, PED3-027-500-30, PED3-027-500-40, PED3-027-550-16, PED3-027-550-18, PED3-027-550-20, PED3-027-550-30, PED3-027-550-40, PED3-027-550-50, PED3-027-600-16, PED3-027-600-18, PED3-027-600-20, PED3-027-600-30, PED3-027-600-40, PED3-027-600-50 (Devices, Class I). The enforcement record is RECORDED; the classification is a DETERMINATION (FDA's regulatory verdict); the boundary is INTERPRETATION (a recall ≠ harm to a specific person). Source: openFDA. CC0.",
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  "dateModified": "2026-06-24T07:02:03.626072+00:00",
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  "about": {
    "@type": "schema:MedicalDevice",
    "name": "Medtronic Pipeline Vantage Embolization Device with Shield Technology, REF: PED3-027-350-12, PED3-027-350-14, PED3-027-350-16, PED3-027-350-20, PED3-027-350-25, PED3-027-400-12, PED3-027-400-14, PED3-027-400-16, PED3-027-400-18, PED3-027-400-20, PED3-027-400-25, PED3-027-400-30, PED3-027-450-12, PED3-027-450-14, PED3-027-450-16, PED3-027-450-18, PED3-027-450-20, PED3-027-450-25, PED3-027-450-30, PED3-027-450-40, PED3-027-500-14, PED3-027-500-16, PED3-027-500-18, PED3-027-500-20, PED3-027-500-25, PED3-027-500-30, PED3-027-500-40, PED3-027-550-16, PED3-027-550-18, PED3-027-550-20, PED3-027-550-30, PED3-027-550-40, PED3-027-550-50, PED3-027-600-16, PED3-027-600-18, PED3-027-600-20, PED3-027-600-30, PED3-027-600-40, PED3-027-600-50",
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      "name": "Micro Therapeutics,  Inc."
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  "claims": [
    {
      "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-1245-2025/enforcement-record",
      "@type": "schema:Claim",
      "name": "FDA recall Z-1245-2025: Micro Therapeutics,  Inc. is recalling Medtronic Pipeline Vantage Embolization Device with Shield Technology, REF: PED3-027-350-12, PED3-027-350-14, PED3-027-350-16, PED3-027-350-20, PED3-027-350-25, PED3-027-400-12, PED3-027-400-14, PED3-027-400-16, PED3-027-400-18, PED3-027-400-20, PED3-027-400-25, PED3-027-400-30, PED3-027-450-12, PED3-027-450-14, PED3-027-450-16, PED3-027-450-18, PED3-027-450-20, PED3-027-450-25, PED3-027-450-30, PED3-027-450-40, PED3-027-500-14, PED3-027-500-16, PED3-027-500-18, PED3-027-500-20, PED3-027-500-25, PED3-027-500-30, PED3-027-500-40, PED3-027-550-16, PED3-027-550-18, PED3-027-550-20, PED3-027-550-30, PED3-027-550-40, PED3-027-550-50, PED3-027-600-16, PED3-027-600-18, PED3-027-600-20, PED3-027-600-30, PED3-027-600-40, PED3-027-600-50",
      "text": "The FDA logged enforcement record Z-1245-2025: Micro Therapeutics,  Inc. is voluntarily recalling Medtronic Pipeline Vantage Embolization Device with Shield Technology, REF: PED3-027-350-12, PED3-027-350-14, PED3-027-350-16, PED3-027-350-20, PED3-027-350-25, PED3-027-400-12, PED3-027-400-14, PED3-027-400-16, PED3-027-400-18, PED3-027-400-20, PED3-027-400-25, PED3-027-400-30, PED3-027-450-12, PED3-027-450-14, PED3-027-450-16, PED3-027-450-18, PED3-027-450-20, PED3-027-450-25, PED3-027-450-30, PED3-027-450-40, PED3-027-500-14, PED3-027-500-16, PED3-027-500-18, PED3-027-500-20, PED3-027-500-25, PED3-027-500-30, PED3-027-500-40, PED3-027-550-16, PED3-027-550-18, PED3-027-550-20, PED3-027-550-30, PED3-027-550-40, PED3-027-550-50, PED3-027-600-16, PED3-027-600-18, PED3-027-600-20, PED3-027-600-30, PED3-027-600-40, PED3-027-600-50 — reason: Use of embolization device with diameters greater-than-or-equal-to 4mm may lead to incomplete wall apposition and/or braid deformation (fish-mouthing/braid narrowing/braid collapse) noted during procedure and post-procedure, typically noted at 6-12 month imaging follow-up, potentially can lead to thrombosis and/or serious adverse events. Higher risk in females less-than-or-equal-to 45 years of age. Status: Ongoing — the recall is still being carried out.. Initiated 2025-01-30. Affected lots/codes: All unused devices. Product lots including and between B317266 and B817292.  