{ "@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-1789-2023.jsonld", "@type": "schema:Dataset", "name": "ICD-VR DVAB1D1 VISIA AF US IS1/DF1, Model Number DVAB1D1; Implantable Cardioverter Defibrillators", "description": "FDA recall Z-1789-2023 — Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) is recalling ICD-VR DVAB1D1 VISIA AF US IS1/DF1, Model Number DVAB1D1; 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-1789-2023&lang=eng", "about": { "@type": "schema:MedicalDevice", "name": "ICD-VR DVAB1D1 VISIA AF US IS1/DF1, Model Number DVAB1D1; 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-1789-2023/enforcement-record", "@type": "schema:Claim", "name": "FDA recall Z-1789-2023: Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) is recalling ICD-VR DVAB1D1 VISIA AF US IS1/DF1, Model Number DVAB1D1; Implantable Cardioverter Defibrillators", "text": "The FDA logged enforcement record Z-1789-2023: Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) is voluntarily recalling ICD-VR DVAB1D1 VISIA AF US IS1/DF1, Model Number DVAB1D1; 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 00643169720619, Lot Serial Numbers: BWN203363H, BWN203588H, BWN203428H, BWN203504H, BWN203530H, BWN203214H, BWN203258H, BWN203259H, BWN203304H, BWN203477H, BWN203665H, BWN203423H, BWN203403H, BWN203327H, BWN203518H, BWN203790H, BWN203174H, BWN203624H, BWN203750H, BWN203763H, BWN203786H, BWN203745H, BWN203526H, BWN203813H, BWN203168H, BWN203236H, BWN203374H, BWN203463H, BWN203640H, BWN203213H, BWN203431H, BWN203492H, BWN203585H, BWN203436H, BWN203524H, BWN203528H, BWN203809H, BWN203432H, BWN203231H, BWN203199H, BWN203163H, BWN203193H, BWN203306H, BWN203310H, BWN203352H, BWN203373H, BWN203433H, BWN203575H, BWN203611H, BWN203616H, BWN203689H, BWN203732H, BWN203739H, BWN203749H, BWN203796H, BWN203799H, BWN203803H, BWN203181H, BWN203642H, BWN203202H, BWN203758H, BWN203671H, BWN203769H, BWN203357H, BWN203248H, BWN203253H, BWN203448H, BWN203664H, BWN203733H, BWN203260H, BWN203347H, BWN203408H, BWN203422H, BWN203535H, BWN203582H, BWN203712H, BWN203770H, BWN203697H, BWN203205H, BWN203410H, BWN203590H, BWN203332H, BWN203381H, BWN203430H, BWN203511H, BWN203737H, BWN203355H, BWN203703H, BWN203625H, BWN203380H, BWN203498H, BWN203620H, BWN203622H, BWN203810H, BWN203681H, BWN203685H, BWN203434H, BWN203653H, BWN203564H, BWN203169H, BWN203188H, BWN203186H, BWN203318H, BWN203325H, BWN203544H, BWN203468H, BWN203727H, BWN203283H, BWN203693H, BWN203667H, BWN203180H, BWN203660H, BWN203584H, BWN203386H, BWN203806H, BWN203543H, BWN203417H, BWN203395H, BWN203549H, BWN203279H, BWN203326H, BWN203706H, BWN203726H, BWN203744H, BWN203583H, BWN203365H, BWN203556H, BWN203709H, BWN203730H, BWN203203H, BWN203443H, BWN203243H, BWN203331H, BWN203315H, BWN203419H, BWN203643H, BWN203760H, BWN203520H, BWN203607H, BWN203710H, BWN203540H, BWN203265H, BWN203293H, BWN203299H, BWN203517H, BWN203354H, BWN203371H, BWN203398H, BWN203273H, BWN203369H, BWN203450H, BWN203474H, BWN203694H, BWN203774H, BWN203288H, BWN203316H, BWN203487H, BWN203538H, BWN203553H, BWN203555H, BWN203