{ "@context": { "schema": "https://schema.org/", "au": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/vocab/agent-native#", "@vocab": "https://schema.org/", "claims": { "@id": "au:claims", "@container": "@list" }, "epistemicStatus": "au:epistemicStatus", "occurred": "au:occurred", "supported": "au:supported", "adjudged": "au:adjudged", "operative": "au:operative", "grounding": "au:grounding", "groundingType": "au:groundingType", "adjudicator": "au:adjudicator", "source": "au:source", "sourceUrl": "au:sourceUrl", "value": "au:value", "claimType": "au:claimType", "reviewStatus": "au:reviewStatus", "commercialInfluence": "au:commercialInfluence", "falsifier": "au:falsifier" }, "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-1745-2023.jsonld", "@type": "schema:Dataset", "name": "CRT-D DTBB2D1 VIVA S IS1/DF1 INTL, Model Number DTBB2D1; Implantable Cardioverter Defibrillators", "description": "FDA recall Z-1745-2023 — Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) is recalling CRT-D DTBB2D1 VIVA S IS1/DF1 INTL, Model Number DTBB2D1; Implantable Cardioverter Defibrillators (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.", "license": "https://creativecommons.org/publicdomain/zero/1.0/", "isAccessibleForFree": true, "isPartOf": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/", "rdfs:isDefinedBy": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/vocab/agent-native", "seeAlso": "https://agenticu.ryanjhunter.workers.dev/commons/the-research-object", "dateModified": "2026-06-24T07:02:03.626072+00:00", "isBasedOn": { "@type": "schema:Dataset", "name": "openFDA drug & device enforcement (recall) reports", "url": "https://open.fda.gov/apis/drug/enforcement/", "creator": { "@type": "schema:GovernmentOrganization", "name": "U.S. Food & Drug Administration" } }, "sameAs": "https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?action=select&recall_number=Z-1745-2023&lang=eng", "about": { "@type": "schema:MedicalDevice", "name": "CRT-D DTBB2D1 VIVA S IS1/DF1 INTL, Model Number DTBB2D1; Implantable Cardioverter Defibrillators", "manufacturer": { "@type": "schema:Organization", "name": "Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)" } }, "claims": [ { "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-1745-2023/enforcement-record", "@type": "schema:Claim", "name": "FDA recall Z-1745-2023: Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) is recalling CRT-D DTBB2D1 VIVA S IS1/DF1 INTL, Model Number DTBB2D1; Implantable Cardioverter Defibrillators", "text": "The FDA logged enforcement record Z-1745-2023: Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) is voluntarily recalling CRT-D DTBB2D1 VIVA S IS1/DF1 INTL, Model Number DTBB2D1; Implantable Cardioverter Defibrillators — reason: There is a rare potential for reduced- or no-energy output during high voltage (HV) therapy (typically 0-12J) in implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds) manufactured with a specific (glassed) feedthrough, including currently available ICDs and CRT-Ds.. Status: Ongoing — the recall is still being carried out.. Initiated 2023-05-10. Affected lots/codes: GTIN 00643169720350, Lot Serial Numbers: BLS604430S, BLS604248S, BLS604229S, BLS604258S, BLS604234S, BLS604223S, BLS604309S, BLS604224S, BLS604227S, BLS604222S, BLS604308S, BLS604256S, BLS604257S, BLS604310S, BLS604313S, BLS604245S, BLS604253S, BLS604252S, BLS604239S, BLS604226S, BLS604371S, BLS604380S, BLS604417S, BLS604419S, BLS604432S, BLS604560S, BLS604562S, BLS604366S, BLS604368S, BLS604375S, BLS604376S, BLS604169S, BLS604170S, BLS604360S, BLS604365S, BLS604369S, BLS604372S, BLS604379S, BLS604525S, BLS604554S, BLS604572S, BLS604363S, BLS604171S, BLS604361S, BLS604377S, BLS604378S, BLS604418S, BLS604428S, BLS604434S, BLS604556S, BLS604561S, BLS604567S, BLS604571S, BLS604563S, BLS604362S, BLS604364S, BLS604370S, BLS604373S, BLS604422S, BLS604523S, BLS604524S, BLS604543S, BLS604548S, BLS604564S, BLS604570S, BLS604279S, BLS604280S, BLS604281S, BLS604316S, BLS604320S, BLS604321S, BLS604322S, BLS604323S, BLS604324S, BLS604326S, BLS604328S, BLS604317S, BLS604318S, BLS604319S, BLS604416S, BLS604421S, BLS604243S, BLS604305S, BLS604399S, BLS604503S, BLS604549S, BLS604367S, BLS604345S, BLS604501S, BLS604410S, BLS604502S, BLS604528S, BLS604325S, BLS604384S, BLS604391S, BLS604392S, BLS604400S, BLS604487S, BLS604496S, BLS604385S, BLS604386S, BLS604520S, BLS604521S, BLS604390S, BLS604397S, BLS604406S, BLS604526S, BLS604527S, BLS604382S, BLS604408S, BLS604249S, BLS604250S, BLS604387S, BLS604388S, BLS604389S, BLS604393S, BLS604413S, BLS604414S, BLS604457S, BLS604458S, BLS604459S, BLS604460S, BLS604494S, BLS604495S, BLS604497S, BLS604498S, BLS604499S, BLS604506S, BLS604517S, BLS604518S, BLS604519S, BLS604535S, BLS604536S, BLS604578S, BLS604586S, BLS604587S, BLS604590S, BLS604592S, BLS604273S, BLS604265S, BLS604396S, BLS604493S, BLS604579S, BLS604464S, BLS604475S, BLS604476S, BLS604477S, BLS604540S, BLS604547S, BLS604583S, BLS604588S, BLS604484S, BLS604485S, BLS604242S, BLS604546S, BLS604479S, BLS604409S, BLS604407S, BLS604456S, BLS604327S, BLS604329S, BLS604455S, BLS604480S, BLS604489S, BLS604507S, BLS604529S, BLS604585S, BLS604538S, BLS604511S, BLS604531S, BLS604532S, BLS604539S, BLS604541S, BLS604537S, BLS604344S, BLS604500S, BLS604433S, BLS604478S, BLS604551S, BLS604492S, BLS604504S, BLS604435S, BLS604510S, BLS604530S, BLS604584S, BLS604395S, BLS604463S, BLS604522S, BLS604553S, BLS604508S, BLS604552S, BLS604271S, BLS604533S, BLS604461S, BLS604462S, BLS604490S, BLS604568S, BLS604591S, BLS604488S, BLS604550S, BLS604381S, BLS604383S, BLS604513S, BLS604577S, BLS604251S, BLS604505S, BLS604509S, BLS604398S, BLS604481S, BLS604482S, BLS604483S, BLS604486S, BLS604542S, BLS604544S, BLS604569S, BLS604574S, BLS604575S, BLS604576S, BLS604589S, BLS604491S, BLS604512S, BLS604394S, BLS604411S, BLS604412S, BLS604534S, BLS604514S; GTIN 00643169980105, Lot Serial Numbers: BLS604445S, BLS604613S, BLS604737S, BLS604754S, BLS605210S, BLS604596S, BLS604658S, BLS604689S, BLS604721S, BLS604726S, BLS604730S, BLS604750S, BLS605135S, BLS605194S, BLS605200S, BLS604846S, BLS604866S, BLS604919S, BLS604930S, BLS604950S, BLS605180S, BLS605187S, BLS605199S, BLS605211S, BLS605216S, BLS605217S, BLS605220S, BLS605263S, BLS605285S, BLS605367S, BLS604835S, BLS604869S, BLS604882S, BLS604999S, BLS605198S, BLS605322S, BLS605368S, BLS604446S, BLS604448S, BLS604436S, BLS604447S, BLS604449S, BLS604441S, BLS604438S, BLS604451S, BLS604474S, BLS604650S, BLS604662S, BLS604663S, BLS604768S, BLS605430S, BLS605431S, BLS604657S, BLS604659S, BLS604656S, BLS604708S, BLS604739S, BLS604766S, BLS604806S, BLS604815S, BLS604819S, BLS605235S, BLS605236S, BLS605331S, BLS605360S, BLS605353S, BLS604645S, BLS604649S, BLS604763S, BLS604793S, BLS604803S, BLS604804S, BLS604718S, BLS604812S, BLS604820S, BLS604822S, BLS605233S, BLS605358S, BLS604654S, BLS604647S, BLS604652S, BLS604725S, BLS604731S, BLS604738S, BLS604741S, BLS604805S, BLS604808S, BLS604809S, BLS604813S, BLS604817S, BLS604818S, BLS604655S, BLS604777S, BLS604811S, BLS604814S, BLS604821S, BLS605128S, BLS605193S, BLS605223S, BLS605270S, BLS605296S, BLS605328S, BLS605347S, BLS605348S, BLS605349S, BLS605355S, BLS605359S, BLS604437S, BLS604443S, BLS604444S, BLS604468S, BLS604473S, BLS604705S, BLS605482S, BLS605151S, BLS605152S, BLS605157S, BLS605329S, BLS605369S, BLS605372S, BLS605503S, BLS605505S, BLS605038S, BLS605309S, BLS605310S, BLS605312S, BLS604664S, BLS604717S, BLS604946S, BLS604980S, BLS605248S, BLS605274S, BLS605374S, BLS605406S, BLS604963S, BLS605281S, BLS605299S, BLS604736S, BLS604742S, BLS604758S, BLS604759S, BLS604761S, BLS604762S, BLS604840S, BLS604841S, BLS605017S, BLS605163S, BLS605189S, BLS605191S, BLS605195S, BLS605196S, BLS605197S, BLS605303S, BLS605304S, BLS605385S, BLS605390S, BLS605391S, BLS605493S, BLS604831S, BLS604839S, BLS604863S, BLS604864S, BLS604871S, BLS605186S, BLS605188S, BLS605202S, BLS605203S, BLS605206S, BLS605227S, BLS605243S, BLS605307S, BLS605356S, BLS605375S, BLS605472S, BLS604619S, BLS604623S, BLS604632S, BLS605070S, BLS605254S, BLS605373S, BLS605466S, BLS605470S, BLS604467S, BLS604597S, BLS604603S, BLS604605S, BLS604472S, BLS604684S, BLS604692S, BLS604694S, BLS604704S, BLS604872S, BLS605241S, BLS605343S, BLS605351S, BLS605450S, BLS605462S, BLS604710S, BLS605014S, BLS605131S, BLS605133S, BLS605134S, BLS605137S, BLS605234S, BLS605256S, BLS605276S, BLS605350S, BLS605396S, BLS605403S, BLS605492S, BLS605269S, BLS604642S, BLS604617S, BLS604702S, BLS604720S, BLS604764S, BLS605488S, BLS605336S, BLS605504S, BLS605212S, BLS605213S, BLS605222S, BLS605244S, BLS605245S, BLS605313S, BLS605314S, BLS605315S, BLS605316S, BLS605506S, BLS605259S, BLS605239S, BLS605240S, BLS605242S, BLS605258S, BLS605275S, BLS605297S, BLS605323S, BLS605337S, BLS605342S, BLS605381S, BLS605384S, BLS605453S, BLS605455S, BLS605458S, BLS605484S, BLS604779S, BLS604787S, BLS605060S, BLS605481S, BLS605090S, BLS605093S, BLS605094S, BLS605