REF/UDI-DI/Lot: PED3-027-350-12/00847536035263, 00847536030770/B409106, B637287, B700548;  PED3-027-350-14/00847536035287, 00847536030787/B409234, B700550, B794880;  PED3-027-350-16/00847536035294, 00847536030794/B409692, B697962, B700551, B795136, B795142, B809808;  PED3-027-350-20/00847536035317, 00847536030817/B410645, B558444, B623124, B672921, B700552, B777630;  PED3-027-350-25/00847536035324, 00847536030824/B410718, B672530, B700553, B771934, B771938;  PED3-027-400-12/00847536030862, 00847536035362, 00847536036680/B321585, B336094, B349668,B371137, B409814, B414591, B437740, B482271, B594119, B597085, B598465, B612514, B616043, B616052, B647374, B649853, B655648, B658620, B658685, B666385, B666418, B671805, B720634, B720635, B744619, B744621, B756639, B765446, B765448, B780611, B786108;  PED3-027-400-14/00847536030879, 00847536035379, 00847536036697/B318079, B335275, B339540, B350391, B364366, B372416, B375523, B410879, B415080, B422400, B438538, B448437, B459694, B460349, B464650, B469525, B474550, B556978, B601007, B608852, B616050, B622657, B625452, B625453, B629552, B683800, B689019, B691414, B698756, B714840, B715051, B721683, B745065, B753732, B763635, B763642, B802419;  PED3-027-400-16/00847536030886, 00847536035386, 00847536036703/B326193, B330879, B330881, B357080, B401867, B402034, B403012, B417737, B419736, B420127, B422990, B423257, B426548, B438677, B439156, B439301, B445198, B449040, B449149, B449591, B453559, B454843, B459846, B460523, B465307, B469682, B474417, B560503, B575892, B578340, B597083, B603196, B608221, B611268, B615571, B623135, B623136, B625944, B625945, B672865, B678987, B694225, B694934, B699098, B715043, B721778, B721782, B730828, B730829, B738422, B738423, B739914, B744842, B744860, B766155, B766701, B769315, B776922, B776933, B777378, B791207;  PED3-027-400-18/00847536036710/B795091;  PED3-027-400-20/00847536030909, 00847536035409, 00847536036727/B318459, B329314, B329316, B338468, B368540, B374265, B380481, B381434, B383600, B384092, B384233, B388982, B391816, B420182, B420318, B423735, B439714, B441852, B449699, B450256, B460915, B461092, B461510, B465420, B470193, B475106, B478030, B485264, B487677, B557537, B565556, B571634, B575122, B576711, B577356, B578341, B631830, B632949, B635238, B636674, B649884, B654937, B657799, B658273, B658540, B659188, B659211, B666546, B671140, B679007, B680109, B692381, B692536, B692916, B693469, B705994, B722574, B722592, B730946, B739972, B741664, B741666, B746709, B752946, B753532, B756807, B756808, B763701, B778174, B778192, B778193, B778534, B778535, B781327, B781347, B791327, B811796;  PED3-027-400-25/00847536030916, 00847536035416, 00847536036734/B322422, B394134, B400793, B411501, B415161, B424676, B432804, B442338, B470284, B474964, B481516, B483308, B568647, B576712, B577358, B634985, B636192, B648012, B649383, B661189, B675951, B689989, B704525, B706229, B706230, B709931, B712123, B726423, B741049, B741051, B747537, B747541, B754030, B765519, B776777, B777166, B780003, B780520, B786557;  PED3-027-400-30/00847536030923, 00847536035423, 00847536036741/B394830, B401265, B413855, B415343, B415743, B444760, B470728, B475566, B484529, B594121, B603201, B608917, B616555, B622661, B623126, B637143, B675952, B681380, B681596, B711437, B711438, B723555, B731515, B731516, B741809, B764098, B778206, B778207, B798796;  PED3-027-450-12/00847536030961, 00847536035461, 00847536036789/B322748, B456666, B471328, B486866, B575963, B601277, B637185, B666423, B703226, B706228, B708791, B711095, B750794, B751129, B758665, B758666, B758667, B794235;  PED3-027-450-14/00847536030978, 00847536035478, 00847536036796/B320465, B336565, B340244, B351032, B374880, B404541, B425289, B432042, B462206, B470900, B477408, B481700, B483148, B601181, B604476, B617556, B637191, B669563, B669568, B675953, B692841, B694794, B696125, B697448, B704465, B709288, B711828, B719080, B719084, B741791, B745142, B745143, B751967, B753463, B772618, B814124;  PED3-027-450-16/00847536030985, 00847536035485, 00847536036802/B318562, B331383, B331528, B340320, B351038, B374958, B384705, B385273, B395007, B405061, B407737, B424599, B450972, B465971, B471455, B483899, B485855, B535234, B552285, B568744, B571592, B585330, B596585, B622035, B625593, B626044, B628700, B629503, B643420, B659204, B659718, B660616, B661809, B666550, B666589, B668758, B669369, B675954, B682011, B698182, B723071, B723072, B723787, B723791, B735828, B735829, B735830, B746751, B746752, B753483, B757640, B757645, B762226, B762228, B764394, B787789, B789383, B803301;   