618H, BWN203294H, BWN203690H, BWN203531H, BWN203159H, BWN203731H, BWN203787H, BWN203254H, BWN203480H, BWN203599H, BWN203157H, BWN203246H, BWN203581H, BWN203776H, BWN203211H, BWN203451H, BWN203789H, BWN203233H, BWN203356H, BWN203808H, BWN203212H, BWN203191H, BWN203447H, BWN203473H, BWN203413H, BWN203414H, BWN203415H, BWN203416H, BWN203486H, BWN203489H, BWN203516H, BWN203688H, BWN203815H, BWN203235H, BWN203648H, BWN203167H, BWN203702H, BWN203290H, BWN203296H, BWN203183H, BWN203781H, BWN203284H, BWN203635H, BWN203456H, BWN203472H, BWN203580H, BWN203691H, BWN203794H, BWN203382H, BWN203229H, BWN203247H, BWN203256H, BWN203264H, BWN203274H, BWN203277H, BWN203302H, BWN203532H, BWN202561H, BWN203228H, BWN203250H, BWN203268H, BWN203269H, BWN203270H, BWN203275H, BWN203292H, BWN203420H, BWN203440H, BWN203509H, BWN203548H, BWN203615H, BWN203656H, BWN203680H, BWN203716H, BWN203722H, BWN203771H, BWN203782H, BWN203404H, BWN203657H, BWN203788H, BWN203192H, BWN203397H, BWN203461H, BWN203513H, BWN203215H, BWN203578H, BWN203720H, BWN203747H, BWN203773H, BWN203683H, BWN203409H, BWN203597H, BWN203539H, BWN203351H, BWN203334H, BWN203639H, BWN203714H, BWN203728H, BWN203654H, BWN203695H, BWN203340H, BWN203343H, BWN203601H, BWN203336H, BWN203406H, BWN203178H, BWN203196H, BWN203696H, BWN203429H, BWN203378H, BWN203185H, BWN203562H, BWN203223H, BWN203641H, BWN203718H, BWN203319H, BWN203508H, BWN203603H, BWN203692H, BWN203777H, BWN203800H, BWN203400H, BWN203627H, BWN203208H, BWN203224H, BWN203179H, BWN203482H, BWN203418H, BWN203375H, BWN203658H, BWN203367H, BWN203701H, BWN203301H, BWN203445H, BWN203234H, BWN203478H, BWN203672H, BWN203673H, BWN203725H, BWN203757H, BWN203263H, BWN203500H, BWN203298H, BWN203467H, BWN203778H, BWN203546H, BWN203795H, BWN203682H, BWN203605H, BWN203242H, BWN203335H, BWN203170H, BWN203469H, BWN203804H, BWN203190H, BWN203278H, BWN203700H, BWN203743H, BWN203748H, BWN203762H, BWN203766H, BWN203322H, BWN203437H, BWN203438H, BWN203439H, BWN203204H, BWN203172H, BWN203182H, BWN203314H, BWN203324H, BWN203402H, BWN203529H, BWN203566H, BWN203592H, BWN203594H, BWN203595H, BWN203705H, BWN203734H, BWN203441H, BWN203444H, BWN203717H, BWN203194H, BWN203483H, BWN203527H, BWN203577H, BWN203662H, BWN203499H, BWN203217H, BWN203736H, BWN203545H, BWN203266H, BWN202560H, BWN203389H, BWN203589H, BWN203659H, BWN203670H, BWN203166H, BWN203591H, BWN203779H, BWN203465H, BWN203614H, BWN203661H, BWN203198H, BWN203554H, BWN203219H, BWN203617H, BWN203551H, BWN203312H, BWN203792H, BWN203515H, BWN203390H, BWN203189H, BWN203462H, BWN203241H, BWN203704H, BWN203328H, BWN203305H, BWN203323H, BWN203568H, BWN203557H, BWN203384H, BWN203164H, BWN203333H, BWN203519H, BWN203707H, BWN203244H, BWN203307H, BWN203547H, BWN203421H, BWN203377H, BWN203501H, BWN203227H, BWN203764H, BWN203721H, BWN203220H, BWN203724H, BWN203184H, BWN203177H, BWN203245H, BWN203262H, BWN203542H, BWN203613H, BWN203649H, BWN203699H, BWN203173H, BWN203491H, BWN203295H, BWN203756H, BWN203338H, BWN203514H, BWN203161H, BWN203396H, BWN203647H, BWN203506H, BWN203507H, BWN203353H, BWN203715H, BWN203249H, BWN203723H, BWN203485H, BWN203572H, BWN203646H, BWN203678H, BWN203496H, BWN203240H, BWN203560H. 