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  "@type": "schema:Dataset",
  "name": "MiniMed Insulin Pump Device. MiniMed 670G, REF: MMT-1580, MMT-1581, MMT-1582, MMT-1780, MMT-1781, MMT-1782, MMT-1740, MMT-1741, MMT-1742, MMT-1760, MMT-1761, MMT-1762;  MiniMed 770G, REF: MMT-1880, MMT-1881, MMT-1882, MMT-1890, MMT-1891, MMT-1892;  MiniMed 780G, REF: MMT-1884, MMT-1885, MMT-1886, MMT-1894, MMT-1895, MMT-1896",
  "description": "FDA recall Z-0003-2025 — Medtronic MiniMed, Inc. is recalling MiniMed Insulin Pump Device. MiniMed 670G, REF: MMT-1580, MMT-1581, MMT-1582, MMT-1780, MMT-1781, MMT-1782, MMT-1740, MMT-1741, MMT-1742, MMT-1760, MMT-1761, MMT-1762;  MiniMed 770G, REF: MMT-1880, MMT-1881, MMT-1882, MMT-1890, MMT-1891, MMT-1892;  MiniMed 780G, REF: MMT-1884, MMT-1885, MMT-1886, MMT-1894, MMT-1895, MMT-1896 (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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    "name": "openFDA drug & device enforcement (recall) reports",
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  "sameAs": "https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?action=select&recall_number=Z-0003-2025&lang=eng",
  "about": {
    "@type": "schema:MedicalDevice",
    "name": "MiniMed Insulin Pump Device. MiniMed 670G, REF: MMT-1580, MMT-1581, MMT-1582, MMT-1780, MMT-1781, MMT-1782, MMT-1740, MMT-1741, MMT-1742, MMT-1760, MMT-1761, MMT-1762;  MiniMed 770G, REF: MMT-1880, MMT-1881, MMT-1882, MMT-1890, MMT-1891, MMT-1892;  MiniMed 780G, REF: MMT-1884, MMT-1885, MMT-1886, MMT-1894, MMT-1895, MMT-1896",
    "manufacturer": {
      "@type": "schema:Organization",
      "name": "Medtronic MiniMed, Inc."
    }
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  "claims": [
    {
      "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-0003-2025/enforcement-record",
      "@type": "schema:Claim",
      "name": "FDA recall Z-0003-2025: Medtronic MiniMed, Inc. is recalling MiniMed Insulin Pump Device. MiniMed 670G, REF: MMT-1580, MMT-1581, MMT-1582, MMT-1780, MMT-1781, MMT-1782, MMT-1740, MMT-1741, MMT-1742, MMT-1760, MMT-1761, MMT-1762;  MiniMed 770G, REF: MMT-1880, MMT-1881, MMT-1882, MMT-1890, MMT-1891, MMT-1892;  MiniMed 780G, REF: MMT-1884, MMT-1885, MMT-1886, MMT-1894, MMT-1895, MMT-1896",
      "text": "The FDA logged enforcement record Z-0003-2025: Medtronic MiniMed, Inc. is voluntarily recalling MiniMed Insulin Pump Device. MiniMed 670G, REF: MMT-1580, MMT-1581, MMT-1582, MMT-1780, MMT-1781, MMT-1782, MMT-1740, MMT-1741, MMT-1742, MMT-1760, MMT-1761, MMT-1762;  MiniMed 770G, REF: MMT-1880, MMT-1881, MMT-1882, MMT-1890, MMT-1891, MMT-1892;  MiniMed 780G, REF: MMT-1884, MMT-1885, MMT-1886, MMT-1894, MMT-1895, MMT-1896 — reason: Insulin pumps that have been dropped, bumped, or experienced physical impact may have damage to internal electrical components, which may cause reduced pump battery life. Since the defect reduces the battery life overall, it shortens the time between low battery alarms and increases the frequency with which the user must insert a new battery. Further, the defect may also deliver the low battery alarm when there is significantly less time before the battery completely runs out, from the expected up to 10-hour buffer the low alert is supposed to signal, leading to device powering down and stopping insulin delivery unexpectedly. Per the firm, a subset of pumps with the defect showed the low alert alarm was delivered ~2.5 hours before the device shut off, however, patient reports indicate the time could be even shorter. Replacing the battery will not resolve this issue and the short battery life and the truncated low battery alert lead time will continue to occur. Early battery depletion could result in power loss and insulin delivery could be interrupted, resulting in under delivery of insulin potentially leading to hyperglycemia and/or DKA.. Status: Ongoing — the recall is still being carried out.. Initiated 2024-07-31. Affected lots/codes: REF/UDI-DI(GTIN):  MMT-1780/00763000190453, 00643169946057, 00763000365882, 00763000096984, 00763000283445, 763000283513, 763000283506, 763000365882, 763000283520, 76300028351303, 763000393786, 763000166526, 76300028351301, 643169939202, 763000190460, 763000090203, 763000256821, 643169939219, 