PED3-027-450-18/00847536036819/B797308;  PED3-027-450-20/00847536031005, 00847536035508, 00847536036826/B325710, B328706, B328709, B355336, B357077, B357672, B377120, B381729, B389289, B390355, B397986, B419639, B421094, B423116, B425691, B440190, B440356, B440859, B442521, B449796, B450384, B451092, B452205, B461652, B462339, B464094, B480010, B481041, B487030, B549631, B550980, B557508, B569276, B573461, B574475, B584490, B585331, B594727, B632801, B635651, B650035, B651312, B651584, B652220, B669427, B673379, B674005, B681938, B696501, B696960, B700714, B700961, B703735, B705508, B728234, B729519, B732220, B752592, B758912, B758914, B760821, B774880, B776153, B794615, B794620, B798765, B810476, B811668;  PED3-027-450-25/00847536031012, 00847536035515, 00847536036833/B319170, B352790, B370633, B395978, B403146, B408241, B419571, B425960, B443719, B453438, B453676, B463202, B467023, B471895, B472002, B488714, B558531, B590206, B596591, B597131, B600999, B604474, B604478, B611115, B613070, B616042, B645444, B645874, B646698, B652027, B654357, B681223, B681901, B693373, B696977, B697584, B699639, B699762, B730899, B751210, B751305, B752452, B759553, B759554, B775532, B800797;  PED3-027-450-30/00847536031029, 00847536035522, 00847536036840/B396144, B404416, B411353, B434096, B436536, B535757, B561797, B574352, B616037, B644866, B645276, B651451, B652656, B654460, B658656, B659930, B675955, B688941, B713232, B714797, B714798, B717097, B730298, B731601, B731603, B784372, B785363, B810615, B815818;  PED3-027-450-40/00847536031043, 00847536035546, 00847536036864/B353358, B377744, B411399, B448343, B549634, B559739, B615408, B623125, B637017, B675956, B683288, B684783, B699735, B699776, B704439, B710043, B710051, B733018, B761384, B761385, B761386, B764292, B778738, B778836, B786518;  PED3-027-500-14/00847536031067, 00847536035577, 00847536036895/B353371, B411952, B425824, B432210, B447358, B455035, B455951, B601160, B603379, B606137, B624428, B637037, B651443, B674478, B675957, B685652, B701387, B706116, B706164, B710564, B710571, B711705, B729531, B764751, B765289, B785958, B790520;  PED3-027-500-16/00847536031074, 00847536035584, 00847536036901/B320910, B353996, B375682, B425116, B426932, B432683, B441009, B479353, B536475, B558194, B568648, B622122, B622123, B638485, B638487, B644714, B645376, B647467, B649263, B652167, B652663, B654363, B655727, B683524, B703758, B704315, B704999, B710455, B729572, B730327, B785458, B785792, B785793, B807437, B809811;  PED3-027-500-18/00847536036918/B797650;  PED3-027-500-20/00847536031098, 00847536035607, 00847536036925/B326325, B331608, B341953, B354635, B370450, B377872, B381636, B386124, B396652, B416028, B426418, B443827, B456058, B457830, B466125, B472700, B476324, B479966, B485115, B566387, B590194, B596594, B603380, B645491, B645898, B645962, B647222, B650050, B651347, B677890, B678397, B678959, B679068, B684999, B695686, B705596, B705610, B707567, B707606, B717655, B727541, B734039, B737927, B737928, B752681, B763087, B772659, B773371, B773372, B779449, B779450, B779633;  PED3-027-500-25/00847536031104, 00847536035614, 00847536036932/B354639, B382191, B387287, B396748, B413971, B417560, B472568, B478679, B536229, B570707, B603199, B646445, B648039, B680655, B688975, B689445, B693010, B694374, B695076, B700554, B702913, B720212, B720213, B720231, B747329, B747330, B747332, B751359, B761968, B763427, B800923;  PED3-027-500-30/00847536031111, 00847536035621, 00847536036949/B337320, B342643, B358320, B378426, B382386, B382844, B401379, B427074, B428049, B428522, B429875, B435865, B436340, B445405, B452880, B456544, B596584, B598708, B606136, B623128, B655004, B655034, B655744, B663561, B666422, B668512, B669368, B669370, B707244, B728433, B743037, B743038, B743039, B750658, B751192, B752314, B752315, B779538;  PED3-027-500-40/00847536031135, 00847536035645, 00847536036963/B319346, B340946, B373012, B373062, B374156, B379194, B397871, B398496, B456742, B457215, B464764, B467126, B473757, B482175, B567777, B573469, B585305, B590192, B677757, B682747, B693594, B701050, B703777, B703949, B707108, B710395, B711021, B711022, B736159, B747948, B749861, B753183, B753184, B762889, B773500;  PED3-027-550-16/00847536031166, 00847536035683, 