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  "name": "ICD-VR VISIA AF S US/OUS DF4, Model Number DVAC3D4;  Implantable Cardioverter Defibrillators",
  "description": "FDA recall Z-1794-2023 — Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) is recalling ICD-VR VISIA AF S US/OUS DF4, Model Number DVAC3D4;  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.",
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    "name": "ICD-VR VISIA AF S US/OUS DF4, Model Number DVAC3D4;  Implantable Cardioverter Defibrillators",
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      "name": "Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)"
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      "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-1794-2023/enforcement-record",
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      "name": "FDA recall Z-1794-2023: Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) is recalling ICD-VR VISIA AF S US/OUS DF4, Model Number DVAC3D4;  Implantable Cardioverter Defibrillators",
      "text": "The FDA logged enforcement record Z-1794-2023: Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) is voluntarily recalling ICD-VR VISIA AF S US/OUS DF4, Model Number DVAC3D4;  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 00643169720787, Lot Serial Numbers:  BWV600051S, BWV600052S, BWV600078S, BWV600079S, BWV600010S, BWV600094S, BWV600024S, BWV600027S, BWV600031S, BWV600032S, BWV600041S, BWV600042S, BWV600043S, BWV600044S, BWV600045S, BWV600046S, BWV600047S, BWV600068S, BWV600069S, BWV600070S, BWV600071S, BWV600072S, BWV600073S, BWV600074S, BWV600087S, BWV600088S, BWV600089S, BWV600090S, BWV600099S, BWV600101S, BWV600105S, BWV600107S, BWV600108S, BWV600109S, BWV600110S, BWV600111S, BWV600112S, BWV600113S, BWV600114S, BWV600115S, BWV600155S, BWV600157S, BWV600160S, BWV600161S, BWV600162S, BWV600163S, BWV600164S, BWV600165S, BWV600166S, BWV600167S, BWV600168S, BWV600170S, BWV600171S, BWV600172S, BWV600173S, BWV600174S, BWV600175S, BWV600176S, BWV600177S, BWV600178S, BWV600179S, BWV600180S, BWV600181S, BWV600183S, BWV600184S, BWV600185S, BWV600186S, BWV600187S, BWV600022S, BWV600025S, BWV600026S, BWV600028S, BWV600029S, BWV600030S, BWV600033S, BWV600034S, BWV600035S, BWV600036S, BWV600037S, BWV600038S, BWV600039S, BWV600040S, BWV600048S, BWV600049S, BWV600050S, BWV600055S, BWV600056S, BWV600057S, BWV600058S, BWV600059S, BWV600060S, BWV600061S, BWV600062S, BWV600063S, BWV600064S, BWV600065S, BWV600066S, BWV600067S, BWV600080S, BWV600081S, BWV600082S, BWV600083S, BWV600084S, BWV600085S, BWV600086S, BWV600091S, BWV600092S, BWV600093S, BWV600095S, BWV600096S, BWV600100S, BWV600103S, BWV600116S, BWV600117S, BWV600118S, BWV600119S, BWV600120S, BWV600121S, BWV600122S, BWV600123S, BWV600124S, BWV600125S, BWV600126S, BWV600127S, BWV600128S, BWV600129S, BWV600130S, BWV600131S, BWV600132S, BWV600133S, BWV600134S, BWV600135S, BWV600136S, BWV600137S, BWV600138S, BWV600139S, BWV600140S, BWV600141S, BWV600142S, BWV600143S, BWV600144S, BWV600145S, BWV600146S, BWV600147S, BWV600148S, BWV600149S, BWV600151S, BWV600102S, BWV600097S;  GTIN 00763000052720, Lot Serial Numbers:  BWV600261S, BWV600263S, BWV600265S, BWV600267S, BWV600258S, BWV600259S, BWV600284S, BWV600285S, BWV600286S, BWV600287S, BWV600288S, BWV600289S, BWV600290S, BWV600291S, BWV600292S, BWV600293S, BWV600294S, BWV600295S, BWV600296S, BWV600297S, BWV600298S, BWV600300S, BWV600301S, BWV600302S, BWV600303S, BWV600304S, BWV600305S, BWV600306S, BWV600307S, BWV600308S, BWV600309S, BWV600310S, BWV600311S, BWV600312S, BWV600313S, BWV600314S, BWV600315S, BWV600316S, BWV600317S, BWV600318S, BWV600320S, BWV600266S, BWV600260S, BWV600262S, BWV600264S. A RECORDED FDA enforcement action (occurred=true).",
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        "value": "Devices recall, status Ongoing",
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      "falsifier": "A RECORD of measured/reported events (occurred=true) from openFDA drug & device enforcement (recall) reports — U.S. FDA; superseded when openFDA drug & device enforcement (recall) reports — U.S. FDA publishes its next release."