763000072537, 763000365912, 00763000090203, 00763000190460, 00763000283520, 00763000393786;  MMT-1781/00763000187415, 00763000283568, 00763000283544, 00763000404536, 00763000283551, 00763000283537, 00763000365899, 00763000371937, 00763000225575, 00763000225582, 00763000235765, 00763000187378, 00763000140601, 763000240707, 763000187378, 763000140601, 763000283544;  MMT-1782/00763000187422, 00763000235772, 00763000283599, 00763000264727, 00763000404543, 00763000283582, 00763000371944, 00763000365905, 00763000283575, 00643169957640, 00763000157463, 00763000225612, 763000225629, 763000225612, 763000264727;  MMT-1741/00763000408916, 00763000408930;  MMT-1742/00763000408947, 00763000250232, 00763000408954;  MMT-1760/763000278427, 763000283445, 643169946057, 763000190453, 763000096984, 643169946040, 00643169946057, 00763000190453, 00763000283445, 763000367084, 763000179649, 763000395858, 00763000096984;  MMT-1761/763000187392, 00763000165451, 00763000165420, 00763000165468, 00763000165444, 00763000165437, 00763000257309, 00763000165413, 00763000289065, 00763000289089, 00763000289041, 00763000367657, 00763000289195, 00763000289096, 00763000289072, 00763000289058, 00763000324797, 00763000374518, 00763000374532, 00763000374525, 00763000374556, 00763000399849, 00763000399856, 00763000374587, 763000367657;  MMT-1762/763000264710, 00763000264710, 00763000165475, 00763000165482, 00763000165499, 00763000165505, 00763000165512, 00763000165529, 00763000165536, 00763000165543, 00763000165550, 00763000203313, 00763000216481, 00763000252076, 00763000283476, 00763000289102, 00763000289119, 00763000289126, 00763000289133, 00763000289140, 00763000289164, 00763000289171, 00763000289188, 00763000324780, 00763000374594, 00763000374600, 00763000374624, 00763000399986;  MMT-1880/00763000414344, 00763000545604, 00763000439859, 763000578640, 763000586195, 76300058619502, 763000439866, 763000413750, 76300057864002, 763000414344, 763000545604, 763000640095, 763000439859, 76300058619501, 00763000413750, 00763000586188;  MMT-1881/00763000416546, 00763000439903, 00763000629892, 763000416546;  MMT-1882/00763000416553, 00763000439910, 00763000545505, 00763000629908;  MMT-1890/763000545604, 763000414344, 763000439859, 763000640095, 00763000414344, 00763000439859, 00763000545604, 76300054560402, 00763000640095, 76300064009502;  MMT-1891/00763000642242, 00763000456634, 00763000642235, 00763000418151, 00763000482596;  MMT-1892/00763000416553, 00763000439910, 00763000545505, 00763000629908;  MMT-1884/00763000414344, 76300081937801, 76300081938501, 763000819378, 763000819385, 00763000586195, A7630007585401, 00763000758547, 00763000439866, 00763000578640, 00763000439859, 00763000545604, 00763000640095, 00763000819392, 763000545604, 00763000758530, 00763000504762;  MMT-1885/00763000384258, 00763000521523, 00763000442187, 00763000521509, 00763000578671, 00763000639228, 00763000421939, 00763000597900, 00763000854942, 00763000854829, A7630006392201, 763000384272, 763000521523, 763000854829;  MMT-1886/00763000384265, 00763000441449, 00763000521530, 00763000521516, 00763000578688, 00763000442194, 00763000639235, 763000384289, 763000521530, 76300044240801, 763000688165, 76300063923501;  MMT-1894/76300086566501, 76300075854701, 763000758547, 763000819392, 763000865665, 00763000758547, 00763000819392;  MMT-1895/00763000411411, 00763000734435, 00763000411473, 00763000411466, 00763000541569, 00763000411480, 00763000420703, 00763000411428, 00763000596217, 00763000411404, 00763000533861, 00763000411381, 00763000411503, 00763000596187, 00763000411398, 00763000596194, 00763000411374, 00763000411442, 00763000411435, 00763000411497, 00763000411459, 00763000596224, 00763000411633, 00763000596231, 00763000639266, 00763000384272, 00763000521547, 00763000732585, 763000734435;  MMT-1896/763000521554,00763000411510, 00763000411565, 00763000411640, 00763000411541, 00763000411589, 00763000734442, 00763000411527, 00763000411626, 00763000411602, 00763000411558, 00763000523305, 00763000411572, 00763000411596, 00763000914127, 00763000411619, 00763000411534, 00763000734459, 00763000544317, 00763000913250, 00763000533878, 00763000521554, 00763000384289, 00763000639273, 763000734442;  All serial numbers.. A RECORDED FDA enforcement action (occurred=true).",