00847536037007/B358321, B369526, B452971, B497779, B575962, B580922, B622743, B623127, B686266, B689577, B707045, B707126, B708154, B708159, B720912, B720913, B739371, B749920, B782490, B806751;  PED3-027-550-18/00847536037014/B803199;  PED3-027-550-20/00847536035706, 00847536031180, 00847536037021/B412256, B417797, B446018, B454303, B496490, B560727, B565445, B578965, B615897, B623137, B623138, B690738, B691319, B692483, B695336, B713205, B713214, B717726, B731786, B731789, B740657, B741946, B764254, B764286, B766393, B766406, B780554, B781697, B800693, B808083;  PED3-027-550-30/00847536031203, 00847536035720, 00847536037045/B397247, B408458, B414706, B416571, B473971, B475784, B479273, B494116, B608410, B611882, B615380, B663584, B666410, B695406, B696119, B697734, B709920, B713734, B713735, B729710, B738501, B738502, B746449, B783057, B783239, B783566;  PED3-027-550-40/00847536031227, 00847536035744, 00847536037069/B358931, B378536, B389916, B409027, B433336, B437033, B454059, B493075, B494673, B612534, B615604, B616547, B652056, B654234, B655595, B671064, B672455, B672476, B684986, B704973, B706035, B707059, B717259, B717261, B742095, B750469, B761584, B768849, B771892, B771893, B773963, B778320, B778326, B780176;  PED3-027-550-50/00847536031241, 00847536035768, 00847536037083/B397414, B412119, B431531, B435644, B437187, B616028, B637697, B658014, B705133, B717320, B717336, B717341, B724924, B745389, B745405, B745974, B749926, B785200, B785874;  PED3-027-600-16/00847536031289, 00847536035805, 00847536037120/B368960, B454127, B603197, B607478, B611280, B611281, B690544, B691908, B693533, B709546, B720780, B732968, B762785, B801322;  PED3-027-600-18/00847536037137/B801452;  PED3-027-600-20/00847536031302, 00847536035829, 00847536037144/B317266, B338536, B376423, B412355, B446526, B491096, B596581, B608223, B624427, B624430, B681791, B682681, B698133, B701028, B708016, B708642, B709539, B713242, B720316, B720318, B747892, B747893, B761449, B769429, B805791;  PED3-027-600-30/00847536031326, 00847536035843, 00847536037168/B339559, B412787, B457289, B467222, B489389, B594600, B597081, B611169, B611170, B626128, B652141, B653242, B654415, B681946, B682043, B701346, B711916, B712145, B719705, B726352, B726417, B728348, B735171, B748081, B748545, B748565, B758585, B808813;  PED3-027-600-40/00847536031340, 00847536035867, 00847536037182/B320318, B337325, B360226, B369513, B379020, B419419, B480964, B485981, B485982, B549767, B552409, B559740, B567778, B608855, B618581, B622005, B655601, B655798, B669603, B694091, B695569, B699270, B711618, B716111, B720752, B721600, B742928, B745966, B758046, B758050, B760363, B767594, B790633, B800873;  PED3-027-600-50/00847536031364, 00847536035881, 00847536037205/B327190, B332681, B342121, B403885, B415948, B428706, B429330, B433507, B434230, B457419, B557587, B617560, B623582, B626133, B651590, B652749, B653261, B653391, B658476, B658484, B670055, B670398, B673424, B680095, B695531, B703875, B713824, B714234, B726282, B732261, B732262, B732459, B733700, B746625, B758339, B758371, B768841, B783879, B783888, B788852, B790033, B794845. A RECORDED FDA enforcement action (occurred=true).",
      "claimType": "official_fact",
      "reviewStatus": "current",
      "commercialInfluence": false,
      "epistemicStatus": {
        "occurred": true,
        "supported": true,
        "adjudged": true,
        "operative": true
      },
      "grounding": {
        "groundingType": "SourceCitation",
        "source": "openFDA drug & device enforcement (recall) reports — U.S. FDA",
        "sourceUrl": "https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?action=select&recall_number=Z-1245-2025&lang=eng",
        "value": "Devices recall, status Ongoing",
        "adjudicator": {
          "name": "openFDA drug & device enforcement (recall) reports — U.S. FDA",
          "url": "https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?action=select&recall_number=Z-1245-2025&lang=eng"
        }
      },
      "falsifier": "A RECORD of measured/reported events (occurred=true) from openFDA drug & device enforcement (recall) reports — U.S. FDA; superseded when openFDA drug & device enforcement (recall) reports — U.S. FDA publishes its next release."
