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  "name": "ICD-VR DVEX3E4 EV ICD EV4 PIVOTAL, Model Number DVEX3E4;  Implantable Cardioverter Defibrillators",
  "description": "FDA recall Z-1802-2023 — Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) is recalling ICD-VR DVEX3E4 EV ICD EV4 PIVOTAL, Model Number DVEX3E4;  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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  "dateModified": "2026-06-24T07:02:03.626072+00:00",
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    "name": "openFDA drug & device enforcement (recall) reports",
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  "sameAs": "https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?action=select&recall_number=Z-1802-2023&lang=eng",
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    "name": "ICD-VR DVEX3E4 EV ICD EV4 PIVOTAL, Model Number DVEX3E4;  Implantable Cardioverter Defibrillators",
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      "name": "Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)"
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  "claims": [
    {
      "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-1802-2023/enforcement-record",
      "@type": "schema:Claim",
      "name": "FDA recall Z-1802-2023: Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) is recalling ICD-VR DVEX3E4 EV ICD EV4 PIVOTAL, Model Number DVEX3E4;  Implantable Cardioverter Defibrillators",
      "text": "The FDA logged enforcement record Z-1802-2023: Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) is voluntarily recalling ICD-VR DVEX3E4 EV ICD EV4 PIVOTAL, Model Number DVEX3E4;  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 00763000217891, Lot Serial Numbers:  EVS600719S, EVS600271S, EVS600272S, EVS600273S, EVS600274S, EVS600322S, EVS600324S, EVS600325S, EVS600326S, EVS600366S, EVS600372S, EVS600503S, EVS600504S, EVS600529S, EVS600530S, EVS600531S, EVS600547S, EVS600548S, EVS600623S, EVS600558S, EVS600559S, EVS600560S, EVS600320S, EVS600549S, EVS600550S, EVS600551S, EVS600619S, EVS600620S, EVS600633S, EVS600635S, EVS600264S, EVS600338S, EVS600339S, EVS600546S, EVS600579S, EVS600337S, EVS600578S, EVS600580S, EVS600303S, EVS600304S, EVS600305S, EVS600306S, EVS600307S, EVS600308S, EVS600319S, EVS600332S, EVS600333S, EVS600335S, EVS600340S, EVS600373S, EVS600375S, EVS600376S, EVS600377S, EVS600378S, EVS600381S, EVS600485S, EVS600486S, EVS600496S, EVS600498S, EVS600532S, EVS600541S, EVS600542S, EVS600576S, EVS600577S, EVS600616S, EVS600617S, EVS600618S, EVS600275S, EVS600277S, EVS600279S, EVS600246S, EVS600247S, EVS600248S, EVS600251S, EVS600327S, EVS600328S, EVS600095S, EVS600096S, EVS600097S, EVS600098S, EVS600252S, EVS600255S, EVS600554S, EVS600555S, EVS600561S, EVS600566S, EVS600629S, EVS600258S, EVS600259S, EVS600260S, EVS600086S, EVS600094S, EVS600256S, EVS600263S, EVS600556S, EVS600557S, EVS600085S, EVS600262S, EVS600495S, EVS600568S, EVS600534S, EVS600285S, EVS600288S, EVS600569S, EVS600570S, EVS600638S, EVS600639S, EVS600640S, EVS600393S, EVS600418S, EVS600385S, EVS600015S, EVS600016S, EVS600027S, EVS600517S, EVS600011S, EVS600012S, EVS600013S, EVS600420S, EVS600421S, EVS600014S, EVS600028S, EVS600068S, EVS600069S, EVS600070S, EVS600071S, EVS600072S, EVS600074S, EVS600078S, EVS600505S, EVS600518S, EVS600520S, EVS600720S;  GTIN 00763000217907, Lot Serial Numbers:  EVS600396S, EVS600061S, EVS600218S, EVS600204S, EVS600407S, EVS600646S, EVS600645S, EVS600647S, EVS600648S, EVS600179S, EVS600397S, EVS600040S, EVS600044S, EVS600048S, EVS600049S, EVS600139S, EVS600140S, EVS600232S, EVS600039S, EVS600056S, EVS600150S, EVS600231S, EVS600344S, EVS600141S, EVS600165S, EVS600166S, EVS600368S, EVS600351S, EVS600353S, EVS600354S, EVS600389S, EVS600390S, EVS600032S, EVS600033S, EVS600034S, EVS600045S, EVS600076S, EVS600055S, EVS600178S, EVS600155S, EVS600134S, EVS600209S, EVS600210S, EVS600205S, EVS600357S, EVS600653S, EVS600654S, EVS600050S, EVS600149S, EVS600161S, EVS600162S, EVS600164S, EVS600212S, EVS600664S, EVS600657S, EVS600658S, EVS600051S, EVS600053S, EVS600135S, EVS600211S, EVS600234S, EVS600236S, EVS600343S, EVS600348S, EVS600349S, EVS600350S, EVS600411S, EVS600412S, EVS600659S, EVS600254S, EVS600031S, EVS600159S, EVS600415S, EVS600206S, EVS600655S, EVS600656S, EVS600035S, EVS600060S, EVS600063S, EVS600157S, EVS600180S, EVS600364S, EVS600365S, EVS600643S, EVS600671S, EVS600052S, EVS600169S, EVS600170S, EVS600177S, EVS600199S, EVS600201S, EVS600202S, EVS600203S, EVS600207S, EVS600208S, EVS600220S, EVS600221S, EVS600367S, EVS600369S, EVS600371S, EVS600374S, EVS600380S, EVS600382S, EVS600384S, EVS600399S, EVS600400S, EVS600403S, EVS600423S, EVS600642S, EVS600644S, EVS600668S, EVS600669S, EVS600670S, EVS600672S, EVS600058S, EVS600057S, EVS600167S, EVS600168S, EVS600214S, EVS600153S, EVS600154S, EVS600156S, EVS600182S, EVS600408S, EVS600370S, EVS600662S, EVS600075S, EVS600649S, EVS600650S, EVS600652S, EVS600663S, EVS600651S, EVS600064S, EVS600065S, EVS600073S, EVS600142S, EVS600216S, EVS600239S, EVS600136S, EVS600137S, EVS600138S, EVS600143S, EVS600144S, EVS600145S, EVS600146S, EVS600147S, EVS600148S, EVS600158S, EVS600171S, EVS600172S, EVS600175S, EVS600036S, EVS600037S, EVS600038S, EVS600054S, EVS600641S. A RECORDED FDA enforcement action (occurred=true).",
      "claimType": "official_fact",
      "reviewStatus": "current",
      "commercialInfluence": false,
      "epistemicStatus": {
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        "adjudged": true,
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        "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-1802-2023&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-1802-2023&lang=eng"
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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."
    },
    {
      "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-1802-2023/fda-classification",
      "@type": "schema:Claim",
      "name": "FDA classified recall Z-1802-2023 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
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      "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-1802-2023&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-1802-2023&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-1802-2023/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": {
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        "supported": true,
        "adjudged": false,
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      "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."
    }
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      "name": "FDA recall details — Z-1802-2023",
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            "Value": "Z-1802-2023",
            "Status": "recorded"
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          "item": {
            "Field": "Product type",
            "Value": "Devices",
            "Status": "recorded"
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          "position": 3,
          "item": {
            "Field": "Classification",
            "Value": "Class I",
            "Status": "determination"
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          "position": 4,
          "item": {
            "Field": "Status",
            "Value": "Ongoing — the recall is still being carried out.",
            "Status": "recorded"
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          "position": 5,
          "item": {
            "Field": "Recalling firm",
            "Value": "Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)",
            "Status": "recorded"
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          "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"
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        {
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          "item": {
            "Field": "Initiated",
            "Value": "2023-05-10",
            "Status": "recorded"
