{ "@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-1738-2023.jsonld", "@type": "schema:Dataset", "name": "CRT-D DTBA2Q1 VIVA QUAD XT IS4/DF1 INTL, Model Number DTBA2Q1; Implantable Cardioverter Defibrillators", "description": "FDA recall Z-1738-2023 — Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) is recalling CRT-D DTBA2Q1 VIVA QUAD XT IS4/DF1 INTL, Model Number DTBA2Q1; 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-1738-2023&lang=eng", "about": { "@type": "schema:MedicalDevice", "name": "CRT-D DTBA2Q1 VIVA QUAD XT IS4/DF1 INTL, Model Number DTBA2Q1; 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-1738-2023/enforcement-record", "@type": "schema:Claim", "name": "FDA recall Z-1738-2023: Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) is recalling CRT-D DTBA2Q1 VIVA QUAD XT IS4/DF1 INTL, Model Number DTBA2Q1; Implantable Cardioverter Defibrillators", "text": "The FDA logged enforcement record Z-1738-2023: Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) is voluntarily recalling CRT-D DTBA2Q1 VIVA QUAD XT IS4/DF1 INTL, Model Number DTBA2Q1; 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 00643169400603, Lot Serial Numbers: BLH605909S, BLH605759S, BLH605781S, BLH605675S, BLH605010S, BLH605692S, BLH605674S, BLH605156S, BLH605237S, BLH605376S, BLH605837S, BLH605887S, BLH605736S, BLH605691S, BLH605953S, BLH604859S, BLH605700S, BLH605904S, BLH605933S, BLH605945S, BLH605854S, BLH605929S, BLH605742S, BLH605709S, BLH605877S, BLH605786S, BLH605711S, BLH605574S, BLH605747S, BLH605932S, BLH604888S, BLH605014S, BLH605399S, BLH605699S, BLH605705S, BLH605729S, BLH605732S, BLH605806S, BLH605239S, BLH605233S, BLH605704S, BLH605730S, BLH605821S, BLH605400S, BLH605011S, BLH605850S, BLH605707S, BLH605241S, BLH605819S, BLH605820S, BLH605577S, BLH605235S, BLH604907S, BLH605676S, BLH605915S, BLH605319S, BLH605582S, BLH605391S, BLH605519S, BLH605589S, BLH605741S, BLH604904S, BLH605738S, BLH605835S, BLH605845S, BLH605846S, BLH605823S, BLH604886S, BLH605151S, BLH605398S, BLH605702S, BLH605591S, BLH605394S, BLH605672S, BLH605726S, BLH605581S, BLH605790S, BLH605397S, BLH605791S, BLH605690S, BLH605708S, BLH604902S, BLH605157S, BLH605733S, BLH605861S, BLH605584S, BLH605746S, BLH605145S, BLH604878S, BLH605719S, BLH605232S, BLH605269S, BLH605826S, BLH605737S, BLH605871S, BLH605373S, BLH605739S, BLH605388S, BLH605585S, BLH605587S, BLH605780S, BLH605728S, BLH604894S, BLH605782S, BLH605706S, BLH604879S, BLH605701S, BLH605694S, BLH605758S, BLH605012S, BLH605393S, BLH605696S, BLH605940S, BLH605695S, BLH604893S, BLH605753S; GTIN 00643169720220, Lot Serial Numbers: BLH605473S, BLH604935S, BLH604937S, BLH605016S, BLH605076S, BLH605078S, BLH605180S, BLH605210S, BLH605230S, BLH605297S, BLH605462S, BLH605687S, BLH604836S, BLH604858S, BLH604861S, BLH604885S, BLH604909S, BLH604915S, BLH604927S, BLH604933S, BLH604951S, BLH605678S, BLH604853S, BLH605298S, BLH604925S, BLH605683S, BLH604839S, BLH604874S, BLH604910S, BLH604845S, BLH605009S, BLH604963S, BLH604964S, BLH604837S, BLH604940S, BLH604945S, BLH604865S, BLH604844S, BLH604870S, BLH604849S, BLH604911S, BLH604877S, BLH604918S, BLH604860S, BLH605684S, BLH604843S, BLH605679S, BLH604842S, BLH604852S, BLH605015S, BLH604854S, BLH605172S, BLH605173S, BLH605174S, BLH605175S, BLH605176S, BLH605177S, BLH605178S, BLH605179S, BLH605181S, BLH605182S, BLH605183S, BLH605185S, BLH605187S, BLH605188S, BLH605190S, BLH605203S, BLH605204S, BLH605205S, BLH605208S, BLH605209S, BLH605213S, BLH605217S, BLH605224S, BLH605225S, BLH605226S, BLH605228S, BLH605262S, BLH605292S, BLH605294S, BLH605296S, BLH605299S, BLH605300S, BLH605301S, BLH605302S, BLH605303S, BLH605304S, BLH605307S, BLH605309S, BLH605310S, BLH605311S, BLH605313S, BLH605314S, BLH605517S, BLH605685S, BLH605686S, BLH604884S, BLH605053S, BLH605054S, BLH605055S, BLH605056S, BLH604840S, BLH604862S, BLH604912S, BLH604914S, BLH604921S, BLH604922S, BLH604833S, BLH604881S, BLH604961S, BLH604942S, BLH604896S, BLH604903S, BLH604998S, BLH605148S, BLH605323S, BLH605328S, BLH605330S, BLH605377S, BLH605378S, BLH605381S, BLH605409S, BLH605456S, BLH605467S, BLH605468S, BLH605483S, BLH605490S, BLH605520S, BLH605557S, BLH604973S, BLH604974S, BLH604975S, BLH604977S, BLH604980S, BLH604992S, BLH605003S, BLH605007S, BLH605068S, BLH605127S, BLH605128S, BLH605132S, BLH605144S, BLH605195S, BLH605198S, BLH605270S, BLH605277S, BLH605325S, BLH605338S, BLH605340S, BLH605357S, BLH605380S, BLH605404S, BLH605410S, BLH605425S, BLH605136S, BLH605335S, BLH605407S, BLH605445S, BLH605488S, BLH605168S, BLH605169S, BLH605280S, BLH604882S, BLH604970S, BLH604990S, BLH604999S, BLH605073S, BLH605108S, BLH605123S, BLH605405S, BLH604996S, BLH605040S, BLH605116S, BLH605119S, BLH605129S, BLH604871S, BLH604924S, BLH604955S, BLH604985S, BLH605114S, BLH605115S, BLH605153S, BLH605326S, BLH605341S, BLH605347S, BLH605349S, BLH605351S, BLH605355S, BLH605386S, BLH605390S, BLH605440S, BLH605446S, BLH605457S, BLH605442S, BLH605466S, BLH605491S, BLH605125S, BLH604993S, BLH605143S, BLH605147S, BLH605164S, BLH605267S, BLH605271S, BLH605281S, BLH605337S, BLH605354S, BLH605368S, BLH605369S, BLH605371S, BLH605384S, BLH605387S, BLH605430S, BLH605443S, BLH605447S, BLH605451S, BLH605479S, BLH605512S, BLH605513S, BLH605514S, BLH604887S, BLH605069S, BLH605126S, BLH605452S, BLH605552S, BLH604721S, BLH604892S, BLH604905S, BLH604936S, BLH605000S, BLH605110S, BLH605202S, BLH605360S, BLH605422S, BLH605428S, BLH605453S, BLH605555S, BLH605120S, BLH605279S, BLH605423S, BLH604899S, BLH604994S, BLH605113S, BLH605329S, BLH605406S, BLH605426S, BLH605427S, BLH605455S, BLH605458S, BLH605484S, BLH605559S, BLH605111S, BLH605112S, BLH605162S, BLH605194S, BLH605465S, BLH605067S, BLH605124S, BLH605343S, BLH605344S, BLH605435S, BLH605459S, BLH605471S, BLH605352S, BLH605372S, BLH605411S, BLH605439S, BLH604986S, BLH605130S, BLH605167S, BLH605184S, BLH605200S, BLH605098S, BLH605099S, BLH605100S, BLH605101S, BLH605102S, BLH605103S, BLH605104S, BLH605