    },
    {
      "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-1245-2025/fda-classification",
      "@type": "schema:Claim",
      "name": "FDA classified recall Z-1245-2025 as Class I",
      "text": "The FDA assigned this recall Class I: Class I — the FDA judged there is a reasonable probability that use of the product would cause serious harm or death.. This is the FDA's official risk classification — its regulatory DETERMINATION of the hazard category (a verdict constituted by the FDA's recognition, occurred=FALSE), adjudged=TRUE because the FDA issued it. It is NOT a measurement of harm to any specific person.",
      "claimType": "regulatory_determination",
      "reviewStatus": "current",
      "commercialInfluence": false,
      "epistemicStatus": {
        "occurred": false,
        "supported": true,
        "adjudged": true,
        "operative": true
      },
      "grounding": {
        "groundingType": "AdjudicativeAct",
        "source": "U.S. FDA recall classification (openFDA enforcement)",
        "sourceUrl": "https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?action=select&recall_number=Z-1245-2025&lang=eng",
        "value": "Class I",
        "adjudicator": {
          "name": "U.S. FDA recall classification (openFDA enforcement)",
          "url": "https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?action=select&recall_number=Z-1245-2025&lang=eng"
        }
      },
      "falsifier": "occurred=FALSE: a regulatory DETERMINATION (an authority's classification/judgment) has NO material truthmaker independent of recognition — it is constituted by U.S. FDA recall classification (openFDA enforcement)'s say-so (a Searle institutional fact), not measured. adjudged=TRUE because U.S. FDA recall classification (openFDA enforcement) (an external authority) issued it. Distinct from a recorded measurement (which has an independent truthmaker) and from a modeled figure (a computed quantity, not a verdict). Challengeable; superseded if the authority reclassifies."
    },
    {
      "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-1245-2025/boundary",
      "@type": "schema:Claim",
      "name": "What an FDA recall is — and is NOT",
      "text": "A recall is a RECORDED FDA enforcement action — the FDA logged that a firm is removing or correcting a product, classed by the FDA's risk judgment. It does NOT establish that any specific unit is affected or caused harm; causation is not established. This record informs and compares — it is NOT medical advice and does not tell anyone to start or stop a drug or device. For a medical decision, route to the FDA recall record and a licensed pharmacist or prescriber.",
      "claimType": "interpretation",
      "reviewStatus": "current",
      "commercialInfluence": false,
      "epistemicStatus": {
        "occurred": false,
        "supported": true,
        "adjudged": false,
        "operative": true
      },
      "grounding": {
        "groundingType": "Interpretation",
        "source": "Atlas Commons L5 boundary (enforcement-action ≠ harm causation)",
        "sourceUrl": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/",
        "value": "a recorded enforcement action, not proof of harm or causation; not medical advice",
        "adjudicator": null
      },
      "falsifier": "occurred=FALSE (a framing, not an event) and adjudged=FALSE (an in-house reading, not an authority's verdict) — the LOWEST-warrant claim here. A flat representation would render this identically to the official facts; the four-status does not."
    }
  ],
  "hasPart": [
    {
      "@type": "schema:ItemList",
      "name": "FDA recall details — Z-1245-2025",
      "numberOfItems": 9,
      "itemListElement": [
        {
          "@type": "schema:ListItem",
          "position": 1,
          "item": {
            "Field": "Recall number",
            "Value": "Z-1245-2025",
            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 2,
          "item": {
            "Field": "Product type",
            "Value": "Devices",
            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 3,
          "item": {
            "Field": "Classification",
            "Value": "Class I",
            "Status": "determination"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 4,
          "item": {
            "Field": "Status",
            "Value": "Ongoing — the recall is still being carried out.",
            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 5,
          "item": {
            "Field": "Recalling firm",
            "Value": "Micro Therapeutics,  Inc.",
            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 6,