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      "reviewStatus": "current",
      "commercialInfluence": false,
      "epistemicStatus": {
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        "adjudged": true,
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        "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-0003-2025&lang=eng",
        "value": "Devices recall, status Ongoing",
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          "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-0003-2025&lang=eng"
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      "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-0003-2025/fda-classification",
      "@type": "schema:Claim",
      "name": "FDA classified recall Z-0003-2025 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
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      "grounding": {
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        "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-0003-2025&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-0003-2025&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-0003-2025/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
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      "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."
    }
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            "Value": "Devices",
            "Status": "recorded"
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            "Value": "Class I",
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            "Value": "Ongoing — the recall is still being carried out.",
            "Status": "recorded"
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          "position": 5,
          "item": {
            "Field": "Recalling firm",
            "Value": "Medtronic MiniMed, Inc.",
            "Status": "recorded"
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          "position": 6,
          "item": {
            "Field": "Reason",
            "Value": "Insulin pumps that have been dropped, bumped, or experienced physical impact may have damage to internal electrical components, which may cause reduced pump battery life. Since the defect reduces the battery life overall, it shortens the time between low battery alarms and increases the frequency with which the user must insert a new battery. Further, the defect may also deliver the low battery alarm when there is significantly less time before the battery completely runs out, from the expected up to 10-hour buffer the low alert is supposed to signal, leading to device powering down and stopping insulin delivery unexpectedly. Per the firm, a subset of pumps with the defect showed the low alert alarm was delivered ~2.5 hours before the device shut off, however, patient reports indicate the time could be even shorter. Replacing the battery will not resolve this issue and the short battery life and the truncated low battery alert lead time will continue to occur. Early battery depletion could result in power loss and insulin delivery could be interrupted, resulting in under delivery of insulin potentially leading to hyperglycemia and/or DKA.",
            "Status": "recorded"
          }
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          "item": {
            "Field": "Initiated",
            "Value": "2024-07-31",
            "Status": "recorded"
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          "item": {
            "Field": "Lot/code info",
            "Value": "REF/UDI-DI(GTIN):  MMT-1780/00763000190453, 00643169946057, 00763000365882, 00763000096984, 00763000283445, 763000283513, 763000283506, 763000365882, 763000283520, 76300028351303, 763000393786, 763000166526, 76300028351301, 643169939202, 763000190460, 763000090203, 763000256821, 643169939219, 763000072537, 763000365912, 00763000090203, 00763000190460, 00763000283520, 00763000393786;  MMT-1781/00763000187415, 00763000283568, 00763000283544, 00763000404536, 00763000283551, 00763000283537, 00763000365899, 00763000371937, 00763000225575, 00763000225582, 00763000235765, 00763000187378, 00763000140601, 763000240707, 763000187378, 763000140601, 763000283544;  MMT-1782/00763000187422, 00763000235772, 