132S, BLS605136S, BLS605138S, BLS605230S, BLS605231S, BLS605232S, BLS605237S, BLS605238S, BLS605252S, BLS605253S, BLS605255S, BLS605257S, BLS605260S, BLS605261S, BLS605262S, BLS605265S, BLS605272S, BLS605273S, BLS605277S, BLS605380S, BLS605398S, BLS605452S, BLS604612S, BLS604712S, BLS604719S, BLS604728S, BLS604749S, BLS604756S, BLS605170S, BLS605395S, BLS605495S, BLS604688S, BLS604700S, BLS605388S, BLS605113S, BLS604651S, BLS604685S, BLS605156S, BLS605338S, BLS605371S, BLS605048S, BLS605051S, BLS605052S, BLS605053S, BLS605054S, BLS605056S, BLS605057S, BLS605058S, BLS605059S, BLS605061S, BLS605065S, BLS605074S, BLS605075S, BLS605077S, BLS605078S, BLS605079S, BLS605080S, BLS605081S, BLS605084S, BLS605086S, BLS604636S, BLS604637S, BLS604638S, BLS604639S, BLS604640S, BLS604676S, BLS604677S, BLS604909S, BLS604959S, BLS604960S, BLS604961S, BLS604962S, BLS605208S, BLS605378S, BLS605460S, BLS605465S, BLS605475S, BLS605497S, BLS604672S, BLS604674S, BLS604678S, BLS604679S, BLS604680S, BLS604681S, BLS605153S, BLS605155S, BLS605174S, BLS605175S, BLS605207S, BLS605209S, BLS605324S, BLS605332S, BLS605459S, BLS605463S, BLS605464S, BLS605474S, BLS605496S, BLS604873S, BLS605064S, BLS604800S, BLS604802S, BLS605171S, BLS605172S, BLS605173S, BLS605181S, BLS605282S, BLS605311S, BLS605169S, BLS605204S, BLS605205S, BLS605250S, BLS605317S, BLS605334S, BLS605387S, BLS605451S, BLS605457S, BLS605479S, BLS605480S, BLS605485S, BLS605486S, BLS604693S, BLS604711S, BLS604807S, BLS605344S, BLS605389S, BLS604781S, BLS604782S, BLS604795S, BLS604850S, BLS604853S, BLS605111S, BLS605280S, BLS605319S, BLS605379S, BLS605382S, BLS604626S, BLS604627S, BLS604630S, BLS604631S, BLS604714S, BLS604716S, BLS604733S, BLS604734S, BLS604735S, BLS604743S, BLS604744S, BLS604745S, BLS604747S, BLS604748S, BLS604686S, BLS604836S, BLS604907S, BLS604947S, BLS604646S, BLS605154S, BLS605468S, BLS604876S, BLS604917S, BLS604687S, BLS605112S, BLS604465S, BLS604471S, BLS604594S, BLS604595S, BLS604598S, BLS604669S, BLS604670S, BLS604675S, BLS604924S, BLS604982S, BLS605469S, BLS604713S, BLS604723S, BLS604599S, BLS604666S, BLS604668S, BLS604707S, BLS604837S, BLS604838S, BLS604922S, BLS604979S, BLS605335S, BLS605215S, BLS605392S, BLS605489S, BLS604801S, BLS604828S, BLS604829S, BLS604832S, BLS604833S, BLS605159S, BLS605224S, BLS605295S, BLS605302S, BLS605327S, BLS605339S, BLS605402S, BLS605346S, BLS604765S, BLS604767S, BLS604825S, BLS604826S, BLS604827S, BLS604834S, BLS604855S, BLS604856S, BLS604857S, BLS604858S, BLS604859S, BLS604860S, BLS604881S, BLS604901S, BLS604902S, BLS604903S, BLS604948S, BLS604949S, BLS604951S, BLS604952S, BLS605036S, BLS605037S, BLS605104S, BLS605246S, BLS605247S, BLS605288S, BLS605305S, BLS605383S, BLS605397S, BLS605399S, BLS605400S, BLS605476S, BLS605494S, BLS605499S, BLS604469S, BLS604621S, BLS604635S, BLS604941S, BLS605041S, BLS605067S, BLS605083S, BLS605264S, BLS605308S, BLS605386S, BLS605168S, BLS605013S, BLS605068S, BLS605467S, BLS605483S, BLS605182S, BLS605284S, BLS605286