          "item": {
            "Field": "Reason",
            "Value": "Use of embolization device with diameters greater-than-or-equal-to 4mm may lead to incomplete wall apposition and/or braid deformation (fish-mouthing/braid narrowing/braid collapse) noted during procedure and post-procedure, typically noted at 6-12 month imaging follow-up, potentially can lead to thrombosis and/or serious adverse events. Higher risk in females less-than-or-equal-to 45 years of age",
            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 7,
          "item": {
            "Field": "Initiated",
            "Value": "2025-01-30",
            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 8,
          "item": {
            "Field": "Lot/code info",
            "Value": "All unused devices. Product lots including and between B317266 and B817292.  REF/UDI-DI/Lot: PED3-027-350-12/00847536035263, 00847536030770/B409106, B637287, B700548;  PED3-027-350-14/00847536035287, 00847536030787/B409234, B700550, B794880;  PED3-027-350-16/00847536035294, 00847536030794/B409692, B697962, B700551, B795136, B795142, B809808;  PED3-027-350-20/00847536035317, 00847536030817/B410645, B558444, B623124, B672921, B700552, B777630;  PED3-027-350-25/00847536035324, 00847536030824/B410718, B672530, B700553, B771934, B771938;  PED3-027-400-12/00847536030862, 00847536035362, 00847536036680/B321585, B336094, B349668,B371137, B409814, B414591, B437740, B482271, B594119, B597085, B598465, B612514, B616043, B616052, B647374, B649853, B655648, B658620, B658685, B666385, B666418, B671805, B720634, B720635, B744619, B744621, B756639, B765446, B765448, B780611, B786108;  PED3-027-400-14/00847536030879, 00847536035379, 00847536036697/B318079, B335275, B339540, B350391, B364366, B372416, B375523, B410879, B415080, B422400, B438538, B448437, B459694, B460349, B464650, B469525, B474550, B556978, B601007, B608852, B616050, B622657, B625452, B625453, B629552, B683800, B689019, B691414, B698756, B714840, B715051, B721683, B745065, B753732, B763635, B763642, B802419;  PED3-027-400-16/00847536030886, 00847536035386, 00847536036703/B326193, B330879, B330881, B357080, B401867, B402034, B403012, B417737, B419736, B420127, B422990, B423257, B426548, B438677, B439156, B439301, B445198, B449040, B449149, B449591, B453559, B454843, B459846, B460523, B465307, B469682, B474417, B560503, B575892, B578340, B597083, B603196, B608221, B611268, B615571, B623135, B623136, B625944, B625945, B672865, B678987, B694225, B694934, B699098, B715043, B721778, B721782, B730828, B730829, B738422, B738423, B739914, B744842, B744860, B766155, B766701, B769315, B776922, B776933, B777378, B791207;  PED3-027-400-18/00847536036710/B795091;  PED3-027-400-20/00847536030909, 00847536035409, 00847536036727/B318459, B329314, B329316, B338468, B368540, B374265, B380481, B381434, B383600, B384092, B384233, B388982, B391816, B420182, B420318, B423735, B439714, B441852, B449699, B450256, B460915, B461092, B461510, B465420, B470193, B475106, B478030, B485264, B487677, B557537, B565556, B571634, B575122, B576711, B577356, B578341, B631830, B632949, B635238, B636674, B649884, B654937, B657799, B658273, B658540, B659188, B659211, B666546, B671140, B679007, B680109, B692381, B692536, B692916, B693469, B705994, B722574, B722592, B730946, B739972, B741664, B741666, B746709, B752946, B753532, B756807, B756808, B763701, B778174, B778192, B778193, B778534, B778535, B781327, B781347, B791327, B811796;  PED3-027-400-25/00847536030916, 00847536035416, 00847536036734/B322422, B394134, B400793, B411501, B415161, B424676, B432804, B442338, B470284, B474964, B481516, B483308, B568647, B576712, B577358, B634985, B636192, B648012, B649383, B661189, B675951, B689989, B704525, B706229, B706230, B709931, B712123, B726423, B741049, B741051, B747537, B747541, B754030, B765519, B776777, B777166, B780003, B780520, B786557;  PED3-027-400-30/00847536030923, 00847536035423, 00847536036741/B394830, B401265, B413855, B415343, B415743, B444760, B470728, B475566, B484529, B594121, B603201, B608917, B616555, B622661, B623126, B637143, B675952, B681380, B681596, B711437, B711438, B723555, B731515, B731516, B741809, B764098, B778206, B778207, B798796;  PED3-027-450-12/00847536030961, 00847536035461, 00847536036789/B322748, B456666, B471328, B486866, B575963, B601277, B637185, B666423, B703226, B706228, B708791, B711095, B750794, B751129, B758665, B758666, B758667, B794235;  PED3-027-450-14/00847536030978, 00847536035478, 00847536036796/B320465, B336565, B340244, B351032, B374880, B404541, B425289, B432042, B462206, B470900, B477408, B481700, B483148, B601181, B604476, B617556, B637191, B669563, B669568, B675953, B692841, B694794, B696125, B697448, B704465, B709288, B711828, B719080, B719084, B741791, B745142, B745143, B751967, B753463, B772618, B814124;  