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-1789-2023&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-1789-2023&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-1789-2023/fda-classification", "@type": "schema:Claim", "name": "FDA classified recall Z-1789-2023 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-1789-2023&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-1789-2023&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-1789-2023/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-1789-2023", "numberOfItems": 9, "itemListElement": [ { "@type": "schema:ListItem", "position": 1, "item": { "Field": "Recall number", "Value": "Z-1789-2023", "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 00643169720619, Lot Serial Numbers: BWN203363H, BWN203588H, BWN203428H, BWN203504H, BWN203530H, BWN203214H, BWN203258H, BWN203259H, BWN203304H, BWN203477H, BWN203665H, BWN203423H, BWN203403H, BWN203327H, BWN203518H, BWN203790H, BWN203174H, BWN203624H, BWN203750H, BWN203763H, BWN203786H, BWN203745H, BWN203526H, BWN203813H, BWN203168H, BWN203236H, BWN203374H, BWN203463H, BWN203640H, BWN203213H, BWN203431H, BWN203492H, BWN203585H, BWN203436H, BWN203524H, BWN203528H, BWN203809H, BWN203432H, BWN203231H, BWN203199H, BWN203163H, BWN203193H, BWN203306H, BWN203310H, BWN203352H, BWN203373H, BWN203433H, BWN203575H, BWN203611H, BWN203616H, BWN203689H, BWN203732H, BWN203739H, BWN203749H, BWN203796H, BWN203799H, BWN203803H, BWN203181H, BWN203642H, BWN203202H, BWN203758H, BWN203671H, BWN203769H, BWN203357H, BWN203248H, BWN203253H, BWN203448H, BWN203664H, BWN203733H, BWN203260H, BWN203347H, BWN203408H, BWN203422H, BWN203535H, BWN203582H, BWN203712H, BWN203770H, BWN203697H, BWN203205H, BWN203410H, BWN203590H, BWN203332H, BWN203381H, BWN203430H, BWN203511H, BWN203737H, BWN203355H, BWN203703H, BWN203625H, BWN203380H, BWN203498H, BWN203620H, BWN203622H, BWN203810H, BWN203681H, BWN203685H, BWN203434H, BWN203653H, BWN203564H, BWN203169H, BWN203188H, BWN203186H, BWN203318H, BWN203325H, BWN203544H, BWN203468H, BWN203727H, BWN203283H, BWN203693H, BWN203667H, BWN203180H, BWN203660H, BWN203584H, BWN203386H, BWN203806H, BWN203543H, BWN203417H, BWN203395H, BWN203549H, BWN203279H, BWN203326H, BWN203706H, BWN203726H, BWN203744H, BWN203583H, BWN203365H, BWN203556H, BWN203709H, BWN203730H, BWN203203H, BWN203443H, BWN203243H, BWN203331H, BWN203315H, BWN203419H, BWN203643H, BWN203760H, BWN203520H, BWN203607H, BWN203710H, BWN203540H, BWN203265H, BWN203293H, BWN203299H, BWN203517H, BWN203354H, BWN203371H, BWN203398H, BWN203273H, BWN203369H, BWN203450H, BWN203474H, BWN203694H, BWN203774H, BWN203288H, BWN203316H, BWN203487H, BWN203538H, BWN203553H, BWN203555H, BWN203618H, BWN203294H, BWN203690H, BWN203531H, BWN203159H, BWN203731H, BWN203787H, BWN203254H, BWN203480H, BWN203599H, BWN203157H, BWN203246H, BWN203581H, BWN203776H, BWN203211H, BWN203451H, BWN203789H, BWN203233H, BWN203356H, BWN203808H, BWN203212H, BWN203191H, BWN203447H, BWN203473H, BWN203413