S, BLS605478S, BLS604682S, BLS605283S, BLS605201S, BLS605268S, BLS605039S, BLS605117S, BLS605118S, BLS605119S, BLS605249S, BLS605321S, BLS605490S, BLS605491S, BLS605016S, BLS604601S, BLS604660S, BLS604904S, BLS604923S, BLS604926S, BLS604928S, BLS604943S, BLS605271S, BLS605376S, BLS604732S, BLS604799S, BLS605001S, BLS604628S, BLS604661S, BLS604972S, BLS605404S, BLS604880S, BLS605394S, BLS605190S, BLS605454S, BLS605456S, BLS605228S, BLS605279S, BLS605426S, BLS605192S, BLS604936S, BLS604992S, BLS605096S, BLS605105S, BLS605106S, BLS605164S, BLS605165S, BLS605166S, BLS605167S, BLS605289S, BLS605290S, BLS605292S, BLS605293S, BLS605401S, BLS605498S, BLS605278S, BLS605471S, BLS604755S, BLS605393S, BLS605405S, BLS605294S, BLS605345S, BLS605354S, BLS604913S, BLS604641S, BLS604683S, BLS604823S, BLS604824S, BLS604830S, BLS604884S, BLS604885S, BLS604886S, BLS604887S, BLS604888S, BLS604889S, BLS604890S, BLS604891S, BLS604892S, BLS605251S, BLS605266S, BLS605267S, BLS605340S, BLS605341S, BLS605352S, BLS605361S, BLS605029S, BLS605219S, BLS605325S, BLS605326S, BLS605461S, BLS605473S, BLS605218S, BLS604604S, BLS604643S, BLS604724S, BLS604746S, BLS604751S, BLS604752S, BLS604753S, BLS604757S, BLS604774S, BLS604780S, BLS604784S, BLS604785S, BLS604786S, BLS604788S, BLS604789S, BLS604790S, BLS604791S, BLS604792S, BLS604842S, BLS604843S, BLS604845S, BLS604848S, BLS604849S, BLS605020S, BLS605298S, BLS605042S, BLS604653S, BLS604701S, BLS604709S, BLS605306S, BLS605214S, BLS605229S, BLS605333S, BLS605487S, BLS604602S, BLS604618S, BLS604620S, BLS604625S, BLS604629S, BLS604634S, BLS604644S, BLS604673S, BLS604691S, BLS605477S, BLS604671S, BLS604729S, BLS604796S, BLS605127S, BLS605185S, BLS605225S, BLS605226S, BLS605318S, BLS604773S, BLS604775S, BLS604776S, BLS604760S, BLS604794S, BLS604797S, BLS604798S, BLS604851S, BLS604852S, BLS604854S, BLS604861S, BLS604862S, BLS604865S, BLS604867S, BLS604870S, BLS604874S, BLS604875S, BLS604877S, BLS604878S, BLS604883S, BLS604893S, BLS604894S, BLS604895S, BLS604896S, BLS604897S, BLS604898S, BLS604899S, BLS604900S, BLS604905S, BLS604906S, BLS604908S, BLS604910S, BLS604911S, BLS604912S, BLS604914S, BLS604915S, BLS604916S, BLS604918S, BLS604920S, BLS604921S, BLS604925S, BLS604927S, BLS604929S, BLS604931S, BLS604932S, BLS604933S, BLS604934S, BLS604935S, BLS604937S, BLS604938S, BLS604939S, BLS604940S, BLS604942S, BLS604944S, BLS604945S, BLS604953S, BLS604954S, BLS604955S, BLS604956S, BLS604957S, BLS604958S, BLS604964S, BLS604965S, BLS604966S, BLS604967S, BLS604968S, BLS604969S, BLS604970S, BLS604971S, BLS604973S, BLS604974S, BLS604975S, BLS604976S, BLS604977S, BLS604978S, BLS604981S, BLS604983S, BLS604984S, BLS604985S, BLS604986S, BLS604987S, BLS604988S, BLS604989S, BLS604990S, BLS604991S, BLS604993S, BLS604994S, BLS604995S, BLS604996S, BLS604997S, BLS604998S, BLS605000S, BLS605002S, BLS605003S, BLS605004S, BLS605005S, BLS605006S, BLS605007S, BLS605008S, BLS605009S, BLS605010S, BLS605011S, BLS605012S, BLS605015S, BLS605018S, BLS605019