PED3-027-450-16/00847536030985, 00847536035485, 00847536036802/B318562, B331383, B331528, B340320, B351038, B374958, B384705, B385273, B395007, B405061, B407737, B424599, B450972, B465971, B471455, B483899, B485855, B535234, B552285, B568744, B571592, B585330, B596585, B622035, B625593, B626044, B628700, B629503, B643420, B659204, B659718, B660616, B661809, B666550, B666589, B668758, B669369, B675954, B682011, B698182, B723071, B723072, B723787, B723791, B735828, B735829, B735830, B746751, B746752, B753483, B757640, B757645, B762226, B762228, B764394, B787789, B789383, B803301;   PED3-027-450-18/00847536036819/B797308;  PED3-027-450-20/00847536031005, 00847536035508, 00847536036826/B325710, B328706, B328709, B355336, B357077, B357672, B377120, B381729, B389289, B390355, B397986, B419639, B421094, B423116, B425691, B440190, B440356, B440859, B442521, B449796, B450384, B451092, B452205, B461652, B462339, B464094, B480010, B481041, B487030, B549631, B550980, B557508, B569276, B573461, B574475, B584490, B585331, B594727, B632801, B635651, B650035, B651312, B651584, B652220, B669427, B673379, B674005, B681938, B696501, B696960, B700714, B700961, B703735, B705508, B728234, B729519, B732220, B752592, B758912, B758914, B760821, B774880, B776153, B794615, B794620, B798765, B810476, B811668;  PED3-027-450-25/00847536031012, 00847536035515, 00847536036833/B319170, B352790, B370633, B395978, B403146, B408241, B419571, B425960, B443719, B453438, B453676, B463202, B467023, B471895, B472002, B488714, B558531, B590206, B596591, B597131, B600999, B604474, B604478, B611115, B613070, B616042, B645444, B645874, B646698, B652027, B654357, B681223, B681901, B693373, B696977, B697584, B699639, B699762, B730899, B751210, B751305, B752452, B759553, B759554, B775532, B800797;  PED3-027-450-30/00847536031029, 00847536035522, 00847536036840/B396144, B404416, B411353, B434096, B436536, B535757, B561797, B574352, B616037, B644866, B645276, B651451, B652656, B654460, B658656, B659930, B675955, B688941, B713232, B714797, B714798, B717097, B730298, B731601, B731603, B784372, B785363, B810615, B815818;  PED3-027-450-40/00847536031043, 00847536035546, 00847536036864/B353358, B377744, B411399, B448343, B549634, B559739, B615408, B623125, B637017, B675956, B683288, B684783, B699735, B699776, B704439, B710043, B710051, B733018, B761384, B761385, B761386, B764292, B778738, B778836, B786518;  PED3-027-500-14/00847536031067, 00847536035577, 00847536036895/B353371, B411952, B425824, B432210, B447358, B455035, B455951, B601160, B603379, B606137, B624428, B637037, B651443, B674478, B675957, B685652, B701387, B706116, B706164, B710564, B710571, B711705, B729531, B764751, B765289, B785958, B790520;  PED3-027-500-16/00847536031074, 00847536035584, 00847536036901/B320910, B353996, B375682, B425116, B426932, B432683, B441009, B479353, B536475, B558194, B568648, B622122, B622123, B638485, B638487, B644714, B645376, B647467, B649263, B652167, B652663, B654363, B655727, B683524, B703758, B704315, B704999, B710455, B729572, B730327, B785458, B785792, B785793, B807437, B809811;  PED3-027-500-18/00847536036918/B797650;  PED3-027-500-20/00847536031098, 00847536035607, 00847536036925/B326325, B331608, B341953, B354635, B370450, B377872, B381636, B386124, B396652, B416028, B426418, B443827, B456058, B457830, B466125, B472700, B476324, B479966, B485115, B566387, B590194, B596594, B603380, B645491, B645898, B645962, B647222, B650050, B651347, B677890, B678397, B678959, B679068, B684999, B695686, B705596, B705610, B707567, B707606, B717655, B727541, B734039, B737927, B737928, B752681, B763087, B772659, B773371, B773372, B779449, B779450, B779633;  PED3-027-500-25/00847536031104, 00847536035614, 00847536036932/B354639, B382191, B387287, B396748, B413971, B417560, B472568, B478679, B536229, B570707, B603199, B646445, B648039, B680655, B688975, B689445, B693010, B694374, B695076, B700554, B702913, B720212, B720213, B720231, B747329, B747330, B747332, B751359, B761968, B763427, B800923;  PED3-027-500-30/00847536031111, 00847536035621, 00847536036949/B337320, B342643, B358320, B378426, B382386, B382844, B401379, B427074, B428049, B428522, B429875, B435865, B436340, B445405, B452880, B456544, B596584, B598708, B606136, B623128, B655004, B655034, B655744, B663561, B666422, B668512, B669368, B669370, B707244, B728433, B743037, B743038, B743039, B750658, B751192, B752314, B752315, B779538;  PED3-027-500-40/00847536031135, 00847536035645, 