H, BWN203414H, BWN203415H, BWN203416H, BWN203486H, BWN203489H, BWN203516H, BWN203688H, BWN203815H, BWN203235H, BWN203648H, BWN203167H, BWN203702H, BWN203290H, BWN203296H, BWN203183H, BWN203781H, BWN203284H, BWN203635H, BWN203456H, BWN203472H, BWN203580H, BWN203691H, BWN203794H, BWN203382H, BWN203229H, BWN203247H, BWN203256H, BWN203264H, BWN203274H, BWN203277H, BWN203302H, BWN203532H, BWN202561H, BWN203228H, BWN203250H, BWN203268H, BWN203269H, BWN203270H, BWN203275H, BWN203292H, BWN203420H, BWN203440H, BWN203509H, BWN203548H, BWN203615H, BWN203656H, BWN203680H, BWN203716H, BWN203722H, BWN203771H, BWN203782H, BWN203404H, BWN203657H, BWN203788H, BWN203192H, BWN203397H, BWN203461H, BWN203513H, BWN203215H, BWN203578H, BWN203720H, BWN203747H, BWN203773H, BWN203683H, BWN203409H, BWN203597H, BWN203539H, BWN203351H, BWN203334H, BWN203639H, BWN203714H, BWN203728H, BWN203654H, BWN203695H, BWN203340H, BWN203343H, BWN203601H, BWN203336H, BWN203406H, BWN203178H, BWN203196H, BWN203696H, BWN203429H, BWN203378H, BWN203185H, BWN203562H, BWN203223H, BWN203641H, BWN203718H, BWN203319H, BWN203508H, BWN203603H, BWN203692H, BWN203777H, BWN203800H, BWN203400H, BWN203627H, BWN203208H, BWN203224H, BWN203179H, BWN203482H, BWN203418H, BWN203375H, BWN203658H, BWN203367H, BWN203701H, BWN203301H, BWN203445H, BWN203234H, BWN203478H, BWN203672H, BWN203673H, BWN203725H, BWN203757H, BWN203263H, BWN203500H, BWN203298H, BWN203467H, BWN203778H, BWN203546H, BWN203795H, BWN203682H, BWN203605H, BWN203242H, BWN203335H, BWN203170H, BWN203469H, BWN203804H, BWN203190H, BWN203278H, BWN203700H, BWN203743H, BWN203748H, BWN203762H, BWN203766H, BWN203322H, BWN203437H, BWN203438H, BWN203439H, BWN203204H, BWN203172H, BWN203182H, BWN203314H, BWN203324H, BWN203402H, BWN203529H, BWN203566H, BWN203592H, BWN203594H, BWN203595H, BWN203705H, BWN203734H, BWN203441H, BWN203444H, BWN203717H, BWN203194H, BWN203483H, BWN203527H, BWN203577H, BWN203662H, BWN203499H, BWN203217H, BWN203736H, BWN203545H, BWN203266H, BWN202560H, BWN203389H, BWN203589H, BWN203659H, BWN203670H, BWN203166H, BWN203591H, BWN203779H, BWN203465H, BWN203614H, BWN203661H, BWN203198H, BWN203554H, BWN203219H, BWN203617H, BWN203551H, BWN203312H, BWN203792H, BWN203515H, BWN203390H, BWN203189H, BWN203462H, BWN203241H, BWN203704H, BWN203328H, BWN203305H, BWN203323H, BWN203568H, BWN203557H, BWN203384H, BWN203164H, BWN203333H, BWN203519H, BWN203707H, BWN203244H, BWN203307H, BWN203547H, BWN203421H, BWN203377H, BWN203501H, BWN203227H, BWN203764H, BWN203721H, BWN203220H, BWN203724H, BWN203184H, BWN203177H, BWN203245H, BWN203262H, BWN203542H, BWN203613H, BWN203649H, BWN203699H, BWN203173H, BWN203491H, BWN203295H, BWN203756H, BWN203338H, BWN203514H, BWN203161H, BWN203396H, BWN203647H, BWN203506H, BWN203507H, BWN203353H, BWN203715H, BWN203249H, BWN203723H, BWN203485H, BWN203572H, BWN203646H, BWN203678H, BWN203496H, BWN203240H, BWN203560H", "Status": "recorded" } }, { "@type": "schema:ListItem", "position": 9, "item": { "Field": "Distribution pattern", "Value": "US Nationwide - Worldwide Distribution", "Status": "recorded" } } ] } ] }