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      "name": "FDA classified recall Z-1794-2023 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.",
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          "name": "U.S. FDA recall classification (openFDA enforcement)",
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      "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-1794-2023/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.",
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      "commercialInfluence": false,
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        "source": "Atlas Commons L5 boundary (enforcement-action ≠ harm causation)",
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        "value": "a recorded enforcement action, not proof of harm or causation; not medical advice",
        "adjudicator": null
      },
      "falsifier": "occurred=FALSE (a framing, not an event) and adjudged=FALSE (an in-house reading, not an authority's verdict) — the LOWEST-warrant claim here. A flat representation would render this identically to the official facts; the four-status does not."
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      "name": "FDA recall details — Z-1794-2023",
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            "Value": "Z-1794-2023",
            "Status": "recorded"
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            "Value": "Devices",
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            "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"
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          "item": {
            "Field": "Initiated",
            "Value": "2023-05-10",
            "Status": "recorded"
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            "Field": "Lot/code info",
            "Value": "GTIN 00643169720787, Lot Serial Numbers:  BWV600051S, BWV600052S, BWV600078S, BWV600079S, BWV600010S, BWV600094S, BWV600024S, BWV600027S, BWV600031S, BWV600032S, BWV600041S, BWV600042S, BWV600043S, BWV600044S, BWV600045S, BWV600046S, BWV600047S, BWV600068S, BWV600069S, BWV600070S, BWV600071S, BWV600072S, BWV600073S, BWV600074S, BWV600087S, BWV600088S, BWV600089S, BWV600090S, BWV600099S, BWV600101S, BWV600105S, BWV600107S, BWV600108S, BWV600109S, BWV600110S, BWV600111S, BWV600112S, BWV600113S, BWV600114S, BWV600115S, BWV600155S, BWV600157S, BWV600160S, BWV600161S, BWV600162S, BWV600163S, BWV600164S, BWV600165S, BWV600166S, BWV600167S, BWV600168S, BWV600170S, BWV600171S, BWV600172S, BWV600173S, BWV600174S, BWV600175S, BWV600176S, BWV600177S, BWV600178S, BWV600179S, BWV600180S, BWV600181S, BWV600183S, BWV600184S, BWV600185S, BWV600186S, BWV600187S, BWV600022S, BWV600025S, BWV600026S, BWV600028S, BWV600029S, BWV600030S, BWV600033S, BWV600034S, BWV600035S, BWV600036S, BWV600037S, BWV600038S, BWV600039S, BWV600040S, BWV600048S, BWV600049S, BWV600050S, BWV600055S, BWV600056S, BWV600057S, BWV600058S, BWV600059S, BWV600060S, BWV600061S, BWV600062S, BWV600063S, BWV600064S, BWV600065S, BWV600066S, BWV600067S, BWV600080S, BWV600081S, BWV600082S, BWV600083S, BWV600084S, BWV600085S, BWV600086S, BWV600091S, BWV600092S, BWV600093S, BWV600095S, BWV600096S, BWV600100S, BWV600103S, BWV600116S, BWV600117S, BWV600118S, BWV600119S, BWV600120S, BWV600121S, BWV600122S, BWV600123S, BWV600124S, BWV600125S, BWV600126S, BWV600127S, BWV600128S, BWV600129S, BWV600130S, BWV600131S, BWV600132S, BWV600133S, BWV600134S, BWV600135S, BWV600136S, BWV600137S, BWV600138S, BWV600139S, BWV600140S, BWV600141S, BWV600142S, BWV600143S, BWV600144S, BWV600145S, BWV600146S, BWV600147S, BWV600148S, BWV600149S, BWV600151S, BWV600102S, BWV600097S;  GTIN 00763000052720, Lot Serial Numbers:  BWV600261S, BWV600263S, BWV600265S, BWV600267S, BWV600258S, BWV600259S, BWV600284S, BWV600285S, BWV600286S, BWV600287S, BWV600288S, BWV600289S, BWV600290S, BWV600291S, BWV600292S, BWV600293S, BWV600294S, BWV600295S, BWV600296S, BWV600297S, BWV600298S, BWV600300S, BWV600301S, BWV600302S, BWV600303S, BWV600304S, BWV600305S, BWV600306S, BWV600307S, BWV600308S, BWV600309S, BWV600310S, BWV600311S, BWV600312S, BWV600313S, BWV600314S, BWV600315S, BWV600316S, BWV600317S, BWV600318S, BWV600320S, BWV600266S, BWV600260S, BWV600262S, BWV600264S",
            "Status": "recorded"
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          "item": {
            "Field": "Distribution pattern",
            "Value": "US Nationwide - Worldwide Distribution",
            "Status": "recorded"
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