{ "@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-1733-2023.jsonld", "@type": "schema:Dataset", "name": "CRT-D DTBA1QQ VIVA QUAD XT IS4/DF4 US, Model Number DTBA1QQ; Implantable Cardioverter Defibrillators", "description": "FDA recall Z-1733-2023 — Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) is recalling CRT-D DTBA1QQ VIVA QUAD XT IS4/DF4 US, Model Number DTBA1QQ; 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-1733-2023&lang=eng", "about": { "@type": "schema:MedicalDevice", "name": "CRT-D DTBA1QQ VIVA QUAD XT IS4/DF4 US, Model Number DTBA1QQ; 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-1733-2023/enforcement-record", "@type": "schema:Claim", "name": "FDA recall Z-1733-2023: Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) is recalling CRT-D DTBA1QQ VIVA QUAD XT IS4/DF4 US, Model Number DTBA1QQ; Implantable Cardioverter Defibrillators", "text": "The FDA logged enforcement record Z-1733-2023: Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) is voluntarily recalling CRT-D DTBA1QQ VIVA QUAD XT IS4/DF4 US, Model Number DTBA1QQ; 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 00643169720138, Lot Serial Numbers: BLC228471H, BLC228476H, BLC228533H, BLC228541H, BLC228635H, BLC228702H, BLC228745H, BLC228827H, BLC228830H, BLC228840H, BLC228872H, BLC227820H, BLC228658H, BLC228889H, BLC228890H, BLC228895H, BLC228896H, BLC228900H, BLC228350H, BLC228567H, BLC228738H, BLC229053H, BLC229197H, BLC229064H, BLC228295H, BLC228587H, BLC228382H, BLC228585H, BLC228296H, BLC228583H, BLC228787H, BLC228926H, BLC229106H, BLC228579H, BLC228245H, BLC228551H, BLC228625H, BLC228819H, BLC228440H, BLC228622H, BLC228825H, BLC228456H, BLC228432H, BLC228960H, BLC229166H, BLC228545H, BLC228676H, BLC228695H, BLC228573H, BLC229089H, BLC228721H, BLC228898H, BLC228980H, BLC229099H, BLC228302H, BLC228256H, BLC228258H, BLC228300H, BLC228319H, BLC228355H, BLC228394H, BLC228406H, BLC228450H, BLC228461H, BLC228515H, BLC228309H, BLC228379H, BLC228491H, BLC228510H, BLC228511H, BLC228577H, BLC228707H, BLC228800H, BLC228861H, BLC229110H, BLC229192H, BLC229207H, BLC229107H, BLC228228H, BLC228312H, BLC229032H, BLC229062H, BLC229094H, BLC229161H, BLC229169H, BLC229210H, BLC228653H, BLC228685H, BLC228409H, BLC229144H, BLC228581H, BLC228940H, BLC229154H, BLC228580H, BLC228509H, BLC228593H, BLC228614H, BLC229219H, BLC228386H, BLC228466H, BLC228810H, BLC228235H, BLC228428H, BLC228462H, BLC228463H, BLC228464H, BLC228470H, BLC228485H, BLC228488H, BLC228492H, BLC228493H, BLC228495H, BLC228497H, BLC228502H, BLC228504H, BLC228508H, BLC228985H, BLC228986H, BLC228987H, BLC228999H, BLC229000H, BLC229001H, BLC229003H, BLC229131H, BLC229132H, BLC229133H, BLC229212H, BLC228970H, BLC228641H, BLC228769H, BLC228324H, BLC228562H, BLC228610H, BLC228619H, BLC228505H, BLC228547H, BLC228589H, BLC228469H, BLC228559H, BLC228571H, BLC228774H, BLC228977H, BLC228984H, BLC229088H, BLC229093H, BLC229111H, BLC229191H, BLC229100H, BLC228403H, BLC228483H, BLC228399H, BLC228402H, BLC228768H, BLC228942H, BLC228574H, BLC228842H, BLC228538H, BLC228568H, BLC228906H, BLC229118H, BLC228654H, BLC229123H, BLC228250H, BLC228305H, BLC228348H, BLC228396H, BLC228475H, BLC228503H, BLC228566H, BLC228592H, BLC228965H, BLC228976H, BLC229033H, BLC228356H, BLC228482H, BLC228916H, BLC229036H, BLC228365H, BLC228546H, BLC228272H, BLC228273H, BLC228276H, BLC228280H, BLC228289H, BLC228290H, BLC228307H, BLC228338H, BLC228354H, BLC228359H, BLC228367H, BLC228368H, BLC228417H, BLC228420H, BLC228427H, BLC228444H, BLC228452H, BLC228467H, BLC228486H, BLC228501H, BLC228523H, BLC228525H, BLC228526H, BLC228532H, BLC228536H, BLC228550H, BLC228555H, BLC228611H, BLC228627H, BLC228876H, BLC228882H, BLC228884H, BLC228901H, BLC228911H, BLC228928H, BLC228935H, BLC228958H, BLC228963H, BLC228967H, BLC228969H, BLC228990H, BLC228991H, BLC228992H, BLC229002H, BLC229006H, BLC229007H, BLC229019H, BLC229023H, BLC229027H, BLC229030H, BLC229048H, BLC229049H, BLC229050H, BLC229055H, BLC229056H, BLC229079H, BLC229084H, BLC229113H, BLC229136H, BLC229137H, BLC229138H, BLC229139H, BLC229140H, BLC229141H, BLC229146H, BLC229152H, BLC229163H, BLC229167H, BLC229171H, BLC229173H, BLC229174H, BLC229175H, BLC228982H, BLC228448H, BLC228293H, BLC228794H, BLC228468H, BLC228252H, BLC228457H, BLC228487H, BLC228724H, BLC228939H, BLC228952H, BLC228836H, BLC228938H, BLC228972H, BLC228242H, BLC228292H, BLC228287H, BLC228374H, BLC228288H, BLC228291H, BLC228378H, BLC228398H, BLC228643H, BLC228795H, BLC228943H, BLC229195H, BLC228282H, BLC228500H, BLC228244H, BLC228656H, BLC228357H, BLC229129H, BLC228408H, BLC228405H, BLC228788H, BLC228313H, BLC228322H, BLC228517H, BLC228650H, BLC228848H, BLC228308H, BLC228347H, BLC228426H, BLC228480H, BLC228781H, BLC228905H, BLC228918H, BLC228921H, BLC229061H, BLC229087H, BLC229102H, BLC229157H, BLC229200H, BLC228799H, BLC228460H, BLC229156H, BLC228237H, BLC228316H, BLC228419H, BLC228596H, BLC228662H, BLC228779H, BLC228885H, BLC228902H, BLC229017H, BLC229120H, BLC229189H, BLC228598H, BLC228311H, BLC228436H, BLC228703H, BLC228973H, BLC228337H, BLC228220H, BLC228221H, BLC228223H, BLC228232H, BLC228241H, BLC228342H, BLC228344H, BLC228369H, BLC228375H, BLC228425H, BLC228496H, BLC228597H, BLC228639H, BLC228655H, BLC228663H, BLC228664H, BLC228671H, BLC228679H, BLC228688H, BLC228722H, BLC228730H, BLC228734H, BLC228736H, BLC228750H, BLC228786H, BLC228790H, BLC228829H, BLC228833H, BLC228880H, BLC228893H, BLC228897H, BLC228927H, BLC228931H, BLC228947H, BLC228981H, BLC228983H, BLC229016H, BLC229039H, BLC229072H, BLC229075H, BLC229109H, BLC229119H, BLC229121H, BLC229125H, BLC229177H, BLC229181H, BLC229182H, BLC229183H, BLC229185H, BLC229190H, BLC229215H, BLC228339H, BLC228857H, BLC228681H, BLC228692H, BLC228783H, BLC228849H, BLC228878H, BLC228924H, BLC228998H, BLC229127H, BLC229128H, BLC228543H, BLC228404H, BLC228412H, BLC228439H, BLC228797H, BLC228397H, BLC228629H, BLC228372H, BLC228773H, BLC228804H, BLC228844H, BLC229040H, BLC229186H, BLC229209