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          "item": {
            "Field": "Lot/code info",
            "Value": "GTIN 00763000217891, Lot Serial Numbers:  EVS600719S, EVS600271S, EVS600272S, EVS600273S, EVS600274S, EVS600322S, EVS600324S, EVS600325S, EVS600326S, EVS600366S, EVS600372S, EVS600503S, EVS600504S, EVS600529S, EVS600530S, EVS600531S, EVS600547S, EVS600548S, EVS600623S, EVS600558S, EVS600559S, EVS600560S, EVS600320S, EVS600549S, EVS600550S, EVS600551S, EVS600619S, EVS600620S, EVS600633S, EVS600635S, EVS600264S, EVS600338S, EVS600339S, EVS600546S, EVS600579S, EVS600337S, EVS600578S, EVS600580S, EVS600303S, EVS600304S, EVS600305S, EVS600306S, EVS600307S, EVS600308S, EVS600319S, EVS600332S, EVS600333S, EVS600335S, EVS600340S, EVS600373S, EVS600375S, EVS600376S, EVS600377S, EVS600378S, EVS600381S, EVS600485S, EVS600486S, EVS600496S, EVS600498S, EVS600532S, EVS600541S, EVS600542S, EVS600576S, EVS600577S, EVS600616S, EVS600617S, EVS600618S, EVS600275S, EVS600277S, EVS600279S, EVS600246S, EVS600247S, EVS600248S, EVS600251S, EVS600327S, EVS600328S, EVS600095S, EVS600096S, EVS600097S, EVS600098S, EVS600252S, EVS600255S, EVS600554S, EVS600555S, EVS600561S, EVS600566S, EVS600629S, EVS600258S, EVS600259S, EVS600260S, EVS600086S, EVS600094S, EVS600256S, EVS600263S, EVS600556S, EVS600557S, EVS600085S, EVS600262S, EVS600495S, EVS600568S, EVS600534S, EVS600285S, EVS600288S, EVS600569S, EVS600570S, EVS600638S, EVS600639S, EVS600640S, EVS600393S, EVS600418S, EVS600385S, EVS600015S, EVS600016S, EVS600027S, EVS600517S, EVS600011S, EVS600012S, EVS600013S, EVS600420S, EVS600421S, EVS600014S, EVS600028S, EVS600068S, EVS600069S, EVS600070S, EVS600071S, EVS600072S, EVS600074S, EVS600078S, EVS600505S, EVS600518S, EVS600520S, EVS600720S;  GTIN 00763000217907, Lot Serial Numbers:  EVS600396S, EVS600061S, EVS600218S, EVS600204S, EVS600407S, EVS600646S, EVS600645S, EVS600647S, EVS600648S, EVS600179S, EVS600397S, EVS600040S, EVS600044S, EVS600048S, EVS600049S, EVS600139S, EVS600140S, EVS600232S, EVS600039S, EVS600056S, EVS600150S, EVS600231S, EVS600344S, EVS600141S, EVS600165S, EVS600166S, EVS600368S, EVS600351S, EVS600353S, EVS600354S, EVS600389S, EVS600390S, EVS600032S, EVS600033S, EVS600034S, EVS600045S, EVS600076S, EVS600055S, EVS600178S, EVS600155S, EVS600134S, EVS600209S, EVS600210S, EVS600205S, EVS600357S, EVS600653S, EVS600654S, EVS600050S, EVS600149S, EVS600161S, EVS600162S, EVS600164S, EVS600212S, EVS600664S, EVS600657S, EVS600658S, EVS600051S, EVS600053S, EVS600135S, EVS600211S, EVS600234S, EVS600236S, EVS600343S, EVS600348S, EVS600349S, EVS600350S, EVS600411S, EVS600412S, EVS600659S, EVS600254S, EVS600031S, EVS600159S, EVS600415S, EVS600206S, EVS600655S, EVS600656S, EVS600035S, EVS600060S, EVS600063S, EVS600157S, EVS600180S, EVS600364S, EVS600365S, EVS600643S, EVS600671S, EVS600052S, EVS600169S, EVS600170S, EVS600177S, EVS600199S, EVS600201S, EVS600202S, EVS600203S, EVS600207S, EVS600208S, EVS600220S, EVS600221S, EVS600367S, EVS600369S, EVS600371S, EVS600374S, EVS600380S, EVS600382S, EVS600384S, EVS600399S, EVS600400S, EVS600403S, EVS600423S, EVS600642S, EVS600644S, EVS600668S, EVS600669S, EVS600670S, EVS600672S, EVS600058S, EVS600057S, EVS600167S, EVS600168S, EVS600214S, EVS600153S, EVS600154S, EVS600156S, EVS600182S, EVS600408S, EVS600370S, EVS600662S, EVS600075S, EVS600649S, EVS600650S, EVS600652S, EVS600663S, EVS600651S, EVS600064S, EVS600065S, EVS600073S, EVS600142S, EVS600216S, EVS600239S, EVS600136S, EVS600137S, EVS600138S, EVS600143S, EVS600144S, EVS600145S, EVS600146S, EVS600147S, EVS600148S, EVS600158S, EVS600171S, EVS600172S, EVS600175S, EVS600036S, EVS600037S, EVS600038S, EVS600054S, EVS600641S",
            "Status": "recorded"
          }
        },
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          "position": 9,
          "item": {
            "Field": "Distribution pattern",
            "Value": "US Nationwide - Worldwide Distribution",
            "Status": "recorded"
          }
        }
      ]
    }
  ]
}