S, BLS605021S, BLS605022S, BLS605023S, BLS605024S, BLS605025S, BLS605026S, BLS605027S, BLS605028S, BLS605030S, BLS605031S, BLS605032S, BLS605033S, BLS605034S, BLS605035S, BLS605040S, BLS605043S, BLS605044S, BLS605045S, BLS605046S, BLS605047S, BLS605049S, BLS605055S, BLS605062S, BLS605063S, BLS605066S, BLS605069S, BLS605071S, BLS605072S, BLS605073S, BLS605076S, BLS605082S, BLS605085S, BLS605087S, BLS605088S, BLS605089S, BLS605091S, BLS605092S, BLS605095S, BLS605097S, BLS605098S, BLS605099S, BLS605100S, BLS605101S, BLS605102S, BLS605107S, BLS605108S, BLS605109S, BLS605110S, BLS605114S, BLS605115S, BLS605116S, BLS605120S, BLS605121S, BLS605122S, BLS605123S, BLS605124S, BLS605125S, BLS605126S, BLS605129S, BLS605130S, BLS605139S, BLS605140S, BLS605141S, BLS605142S, BLS605143S, BLS605144S, BLS605145S, BLS605146S, BLS605147S, BLS605148S, BLS605149S, BLS605150S, BLS605158S, BLS605160S, BLS605161S, BLS605162S, BLS605176S, BLS605177S, BLS605178S, BLS605179S, BLS605183S, BLS605184S, BLS605370S, BLS605221S, BLS605300S, BLS605301S, BLS605330S, BLS605287S, BLS605291S, BLS605357S, BLS605362S, BLS605363S, BLS605364S, BLS605377S; GTIN 00763000612276, Lot Serial Numbers: BLS605515S, BLS605514S, BLS605508S, BLS605509S, BLS605507S. 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-1745-2023&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-1745-2023&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-1745-2023/fda-classification", "@type": "schema:Claim", "name": "FDA classified recall Z-1745-2023 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-1745-2023&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-1745-2023&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-1745-2023/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-1745-2023", "numberOfItems": 9, "itemListElement": [ { "@type": "schema:ListItem", "position": 1, "item": { "Field": "Recall number", "Value": "Z-1745-2023", "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": "Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)", "Status": "recorded" } }, { "@type": "schema:ListItem", "position": 6, "item": { "Field": "Reason", "Value": "There is a rare potential for reduced- or no-energy output during high voltage (HV) therapy (typically 0-12J) in implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds) manufactured with a specific (glassed) feedthrough, including currently available ICDs and CRT-Ds.", "Status": "recorded" } }, { "@type": "schema:ListItem", "position": 7, "item": { "Field": "Initiated", "Value": "2023-05-10", "Status": "recorded" } }, { "@type": "schema:ListItem", "position": 8, "item": { "Field": "Lot/code info", "Value": "GTIN 00643169720350, Lot Serial Numbers: BLS604430S, BLS604248S, BLS604229S, BLS604258S, BLS604234S, BLS604223S, BLS604309S, BLS604224S, BLS604227S, BLS604222S, BLS604308S, BLS604256S, BLS604257S, BLS604310S, BLS604313S, BLS604245S, BLS604253S, BLS604252S, BLS604239S, BLS604226S, BLS604371S, BLS604380S, BLS604417S, BLS604419S, BLS604432S, BLS604560S, BLS604562S, BLS604366S, 