105S, BLH605106S, BLH605107S, BLH605146S, BLH605192S, BLH605193S, BLH604890S, BLH604952S, BLH604972S, BLH604995S, BLH605066S, BLH605118S, BLH605133S, BLH605134S, BLH605196S, BLH605322S, BLH605324S, BLH605359S, BLH605401S, BLH605553S, BLH604857S, BLH604901S, BLH604906S, BLH604987S, BLH604989S, BLH605002S, BLH605008S, BLH605121S, BLH605274S, BLH604700S, BLH604891S, BLH604997S, BLH605070S, BLH605075S, BLH605201S, BLH605218S, BLH605333S, BLH605362S, BLH605474S, BLH605554S, BLH604699S, BLH604869S, BLH604965S, BLH605071S, BLH605308S, BLH605312S, BLH605315S, BLH605320S, BLH605321S, BLH605342S, BLH605356S, BLH605358S, BLH605516S, BLH605211S, BLH605276S, BLH605005S, BLH605006S, BLH605097S, BLH605109S, BLH605137S, BLH605141S, BLH605273S, BLH605348S, BLH605363S, BLH605370S, BLH605374S, BLH605379S, BLH605382S, BLH605383S, BLH605385S, BLH605433S, BLH605436S, BLH605437S, BLH605438S, BLH605444S, BLH605475S, BLH605486S, BLH605515S, BLH605558S, BLH604934S, BLH604956S, BLH604971S, BLH604991S, BLH605001S, BLH605074S, BLH605122S, BLH605131S, BLH605135S, BLH605150S, BLH605165S, BLH605166S, BLH605197S, BLH605223S, BLH605231S, BLH605268S, BLH605272S, BLH605275S, BLH605295S, BLH605327S, BLH605364S, BLH605396S, BLH605424S, BLH605485S, BLH605487S, BLH605159S, BLH605161S, BLH605219S, BLH605350S, BLH605361S, BLH605366S, BLH605375S, BLH605441S, BLH605461S, BLH605480S, BLH604838S, BLH604959S, BLH604880S, BLH605316S, BLH605278S, BLH605680S, BLH604868S, BLH604988S, BLH604835S, BLH605004S, BLH604889S, BLH605214S, BLH605478S, BLH605215S, BLH605318S, BLH604944S, BLH604947S, BLH604957S, BLH605065S, BLH605229S, BLH605332S, BLH605334S, BLH605336S, BLH605346S, BLH605403S, BLH605432S, BLH605448S, BLH605449S, BLH605454S, BLH605477S, BLH605518S, BLH605560S, BLH605562S, BLH605563S, BLH605564S, BLH605305S, BLH605117S, BLH605345S, BLH605212S, BLH604939S, BLH605207S; GTIN 00643169980174, Lot Serial Numbers: BLH606507S, BLH606527S, BLH606561S, BLH606472S, BLH606476S, BLH606473S, BLH606477S, BLH605833S, BLH605927S, BLH605528S, BLH605839S, BLH605905S, BLH605140S, BLH605287S, BLH605504S, BLH605525S, BLH605531S, BLH605532S, BLH605623S, BLH605284S, BLH605289S, BLH605420S, BLH605626S, BLH605524S, BLH605533S, BLH605139S, BLH606369S, BLH606221S, BLH606391S, BLH606467S, BLH606469S, BLH605628S, BLH605848S, BLH605965S, BLH606025S, BLH605616S, BLH605889S, BLH606182S, BLH605282S, BLH605290S, BLH605413S, BLH605419S, BLH605522S, BLH605529S, BLH605530S, BLH605539S, BLH605540S, BLH605545S, BLH605549S, BLH605778S, BLH605817S, BLH605822S, BLH605853S, BLH605859S, BLH605870S, BLH605876S, BLH605879S, BLH605890S, BLH605895S, BLH605898S, BLH605910S, BLH605911S, BLH605912S, BLH605913S, BLH605914S, BLH605920S, BLH605921S, BLH605924S, BLH605925S, BLH605926S, BLH605928S, BLH605966S, BLH605972S, BLH605982S, BLH605987S, BLH605999S, BLH606004S, BLH606007S, BLH606017S, BLH606023S, BLH606027S, BLH606136S, BLH606137S, BLH606139S, BLH606140S, BLH606143S, BLH606145S, BLH606146S, BLH606149S, BLH606150S, BLH606151S, BLH606165S, BLH606167S, BLH606179S, BLH606188S, BLH606189S, BLH606191S, BLH606197S, BLH606202S, BLH606203S, BLH606206S, BLH606212S, BLH606216S, BLH606217S, BLH606226S, BLH606227S, BLH606232S, BLH606238S, BLH606240S, BLH606305S, BLH606307S, BLH606308S, BLH606314S, BLH606315S, BLH606317S, BLH606318S, BLH606322S, BLH606328S, BLH606338S, BLH606341S, BLH606357S, BLH606360S, BLH606362S, BLH606363S, BLH606364S, BLH606365S, BLH606367S, BLH606368S, BLH606372S, BLH606376S, BLH606381S, BLH606386S, BLH606398S, BLH606401S, BLH606403S, BLH606404S, BLH606406S, BLH606407S, BLH606408S, BLH606409S, BLH606410S, BLH606411S, BLH606414S, BLH606415S, BLH606416S, BLH606417S, BLH606418S, BLH606420S, BLH606423S, BLH606424S, BLH606425S, BLH606427S, BLH606428S, BLH606443S, BLH606445S, BLH606446S, BLH606448S, BLH606451S, BLH606452S, BLH606453S, BLH606456S, BLH606461S, BLH606462S, BLH606470S, BLH606471S, BLH606474S, BLH606475S, BLH606479S, BLH606487S, BLH605838S, BLH606018S, BLH606144S, BLH606187S, BLH606375S, BLH606402S, BLH605283S, BLH605286S, BLH605288S, BLH605523S, BLH605547S, BLH605550S, BLH605631S, BLH605843S, BLH606001S, BLH606021S, BLH606201S, BLH606321S, BLH606332S, BLH606334S, BLH606359S, BLH606373S, BLH606405S, BLH606464S, BLH606481S, BLH606483S, BLH605285S, BLH605538S, BLH605619S, BLH606358S, BLH605977S, BLH605880S, BLH606204S, BLH606374S, BLH606310S, BLH606029S, BLH605602S, BLH605612S, BLH605865S, BLH605541S, BLH605544S, BLH605527S, BLH605629S, BLH605421S, BLH605492S, BLH605493S, BLH605494S, BLH605495S, BLH605496S, BLH605497S, BLH605498S, BLH605499S, BLH605500S, BLH605501S, BLH605502S, BLH605505S, BLH605506S, BLH605507S, BLH605508S, BLH605509S, BLH605510S, BLH605511S, BLH605542S, BLH605543S, BLH605593S, BLH605594S, BLH605630S, BLH605825S, BLH605828S, BLH606231S, BLH606361S, BLH605922S, BLH606019S, BLH606022S, BLH606036S, BLH606337S, BLH606422S, BLH605632S, BLH605660S, BLH605667S, BLH605789S, BLH605670S, BLH605749S, BLH605771S, BLH605793S, BLH605830S, BLH605967S, BLH605983S, BLH606032S, BLH606132S, BLH606166S, BLH606327S, BLH606335S, BLH605661S, BLH605734S, BLH605764S, BLH605775S, BLH605779S, BLH605815S, BLH605824S, BLH605847S, BLH605990S, BLH606147S, BLH606153S, BLH606171S, BLH605647S, BLH605657S, BLH605665S, BLH605745S, BLH605776S, BLH605792S, BLH605836S, BLH605997S, BLH606161S, BLH606399S, BLH605637S, BLH605748S, BLH605751S, BLH605765S, BLH605785S, BLH605813S, BLH605858S, BLH605872S, BLH605959S, BLH605973S, BLH605974S, BLH605992S, BLH606164S, BLH606184S, BLH606193S, BLH606194S, BLH606195S, BLH606208S, BLH606210S, BLH606234S, BLH606236S, BLH606306S, BLH606342S, BLH606380S, BLH606396S, BLH606421S, BLH606444S, BLH606449S, BLH605651S, BLH605659S, BLH605919S, BLH605947S, BLH605962S, BLH605984S, BLH606014S, BLH606026S, BLH606028S, BLH606154S, BLH606159S, BLH606169S, BLH606190S, BLH606224S, BLH606228S, BLH606235S, BLH606237S, BLH606323S, BLH606324S, BLH606326S, BLH606329S, BLH606343S, BLH606390S, BLH605633S, BLH605634S, BLH605636S, BLH605