00847536036963/B319346, B340946, B373012, B373062, B374156, B379194, B397871, B398496, B456742, B457215, B464764, B467126, B473757, B482175, B567777, B573469, B585305, B590192, B677757, B682747, B693594, B701050, B703777, B703949, B707108, B710395, B711021, B711022, B736159, B747948, B749861, B753183, B753184, B762889, B773500;  PED3-027-550-16/00847536031166, 00847536035683, 00847536037007/B358321, B369526, B452971, B497779, B575962, B580922, B622743, B623127, B686266, B689577, B707045, B707126, B708154, B708159, B720912, B720913, B739371, B749920, B782490, B806751;  PED3-027-550-18/00847536037014/B803199;  PED3-027-550-20/00847536035706, 00847536031180, 00847536037021/B412256, B417797, B446018, B454303, B496490, B560727, B565445, B578965, B615897, B623137, B623138, B690738, B691319, B692483, B695336, B713205, B713214, B717726, B731786, B731789, B740657, B741946, B764254, B764286, B766393, B766406, B780554, B781697, B800693, B808083;  PED3-027-550-30/00847536031203, 00847536035720, 00847536037045/B397247, B408458, B414706, B416571, B473971, B475784, B479273, B494116, B608410, B611882, B615380, B663584, B666410, B695406, B696119, B697734, B709920, B713734, B713735, B729710, B738501, B738502, B746449, B783057, B783239, B783566;  PED3-027-550-40/00847536031227, 00847536035744, 00847536037069/B358931, B378536, B389916, B409027, B433336, B437033, B454059, B493075, B494673, B612534, B615604, B616547, B652056, B654234, B655595, B671064, B672455, B672476, B684986, B704973, B706035, B707059, B717259, B717261, B742095, B750469, B761584, B768849, B771892, B771893, B773963, B778320, B778326, B780176;  PED3-027-550-50/00847536031241, 00847536035768, 00847536037083/B397414, B412119, B431531, B435644, B437187, B616028, B637697, B658014, B705133, B717320, B717336, B717341, B724924, B745389, B745405, B745974, B749926, B785200, B785874;  PED3-027-600-16/00847536031289, 00847536035805, 00847536037120/B368960, B454127, B603197, B607478, B611280, B611281, B690544, B691908, B693533, B709546, B720780, B732968, B762785, B801322;  PED3-027-600-18/00847536037137/B801452;  PED3-027-600-20/00847536031302, 00847536035829, 00847536037144/B317266, B338536, B376423, B412355, B446526, B491096, B596581, B608223, B624427, B624430, B681791, B682681, B698133, B701028, B708016, B708642, B709539, B713242, B720316, B720318, B747892, B747893, B761449, B769429, B805791;  PED3-027-600-30/00847536031326, 00847536035843, 00847536037168/B339559, B412787, B457289, B467222, B489389, B594600, B597081, B611169, B611170, B626128, B652141, B653242, B654415, B681946, B682043, B701346, B711916, B712145, B719705, B726352, B726417, B728348, B735171, B748081, B748545, B748565, B758585, B808813;  PED3-027-600-40/00847536031340, 00847536035867, 00847536037182/B320318, B337325, B360226, B369513, B379020, B419419, B480964, B485981, B485982, B549767, B552409, B559740, B567778, B608855, B618581, B622005, B655601, B655798, B669603, B694091, B695569, B699270, B711618, B716111, B720752, B721600, B742928, B745966, B758046, B758050, B760363, B767594, B790633, B800873;  PED3-027-600-50/00847536031364, 00847536035881, 00847536037205/B327190, B332681, B342121, B403885, B415948, B428706, B429330, B433507, B434230, B457419, B557587, B617560, B623582, B626133, B651590, B652749, B653261, B653391, B658476, B658484, B670055, B670398, B673424, B680095, B695531, B703875, B713824, B714234, B726282, B732261, B732262, B732459, B733700, B746625, B758339, B758371, B768841, B783879, B783888, B788852, B790033, B794845",
            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 9,
          "item": {
            "Field": "Distribution pattern",
            "Value": "Worldwide distribution: US (nationwide): PR, OK, CA, MD, FL, NY, WA, MI, AL, NV, MN, NJ, IL, OH, AK, CT, TN, MO, TX, ID, AZ, WI, PA, OR, SD, VA, CO, GA, KY, IN, AR, MA, LA, NE, MT, ME, SC, DC, NC, ND, NM, IA, UT, KS, WV, NH, HI, RI. And OUS (foreign) countries of: Algeria, Argentina, Armenia, Australia, Austria, Bahrain, Bangladesh, Belgium, Brazil, Bulgaria, Canada, Canary Islands, Chile, Colombia, Costa Rica, Croatia, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, Finland, France, Germany, Greece, Hong Kong, Hungary, Iceland, India, Ireland, Israel, Italy, Jordan, Kazakhstan, Kuwait, Latvia, Lebanon, Lithuania, Luxembourg, Malaysia, Martinique, Mexico, Republic Of Moldova, Montenegro, Morocco, Netherlands, New Zealand, North Macedonia, Northern Ireland, Norway, Panama, Peru, Philippines, Poland, Portugal, Qatar, Reunion, Romania, Russia, Saudi Arabia, Serbia, Singapore, Slovakia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Tunisia, Turkey, Ukraine, United Arab Emirates, United Kingdom, Uruguay, Vietnam",
            "Status": "recorded"
          }
        }
      ]
    }
  ]
}