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BLS604850S, BLS604853S, BLS605111S, BLS605280S, BLS605319S, BLS605379S, BLS605382S, BLS604626S, BLS604627S, BLS604630S, BLS604631S, BLS604714S, BLS604716S, BLS604733S, BLS604734S, BLS604735S, BLS604743S, BLS604744S, BLS604745S, BLS604747S, BLS604748S, BLS604686S, BLS604836S, BLS604907S, BLS604947S, BLS604646S, BLS605154S, BLS605468S, BLS604876S, BLS604917S, BLS604687S, BLS605112S, BLS604465S, BLS604471S, BLS604594S, BLS604595S, BLS604598S, BLS604669S, BLS604670S, BLS604675S, BLS604924S, BLS604982S, BLS605469S, BLS604713S, BLS604723S, BLS604599S, BLS604666S, BLS604668S, BLS604707S, BLS604837S, BLS604838S, BLS604922S, BLS604979S, BLS605335S, BLS605215S, BLS605392S, BLS605489S, BLS604801S, BLS604828S, BLS604829S, BLS604832S, BLS604833S, BLS605159S, BLS605224S, BLS605295S, BLS605302S, BLS605327S, BLS605339S, BLS605402S, BLS605346S, BLS604765S, BLS604767S, BLS604825S, BLS604826S, BLS604827S, BLS604834S, BLS604855S, BLS604856S, BLS604857S, BLS604858S, BLS604859S, BLS604860S, BLS604881S, BLS604901S, BLS604902S, BLS604903S, BLS604948S, BLS604949S, BLS604951S, BLS604952S, BLS605036S, BLS605037S, BLS605104S, BLS605246S, BLS605247S, BLS605288S, BLS605305S, BLS605383S, BLS605397S, BLS605399S, BLS605400S, BLS605476S, BLS605494S, BLS605499S, BLS604469S, BLS604621S, BLS604635S, BLS604941S, BLS605041S, BLS605067S, BLS605083S, BLS605264S, BLS605308S, BLS605386S, BLS605168S, BLS605013S, BLS605068S, BLS605467S, BLS605483S, BLS605182S, BLS605284S, BLS605286S, BLS605478S, BLS604682S, BLS605283S, BLS605201S, BLS605268S, BLS605039S, BLS605117S, BLS605118S, BLS605119S, BLS605249S, BLS605321S, BLS605490S, BLS605491S, BLS605016S, BLS604601S, BLS604660S, BLS604904S, BLS604923S, BLS604926S, BLS604928S, BLS604943S, BLS605271S, BLS605376S, BLS604732S, BLS604799S, BLS605001S, BLS604628S, BLS604661S, BLS604972S, BLS605404S, BLS604880S, BLS605394S, BLS605190S, BLS605454S, BLS605456S, BLS605228S, BLS605279S, BLS605426S, BLS605192S, BLS604936S, BLS604992S, BLS605096S, BLS605105S, BLS605106S, BLS605164S, BLS605165S, BLS605166S, BLS605167S, BLS605289S, BLS605290S, BLS605292S, BLS605293S, BLS605401S, BLS605498S, BLS605278S, BLS605471S, BLS604755S, BLS605393S, BLS605405S, BLS605294S, BLS605345S, BLS605354S, BLS604913S, BLS604641S, BLS604683S, BLS604823S, BLS604824S, BLS604830S, BLS604884S, BLS604885S, BLS604886S, BLS604887S, BLS604888S, BLS604889S, BLS604890S, BLS604891S, BLS604892S, BLS605251S, BLS605266S, BLS605267S, BLS605340S, BLS605341S, BLS605352S, BLS605361S, BLS605029S, BLS605219S, BLS605325S, BLS605326S, BLS605461S, BLS605473S, BLS605218S, BLS604604S, BLS604643S, BLS604724S, BLS604746S, BLS604751S, BLS604752S, BLS604753S, BLS604757S, BLS604774S, BLS604780S, BLS604784S, BLS604785S, BLS604786S, BLS604788S, BLS604789S, BLS604790S, BLS604791S, BLS604792S, BLS604842S, BLS604843S, BLS604845S, BLS604848S, BLS604849S, BLS605020S, BLS605298S, BLS605042S, BLS604653S, BLS604701