638S, BLH605639S, BLH605653S, BLH605768S, BLH605827S, BLH605960S, BLH605961S, BLH605976S, BLH605985S, BLH605988S, BLH605994S, BLH605995S, BLH606011S, BLH606020S, BLH606177S, BLH606180S, BLH606192S, BLH606209S, BLH606316S, BLH606331S, BLH606383S, BLH606392S, BLH606393S, BLH606394S, BLH606514S, BLH606520S, BLH605757S, BLH605635S, BLH605664S, BLH605668S, BLH605901S, BLH605952S, BLH605955S, BLH605964S, BLH606172S, BLH606223S, BLH605656S, BLH605666S, BLH605867S, BLH605903S, BLH605907S, BLH605956S, BLH606003S, BLH606134S, BLH606155S, BLH606213S, BLH606431S, BLH606432S, BLH606433S, BLH606435S, BLH605860S, BLH605662S, BLH605795S, BLH605900S, BLH605906S, BLH605975S, BLH605770S, BLH605646S, BLH605812S, BLH605971S, BLH605979S, BLH605991S, BLH606015S, BLH606138S, BLH606211S, BLH606330S, BLH606333S, BLH606378S, BLH606387S, BLH606429S, BLH606441S, BLH606515S, BLH605727S, BLH605772S, BLH605773S, BLH605774S, BLH605818S, BLH605963S, BLH606009S, BLH606173S, BLH606198S, BLH606304S, BLH606437S, BLH606442S, BLH606498S, BLH605642S, BLH605649S, BLH605652S, BLH605720S, BLH605722S, BLH606013S, BLH606034S, BLH606156S, BLH606157S, BLH606196S, BLH606199S, BLH606320S, BLH606497S, BLH605641S, BLH605663S, BLH605763S, BLH605799S, BLH605885S, BLH605886S, BLH605891S, BLH605948S, BLH605640S, BLH605643S, BLH605648S, BLH605655S, BLH605788S, BLH605842S, BLH605958S, BLH605970S, BLH606219S, BLH606230S, BLH606377S, BLH605644S, BLH605882S, BLH605899S, BLH605989S, BLH605993S, BLH606339S, BLH605418S, BLH605998S, BLH606158S, BLH606176S, BLH606205S, BLH606225S, BLH606388S, BLH606412S, BLH606436S, BLH606447S, BLH606455S, BLH606521S, BLH606459S, BLH605414S, BLH606168S, BLH606035S, BLH606005S, BLH606385S, BLH606413S, BLH605834S, BLH606010S, BLH606430S, BLH606454S, BLH605526S, BLH605620S, BLH605621S, BLH605622S, BLH605892S, BLH605893S, BLH605894S, BLH605978S, BLH606030S, BLH606133S, BLH606135S, BLH606141S, BLH606163S, BLH606178S, BLH606319S, BLH606457S, BLH605415S, BLH605750S, BLH605752S, BLH605754S, BLH605769S, BLH605808S, BLH605986S, BLH606000S, BLH606008S, BLH606016S, BLH606152S, BLH606160S, BLH606170S, BLH605592S, BLH605613S, BLH605615S, BLH605618S, BLH605624S, BLH605841S, 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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-1738-2023&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-1738-2023&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-1738-2023/fda-classification", "@type": "schema:Claim", "name": "FDA classified recall Z-1738-2023 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-1738-2023&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-1738-2023&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-1738-2023/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-1738-2023", "numberOfItems": 9, "itemListElement": [ { "@type": "schema:ListItem", "position": 1, "item": { "Field": "Recall number", "Value": "Z-1738-2023", "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 00643169400603, Lot