00763000283599, 00763000264727, 00763000404543, 00763000283582, 00763000371944, 00763000365905, 00763000283575, 00643169957640, 00763000157463, 00763000225612, 763000225629, 763000225612, 763000264727;  MMT-1741/00763000408916, 00763000408930;  MMT-1742/00763000408947, 00763000250232, 00763000408954;  MMT-1760/763000278427, 763000283445, 643169946057, 763000190453, 763000096984, 643169946040, 00643169946057, 00763000190453, 00763000283445, 763000367084, 763000179649, 763000395858, 00763000096984;  MMT-1761/763000187392, 00763000165451, 00763000165420, 00763000165468, 00763000165444, 00763000165437, 00763000257309, 00763000165413, 00763000289065, 00763000289089, 00763000289041, 00763000367657, 00763000289195, 00763000289096, 00763000289072, 00763000289058, 00763000324797, 00763000374518, 00763000374532, 00763000374525, 00763000374556, 00763000399849, 00763000399856, 00763000374587, 763000367657;  MMT-1762/763000264710, 00763000264710, 00763000165475, 00763000165482, 00763000165499, 00763000165505, 00763000165512, 00763000165529, 00763000165536, 00763000165543, 00763000165550, 00763000203313, 00763000216481, 00763000252076, 00763000283476, 00763000289102, 00763000289119, 00763000289126, 00763000289133, 00763000289140, 00763000289164, 00763000289171, 00763000289188, 00763000324780, 00763000374594, 00763000374600, 00763000374624, 00763000399986;  MMT-1880/00763000414344, 00763000545604, 00763000439859, 763000578640, 763000586195, 76300058619502, 763000439866, 763000413750, 76300057864002, 763000414344, 763000545604, 763000640095, 763000439859, 76300058619501, 00763000413750, 00763000586188;  MMT-1881/00763000416546, 00763000439903, 00763000629892, 763000416546;  MMT-1882/00763000416553, 00763000439910, 00763000545505, 00763000629908;  MMT-1890/763000545604, 763000414344, 763000439859, 763000640095, 00763000414344, 00763000439859, 00763000545604, 76300054560402, 00763000640095, 76300064009502;  MMT-1891/00763000642242, 00763000456634, 00763000642235, 00763000418151, 00763000482596;  MMT-1892/00763000416553, 00763000439910, 00763000545505, 00763000629908;  MMT-1884/00763000414344, 76300081937801, 76300081938501, 763000819378, 763000819385, 00763000586195, A7630007585401, 00763000758547, 00763000439866, 00763000578640, 00763000439859, 00763000545604, 00763000640095, 00763000819392, 763000545604, 00763000758530, 00763000504762;  MMT-1885/00763000384258, 00763000521523, 00763000442187, 00763000521509, 00763000578671, 00763000639228, 00763000421939, 00763000597900, 00763000854942, 00763000854829, A7630006392201, 763000384272, 763000521523, 763000854829;  MMT-1886/00763000384265, 00763000441449, 00763000521530, 00763000521516, 00763000578688, 00763000442194, 00763000639235, 763000384289, 763000521530, 76300044240801, 763000688165, 76300063923501;  MMT-1894/76300086566501, 76300075854701, 763000758547, 763000819392, 763000865665, 00763000758547, 00763000819392;  MMT-1895/00763000411411, 00763000734435, 00763000411473, 00763000411466, 00763000541569, 00763000411480, 00763000420703, 00763000411428, 00763000596217, 00763000411404, 00763000533861, 00763000411381, 00763000411503, 00763000596187, 00763000411398, 00763000596194, 00763000411374, 00763000411442, 00763000411435, 00763000411497, 00763000411459, 00763000596224, 00763000411633, 00763000596231, 00763000639266, 00763000384272, 00763000521547, 00763000732585, 763000734435;  MMT-1896/763000521554,00763000411510, 00763000411565, 00763000411640, 00763000411541, 00763000411589, 00763000734442, 00763000411527, 00763000411626, 00763000411602, 00763000411558, 00763000523305, 00763000411572, 00763000411596, 00763000914127, 00763000411619, 00763000411534, 00763000734459, 00763000544317, 00763000913250, 00763000533878, 00763000521554, 00763000384289, 00763000639273, 763000734442;  All serial numbers.",
            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 9,
          "item": {
            "Field": "Distribution pattern",
            "Value": "US: CT, MI, PA, WA, IA, NY, ND, AZ, TX, OH, NC, AL, MN, IN, NJ, KY, UT, CA, FL, VA, MS, NM, NV, TN, GA, MA, NH, OK, VT, IL, ME, SC, LA, WY, RI, SD, KS, WI, MD, CO, DE, AR, AK, ID, MO, NE, WV, MT, OR, DC, HI, VI, PR.  OUS: Worldwide",
            "Status": "recorded"
          }
        }
      ]
    }
  ]
}