S, BLS604709S, BLS605306S, BLS605214S, BLS605229S, BLS605333S, BLS605487S, BLS604602S, BLS604618S, BLS604620S, BLS604625S, BLS604629S, BLS604634S, BLS604644S, BLS604673S, BLS604691S, BLS605477S, BLS604671S, BLS604729S, BLS604796S, BLS605127S, BLS605185S, BLS605225S, BLS605226S, BLS605318S, BLS604773S, BLS604775S, BLS604776S, BLS604760S, BLS604794S, BLS604797S, BLS604798S, BLS604851S, BLS604852S, BLS604854S, BLS604861S, BLS604862S, BLS604865S, BLS604867S, BLS604870S, BLS604874S, BLS604875S, BLS604877S, BLS604878S, BLS604883S, BLS604893S, BLS604894S, BLS604895S, BLS604896S, BLS604897S, BLS604898S, BLS604899S, BLS604900S, BLS604905S, BLS604906S, BLS604908S, BLS604910S, BLS604911S, BLS604912S, BLS604914S, BLS604915S, BLS604916S, BLS604918S, BLS604920S, BLS604921S, BLS604925S, BLS604927S, BLS604929S, BLS604931S, BLS604932S, BLS604933S, BLS604934S, BLS604935S, BLS604937S, BLS604938S, BLS604939S, BLS604940S, BLS604942S, BLS604944S, BLS604945S, BLS604953S, BLS604954S, BLS604955S, BLS604956S, BLS604957S, BLS604958S, BLS604964S, BLS604965S, BLS604966S, BLS604967S, BLS604968S, BLS604969S, BLS604970S, BLS604971S, BLS604973S, BLS604974S, BLS604975S, BLS604976S, BLS604977S, BLS604978S, BLS604981S, BLS604983S, BLS604984S, BLS604985S, BLS604986S, BLS604987S, BLS604988S, BLS604989S, BLS604990S, BLS604991S, BLS604993S, BLS604994S, BLS604995S, BLS604996S, BLS604997S, BLS604998S, BLS605000S, BLS605002S, BLS605003S, BLS605004S, BLS605005S, BLS605006S, BLS605007S, BLS605008S, BLS605009S, BLS605010S, BLS605011S, BLS605012S, BLS605015S, BLS605018S, BLS605019S, BLS605021S, BLS605022S, BLS605023S, BLS605024S, BLS605025S, BLS605026S, BLS605027S, BLS605028S, BLS605030S, BLS605031S, BLS605032S, BLS605033S, BLS605034S, BLS605035S, BLS605040S, BLS605043S, BLS605044S, BLS605045S, BLS605046S, BLS605047S, BLS605049S, BLS605055S, BLS605062S, BLS605063S, BLS605066S, BLS605069S, BLS605071S, BLS605072S, BLS605073S, BLS605076S, BLS605082S, BLS605085S, BLS605087S, BLS605088S, BLS605089S, BLS605091S, BLS605092S, BLS605095S, BLS605097S, BLS605098S, BLS605099S, BLS605100S, BLS605101S, BLS605102S, BLS605107S, BLS605108S, BLS605109S, BLS605110S, BLS605114S, BLS605115S, BLS605116S, BLS605120S, BLS605121S, BLS605122S, BLS605123S, BLS605124S, BLS605125S, BLS605126S, BLS605129S, BLS605130S, BLS605139S, BLS605140S, BLS605141S, BLS605142S, BLS605143S, BLS605144S, BLS605145S, BLS605146S, BLS605147S, BLS605148S, BLS605149S, BLS605150S, BLS605158S, BLS605160S, BLS605161S, BLS605162S, BLS605176S, BLS605177S, BLS605178S, BLS605179S, BLS605183S, BLS605184S, BLS605370S, BLS605221S, BLS605300S, BLS605301S, BLS605330S, BLS605287S, BLS605291S, BLS605357S, BLS605362S, BLS605363S, BLS605364S, BLS605377S; GTIN 00763000612276, Lot Serial Numbers: BLS605515S, BLS605514S, BLS605508S, BLS605509S, BLS605507S", "Status": "recorded" } }, { "@type": "schema:ListItem", "position": 9, "item": { "Field": "Distribution pattern", "Value": "US Nationwide - Worldwide Distribution", "Status": "recorded" } } ] } ] }