Serial Numbers: BLH605909S, BLH605759S, BLH605781S, BLH605675S, BLH605010S, BLH605692S, BLH605674S, BLH605156S, BLH605237S, BLH605376S, BLH605837S, BLH605887S, BLH605736S, BLH605691S, BLH605953S, BLH604859S, BLH605700S, BLH605904S, BLH605933S, BLH605945S, BLH605854S, BLH605929S, BLH605742S, BLH605709S, BLH605877S, BLH605786S, BLH605711S, BLH605574S, 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BLH606407S, BLH606408S, BLH606409S, BLH606410S, BLH606411S, BLH606414S, BLH606415S, BLH606416S, BLH606417S, BLH606418S, BLH606420S, BLH606423S, BLH606424S, BLH606425S, BLH606427S, BLH606428S, BLH606443S, BLH606445S, BLH606446S, BLH606448S, BLH606451S, BLH606452S, BLH606453S, BLH606456S, BLH606461S, BLH606462S, BLH606470S, BLH606471S, BLH606474S, BLH606475S, BLH606479S, BLH606487S, BLH605838S, BLH606018S, BLH606144S, BLH606187S, BLH606375S, BLH606402S, BLH605283S, BLH605286S, BLH605288S, BLH605523S, BLH605547S, BLH605550S, BLH605631S, BLH605843S, BLH606001S, BLH606021S, BLH606201S, BLH606321S, BLH606332S, BLH606334S, BLH606359S, BLH606373S, BLH606405S, BLH606464S, BLH606481S, BLH606483S, BLH605285S, BLH605538S, BLH605619S, BLH606358S, BLH605977S, BLH605880S, BLH606204S, BLH606374S, BLH606310S, BLH606029S, BLH605602S, BLH605612S, BLH605865S, BLH605541S, BLH605544S, BLH605527S, BLH605629S, BLH605421S, BLH605492S, BLH605493S, BLH605494S, BLH605495S, BLH605496S, BLH605497S, BLH605498S, BLH605499S, BLH605500S, BLH605501S, BLH605502S, BLH605505S, BLH605506S, BLH605507S, BLH605508S, BLH605509S, BLH605510S, BLH605511S, BLH605542S, BLH605543S, BLH605593S, BLH605594S, BLH605630S, BLH605825S, BLH605828S, BLH606231S, BLH606361S, BLH605922S, BLH606019S, BLH606022S, BLH606036S, BLH606337S, BLH606422S, BLH605632S, BLH605660S, BLH605667S, BLH605789S, BLH605670S, BLH605749S, BLH605771S, BLH605793S, BLH605830S, BLH605967S, BLH605983S, BLH606032S, BLH606132S, BLH606166S, BLH606327S, BLH606335S, BLH605661S, BLH605734S, BLH605764S, BLH605775S, BLH605779S, BLH605815S, BLH605824S, BLH605847S, BLH605990S, BLH606147S, BLH606153S, BLH606171S, BLH605647S, BLH605657S, BLH605665S, BLH605745S, BLH605776S, BLH605792S, BLH605836S, BLH605997S, BLH606161S, BLH606399S, BLH605637S, BLH605748S, BLH605751S, BLH605765S, BLH605785S, BLH605813S, BLH605858S, BLH605872S, BLH605959S, BLH605973S, BLH605974S, BLH605992S, BLH606164S, BLH606184S, BLH606193S, BLH606194S, BLH606195S, BLH606208S, BLH606210S, BLH606234S, BLH606236S, BLH606306S, BLH606342S, BLH606380S, BLH606396S, BLH606421S, BLH606444S, BLH606449S, BLH605651S, BLH605659S, BLH605919S, BLH605947S, BLH605962S, BLH605984S, BLH606014S, BLH606026S, BLH606028S, BLH606154S, BLH606159S, BLH606169S, BLH606190S, BLH606224S, BLH606228S, BLH606235S, BLH606237S, BLH606323S, BLH606324S, BLH606326S, BLH606329S, BLH606343S, BLH606390S, BLH605633S, BLH605634S, BLH605636S, BLH605638S, BLH605639S, BLH605653S, BLH605768S, BLH605827S, BLH605960S, BLH605961S, BLH605976S, BLH605985S, BLH605988S, BLH605994S, BLH605995S, BLH606011S, BLH606