H, BLC228243H, BLC229005H, BLC228303H, BLC229198H, BLC228340H, BLC228859H, BLC228767H, BLC228771H, BLC228263H, BLC228315H, BLC228780H, BLC228920H, BLC229057H, BLC228601H, BLC228666H, BLC229025H, BLC229208H, BLC228754H, BLC228764H, BLC228775H, BLC228363H, BLC228520H, BLC228549H, BLC228254H, BLC228331H, BLC228361H, BLC228381H, BLC228385H, BLC228392H, BLC228431H, BLC228442H, BLC228447H, BLC228473H, BLC228518H, BLC228831H, BLC228837H, BLC228936H, BLC228953H, BLC228978H, BLC229024H, BLC229026H, BLC229029H, BLC229073H, BLC229104H, BLC229105H, BLC229126H, BLC228529H, BLC229020H, BLC228974H, BLC228270H, BLC228225H, BLC228285H, BLC228539H, BLC228684H, BLC229058H, BLC228326H, BLC228294H, BLC228366H, BLC228766H, BLC229037H, BLC228264H, BLC229067H, BLC229164H, BLC229165H, BLC228414H, BLC228494H, BLC228735H, BLC228752H, BLC228698H, BLC228332H, BLC228633H, BLC228472H, BLC229012H, BLC228455H, BLC229015H, BLC228384H, BLC228423H, BLC228219H, BLC228306H, BLC228560H, BLC228803H, BLC228881H, BLC229060H, BLC229078H, BLC229148H, BLC228677H, BLC229115H, BLC228335H, BLC228346H, BLC228362H, BLC229202H, BLC228253H, BLC228327H, BLC228336H, BLC228380H, BLC228535H, BLC228807H, BLC228565H, BLC228602H, BLC228534H, BLC228605H, BLC228620H, BLC228913H, BLC228310H, BLC228675H, BLC229081H, BLC228323H, BLC228563H, BLC228572H, BLC228624H, BLC228682H, BLC228867H, BLC229066H, BLC228856H, BLC228661H, BLC228556H, BLC228226H, BLC228238H, BLC228259H, BLC228318H, BLC228659H, BLC228922H, BLC228343H, BLC228513H, BLC228360H, BLC228820H, BLC228957H, BLC228320H, BLC228341H, BLC228358H, BLC228370H, BLC228443H, BLC228808H, BLC228817H, BLC228847H, BLC228888H, BLC228891H, BLC228894H, BLC229091H, BLC229092H, BLC229096H, BLC228389H, BLC228373H, BLC228376H, BLC228388H, BLC228391H, BLC228489H, BLC228521H, BLC228704H, BLC229193H, BLC228989H, BLC228979H, BLC229022H, BLC229179H, BLC228234H, BLC228383H, BLC228558H, BLC228613H, BLC228945H, BLC228770H, BLC228785H, BLC228877H, BLC229135H, BLC229159H, BLC229160H, BLC229097H, BLC228255H, BLC228371H, BLC228422H, BLC228430H, BLC228433H, BLC228437H, BLC228441H, BLC228465H, BLC228474H, BLC228484H, BLC228530H, BLC228557H, BLC228588H, BLC228595H, BLC228616H, BLC228632H, BLC228645H, BLC228649H, BLC228651H, BLC228660H, BLC228689H, BLC228691H, BLC228696H, BLC228740H, BLC228762H, BLC228802H, BLC228846H, BLC228908H, BLC228949H, BLC228956H, BLC228961H, BLC228962H, BLC229035H, BLC229051H, BLC229054H, BLC229069H, BLC229076H, BLC229077H, BLC229117H, BLC228353H, BLC228777H, BLC228951H, BLC228665H, BLC228865H, BLC228892H, BLC229122H, BLC228352H, BLC228544H, BLC228407H, BLC228490H, BLC228519H, BLC228791H, BLC228806H, BLC228838H, BLC228875H, BLC229031H, BLC229074H, BLC229080H, BLC229095H, BLC229151H, BLC229153H, BLC229155H, BLC229162H, BLC228638H, BLC228886H, BLC228907H, BLC229082H, BLC229206H, BLC228481H, BLC228553H, BLC228516H, BLC228959H, BLC228410H; GTIN 00763000059651, Lot Serial Numbers: BLC600191S, BLC600409S, BLC600416S, BLC600443S, BLC600449S, BLC600318S, BLC600054S, BLC600157S, BLC600175S, BLC600354S, BLC600482S, BLC600383S, BLC600533S, BLC600129S, BLC600062S, BLC600357S, BLC600433S, BLC600083S, BLC600505S, BLC600205S, BLC600479S, BLC600499S, BLC600060S, BLC600323S, BLC600372S, BLC600489S, BLC600085S, BLC600506S, BLC600081S, BLC600349S, BLC600199S, BLC600200S, BLC600437S, BLC600300S, BLC600182S, BLC600186S, BLC600311S, BLC600188S, BLC600467S, BLC600026S, BLC600185S, BLC600494S, BLC600140S, BLC600336S, BLC600469S, BLC600075S, BLC600355S, BLC600388S, BLC600305S, BLC600287S, BLC600405S, BLC600406S, BLC600037S, BLC600120S, BLC600353S, BLC600414S, BLC600448S, BLC600462S, BLC600445S, BLC600363S, BLC600162S, BLC600358S, BLC600099S, BLC600012S, BLC600013S, BLC600014S, BLC600015S, BLC600016S, BLC600018S, BLC600019S, BLC600234S, BLC600235S, BLC600236S, BLC600237S, BLC600238S, BLC600239S, BLC600240S, BLC600244S, BLC600246S, BLC600247S, BLC600248S, BLC600249S, BLC600251S, BLC600252S, BLC600407S, BLC600190S, BLC600153S, BLC600288S, BLC600206S, BLC600321S, BLC600420S, BLC600106S, BLC600315S, BLC600473S, BLC600478S, BLC600010S, BLC600097S, BLC600112S, BLC600150S, BLC600203S, BLC600293S, BLC600301S, BLC600463S, BLC600511S, BLC600306S, BLC600327S, BLC600328S, BLC600073S, BLC600281S, BLC600282S, BLC600285S, BLC600286S, BLC600394S, BLC600396S, BLC600404S, BLC600501S, BLC600513S, BLC600517S, BLC600283S, BLC600500S, BLC600028S, BLC600386S, BLC600453S, BLC600115S, BLC600295S, BLC600076S, BLC600397S, BLC600124S, BLC600077S, BLC600187S, BLC600024S, BLC600302S, BLC600457S, BLC600103S, BLC600068S, BLC600272S, BLC600411S, BLC600461S, BLC600029S, BLC600275S, BLC600046S, BLC600134S, BLC600034S, BLC600459S, BLC600346S, BLC600021S, BLC600419S, BLC600532S, BLC600148S, BLC600173S, BLC600470S, BLC600125S, BLC600198S, BLC600002S, BLC600089S, BLC600100S, BLC600166S, BLC600260S, BLC600360S, BLC600362S, BLC600384S, BLC600410S, BLC600418S, BLC600521S, BLC600522S, BLC600531S, BLC600233S, BLC600280S, BLC600389S, BLC600497S, BLC600387S, BLC600126S, BLC600197S, BLC600369S, BLC600474S, BLC600137S, BLC600436S, BLC600067S, BLC600277S, BLC600373S, BLC600033S, BLC600043S, BLC600165S, BLC600524S, BLC600483S, BLC600065S, BLC600507S, BLC600003S, BLC600004S, BLC600007S, BLC600008S, BLC600009S, BLC600109S, BLC600044S, BLC600087S, BLC600181S, BLC600289S, BLC600450S, BLC600534S, BLC600111S, BLC600154S, BLC600045S, BLC600110S, BLC600171S, BLC600465S, BLC600061S, BLC600366S, BLC600359S, BLC600456S, BLC600147S, BLC600343S, BLC600370S, BLC600485S, BLC600486S, BLC600487S, BLC600488S, BLC600138S, BLC600274S, BLC600298S, BLC600071S, BLC600128S, BLC600380S, BLC600415S, BLC600119S, BLC600139S, BLC600174S, BLC600212S, BLC600431S, BLC600095S, BLC600368S, BLC600036S, BLC600382S, BLC600096S, BLC600291S, BLC600267S, BLC600268S, BLC600269S, BLC600270S, BLC600515S, BLC600266S, BLC600452S, BLC600042S, BLC600155S, BLC600178S, BLC600341S, BLC600422S, BLC600518S, BLC600335S, BLC600365S, BLC600214S, BLC600468S, BLC600064S, BLC600184S, BLC600379S, BLC600093S, BLC600491S, BLC600527S, BLC600347S, BLC600529S, BLC600528S, BLC600439S, BLC600345S, BLC600116S, BLC600142S, BLC600271S, BLC600427S, BLC600292S, BLC600057S, BLC600385S, BLC600259S, BLC600451S, BLC600160S, BLC600164S, BLC600204S, BLC600421S, BLC600444S, BLC600454S, BLC600480S, BLC600504S, BLC600066S, BLC600464S, BLC600052S, BLC600101S, BLC600350S, BLC600378S, BLC600179S, BLC600352S, BLC600466S, BLC600192S, BLC600208S, BLC600209S, BLC600210S, BLC600211S, BLC600215S, BLC600216S, BLC600217S, BLC600218S, BLC600219S, BLC600221S, BLC600222S, BLC600223S, BLC600224S, BLC600225S, BLC600227S, BLC600228S, BLC600230S, BLC600231S, BLC600080S, BLC600207S, BLC600426S, BLC600455S, BLC600519S, BLC600058S, BLC600348S, BLC600022S, BLC600297S, BLC600316S, BLC600371S, BLC600121S, BLC600130S, BLC600131S, BLC600132S, BLC600159S, BLC600403S, BLC600508S, BLC600047S, BLC600342S, BLC600317S, BLC600525S, BLC600429S, BLC600145S, BLC600038S, BLC600039S, BLC600040S, BLC600256S, BLC600257S, BLC600258S, BLC600183S, BLC600296S, BLC600331S, BLC600381S, BLC600477S. 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-1733-2023&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-1733-2023&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-1733-2023/fda-classification", "@type": "schema:Claim", "name": "FDA classified recall Z-1733-2023 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-1733-2023&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-1733-2023&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-1733-2023/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-1733-2023", "numberOfItems": 9, "itemListElement": [ { "@type": "schema:ListItem", "position": 1, "item": { "Field": "Recall number", "Value": "Z-1733-2023", "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 00643169720138, Lot Serial Numbers: BLC228471H, BLC228476H, BLC228533H, BLC228541H, BLC228635H, BLC228702H, BLC228745H, BLC228827H, BLC228830H, BLC228840H, BLC228872H, BLC227820H, BLC228658H, BLC228889H, BLC228890H, BLC228895H, BLC228896H, BLC228900H, BLC228350H, BLC228567H, BLC228738H, BLC229053H, BLC229197H, BLC229064H, BLC228295H, BLC228587H, BLC228382H, BLC228585H, 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BLC228865H, BLC228892H, BLC229122H, BLC228352H, BLC228544H, BLC228407H, BLC228490H, BLC228519H, BLC228791H, BLC228806H, BLC228838H, BLC228875H, BLC229031H, BLC229074H, BLC229080H, BLC229095H, BLC229151H, BLC229153H, BLC229155H, BLC229162H, BLC228638H, BLC228886H, BLC228907H, BLC229082H, BLC229206H, BLC228481H, BLC228553H, BLC228516H, BLC228959H, BLC228410H; GTIN 00763000059651, Lot Serial Numbers: BLC600191S, BLC600409S, BLC600416S, BLC600443S, BLC600449S, BLC600318S, BLC600054S, BLC600157S, BLC600175S, BLC600354S, BLC600482S, BLC600383S, BLC600533S, BLC600129S, BLC600062S, BLC600357S, BLC600433S, BLC600083S, BLC600505S, BLC600205S, BLC600479S, BLC600499S, BLC600060S, BLC600323S, BLC600372S, BLC600489S, BLC600085S, BLC600506S, BLC600081S, BLC600349S, BLC600199S, BLC600200S, BLC600437S, BLC600300S, BLC600182S, BLC600186S, BLC600311S, BLC600188S, BLC600467S, BLC600026S, BLC600185S, BLC600494S, BLC600140S, BLC600336S, BLC600469S, BLC600075S, BLC600355S, BLC600388S, BLC600305S, BLC600287S, BLC600405S, BLC600406S, BLC600037S, BLC600120S, BLC600353S, BLC600414S, BLC600448S, BLC600462S, BLC600445S, BLC600363S, BLC600162S, BLC600358S, BLC600099S, BLC600012S, BLC600013S, BLC600014S, BLC600015S, BLC600016S, BLC600018S, BLC600019S, BLC600234S, BLC600235S, BLC600236S, BLC600237S, BLC600238S, BLC600239S, BLC600240S, BLC600244S, BLC600246S, BLC600247S, BLC600248S, BLC600249S, BLC600251S, BLC600252S, BLC600407S, BLC600190S, BLC600153S, BLC600288S, BLC600206S, BLC600321S, BLC600420S, BLC600106S, BLC600315S, BLC600473S, BLC600478S, BLC600010S, BLC600097S, BLC600112S, BLC600150S, BLC600203S, BLC600293S, BLC600301S, BLC600463S, BLC600511S, BLC600306S, BLC600327S, BLC600328S, BLC600073S, BLC600281S, BLC600282S, BLC600285S, BLC600286S, BLC600394S, BLC600396S, BLC600404S, BLC600501S, BLC600513S, BLC600517S, BLC600283S, BLC600500S, BLC600028S, BLC600386S, BLC600453S, BLC600115S, BLC600295S, BLC600076S, BLC600397S, BLC600124S, BLC600077S, BLC600187S, BLC600024S, BLC600302S, BLC600457S, 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BLC600138S, BLC600274S, BLC600298S, BLC600071S, BLC600128S, BLC600380S, BLC600415S, BLC600119S, BLC600139S, BLC600174S, BLC600212S, BLC600431S, BLC600095S, BLC600368S, BLC600036S, BLC600382S, BLC600096S, BLC600291S, BLC600267S, BLC600268S, BLC600269S, BLC600270S, BLC600515S, BLC600266S, BLC600452S, BLC600042S, BLC600155S, BLC600178S, BLC600341S, BLC600422S, BLC600518S, BLC600335S, BLC600365S, BLC600214S, BLC600468S, BLC600064S, BLC600184S, BLC600379S, BLC600093S, BLC600491S, BLC600527S, BLC600347S, BLC600529S, BLC600528S, BLC600439S, BLC600345S, BLC600116S, BLC600142S, BLC600271S, BLC600427S, BLC600292S, BLC600057S, BLC600385S, BLC600259S, BLC600451S, BLC600160S, BLC600164S, BLC600204S, BLC600421S, BLC600444S, BLC600454S, BLC600480S, BLC600504S, BLC600066S, BLC600464S, BLC600052S, BLC600101S, BLC600350S, BLC600378S, BLC600179S, BLC600352S, BLC600466S, BLC600192S, BLC600208S, BLC600209S, BLC600210S, BLC600211S, BLC600215S, BLC600216S, BLC600217S, BLC600218S, BLC600219S, BLC600221S, BLC600222S, BLC600223S, BLC600224S, BLC600225S, BLC600227S, BLC600228S, BLC600230S, BLC600231S, BLC600080S, BLC600207S, BLC600426S, BLC600455S, BLC600519S, BLC600058S, BLC600348S, BLC600022S, BLC600297S, BLC600316S, BLC600371S, BLC600121S, BLC600130S, BLC600131S, BLC600132S, BLC600159S, BLC600403S, BLC600508S, BLC600047S, BLC600342S, BLC600317S, BLC600525S, BLC600429S, BLC600145S, BLC600038S, BLC600039S, BLC600040S, BLC600256S, BLC600257S, BLC600258S, BLC600183S, BLC600296S, BLC600331S, BLC600381S, BLC600477S", "Status": "recorded" } }, { "@type": "schema:ListItem", "position": 9, "item": { "Field": "Distribution pattern", "Value": "US Nationwide - Worldwide Distribution", "Status": "recorded" } } ] } ] }