020S, BLH606177S, BLH606180S, BLH606192S, BLH606209S, BLH606316S, BLH606331S, BLH606383S, BLH606392S, BLH606393S, BLH606394S, BLH606514S, BLH606520S, BLH605757S, BLH605635S, BLH605664S, BLH605668S, BLH605901S, BLH605952S, BLH605955S, BLH605964S, BLH606172S, BLH606223S, BLH605656S, BLH605666S, BLH605867S, BLH605903S, BLH605907S, BLH605956S, BLH606003S, BLH606134S, BLH606155S, BLH606213S, BLH606431S, BLH606432S, BLH606433S, BLH606435S, BLH605860S, BLH605662S, BLH605795S, BLH605900S, BLH605906S, BLH605975S, BLH605770S, BLH605646S, BLH605812S, BLH605971S, BLH605979S, BLH605991S, BLH606015S, BLH606138S, BLH606211S, BLH606330S, BLH606333S, BLH606378S, BLH606387S, BLH606429S, BLH606441S, BLH606515S, BLH605727S, BLH605772S, BLH605773S, BLH605774S, BLH605818S, BLH605963S, BLH606009S, BLH606173S, BLH606198S, BLH606304S, BLH606437S, BLH606442S, BLH606498S, BLH605642S, BLH605649S, BLH605652S, BLH605720S, BLH605722S, BLH606013S, BLH606034S, BLH606156S, BLH606157S, BLH606196S, BLH606199S, BLH606320S, BLH606497S, BLH605641S, BLH605663S, BLH605763S, BLH605799S, BLH605885S, BLH605886S, BLH605891S, BLH605948S, BLH605640S, BLH605643S, BLH605648S, BLH605655S, BLH605788S, BLH605842S, BLH605958S, BLH605970S, BLH606219S, BLH606230S, BLH606377S, BLH605644S, BLH605882S, BLH605899S, BLH605989S, BLH605993S, BLH606339S, BLH605418S, BLH605998S, BLH606158S, BLH606176S, BLH606205S, BLH606225S, BLH606388S, BLH606412S, BLH606436S, BLH606447S, BLH606455S, BLH606521S, BLH606459S, BLH605414S, BLH606168S, BLH606035S, BLH606005S, BLH606385S, BLH606413S, BLH605834S, BLH606010S, BLH606430S, BLH606454S, BLH605526S, BLH605620S, BLH605621S, BLH605622S, BLH605892S, BLH605893S, BLH605894S, BLH605978S, BLH606030S, BLH606133S, BLH606135S, BLH606141S, BLH606163S, BLH606178S, BLH606319S, BLH606457S, BLH605415S, BLH605750S, BLH605752S, BLH605754S, BLH605769S, BLH605808S, BLH605986S, BLH606000S, BLH606008S, BLH606016S, BLH606152S, BLH606160S, BLH606170S, BLH605592S, BLH605613S, BLH605615S, BLH605618S, BLH605624S, BLH605841S, BLH605874S, BLH605968S, BLH606031S, BLH606174S, BLH606200S, BLH606220S, BLH605614S, BLH605800S, BLH605803S, BLH605902S, BLH606002S, BLH606148S, BLH605654S, BLH605794S, BLH605721S, BLH606312S, BLH605417S, BLH606229S, BLH606239S, BLH605534S, BLH606325S, BLH606434S, BLH605724S, BLH605725S, BLH605535S, BLH606336S, BLH605537S, BLH606371S, BLH606379S, BLH606384S, BLH606389S, BLH606400S, BLH606419S, BLH606426S, BLH606450S, BLH606458S, BLH606460S, BLH606463S, BLH606468S, BLH606478S, BLH606480S, BLH606482S, BLH606484S, BLH606486S, BLH606488S, BLH606493S, BLH606494S, BLH606499S, BLH606500S, BLH606501S, BLH606502S, BLH606503S, BLH606504S, BLH606505S, BLH606506S, BLH606508S, BLH606517S, BLH606518S, BLH606524S, BLH606525S, BLH606528S, BLH606559S, BLH606560S, BLH606529S", "Status": "recorded" } }, { "@type": "schema:ListItem", "position": 9, "item": { "Field": "Distribution pattern", "Value": "US Nationwide - Worldwide Distribution", "Status": "recorded" } } ] } ] }