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  "name": "ICD-VR VISIA AF S US/OUS IS1/DF1, Model Number DVAC3D1;  Implantable Cardioverter Defibrillators",
  "description": "FDA recall Z-1793-2023 — Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) is recalling ICD-VR VISIA AF S US/OUS IS1/DF1, Model Number DVAC3D1;  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-1793-2023&lang=eng",
  "about": {
    "@type": "schema:MedicalDevice",
    "name": "ICD-VR VISIA AF S US/OUS IS1/DF1, Model Number DVAC3D1;  Implantable Cardioverter Defibrillators",
    "manufacturer": {
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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-1793-2023/enforcement-record",
      "@type": "schema:Claim",
      "name": "FDA recall Z-1793-2023: Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) is recalling ICD-VR VISIA AF S US/OUS IS1/DF1, Model Number DVAC3D1;  Implantable Cardioverter Defibrillators",
      "text": "The FDA logged enforcement record Z-1793-2023: Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) is voluntarily recalling ICD-VR VISIA AF S US/OUS IS1/DF1, Model Number DVAC3D1;  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 00643169720770, Lot Serial numbers:  BWU600672S, BWU600685S, BWU600654S, BWU600656S, BWU600555S, BWU600638S, BWU600641S, BWU600642S, BWU600647S, BWU600648S, BWU600650S, BWU600651S, BWU600664S, BWU600643S, BWU600645S, BWU600557S, BWU600556S, BWU600763S, BWU600640S, BWU600639S, BWU600649S, BWU600661S, BWU600662S, BWU600663S, BWU600665S, BWU600666S, BWU600671S, BWU600673S, BWU600676S, BWU600646S, BWU600652S, BWU600653S, BWU600655S, BWU600658S, BWU600659S, BWU600667S, BWU600668S, BWU600669S, BWU600684S, BWU600694S, BWU600695S, BWU600696S, BWU600697S, BWU600698S, BWU600699S, BWU600700S, BWU600701S, BWU600702S, BWU600703S, BWU600707S, BWU600708S, BWU600709S, BWU600710S, BWU600711S, BWU600714S, BWU600715S, BWU600716S, BWU600739S, BWU600741S, BWU600758S, BWU600760S, BWU600761S, BWU600762S, BWU600764S, BWU600765S, BWU600766S, BWU600712S, BWU600644S;  GTIN 00763000052713, Lot Numbers:  BWU600776S, BWU600721S, BWU600810S, BWU600771S, BWU600772S, BWU600774S, BWU600723S, BWU600795S, BWU600820S, BWU600720S, BWU600782S, BWU600768S, BWU600719S, BWU600793S, BWU600717S, BWU600718S, BWU600722S, BWU600726S, BWU600727S, BWU600728S, BWU600729S, BWU600730S, BWU600735S, BWU600778S, BWU600807S, BWU600808S, BWU600809S, BWU600813S, BWU600814S, BWU600815S, BWU600816S, BWU600817S, BWU600819S, BWU600821S, BWU600822S, BWU600830S, BWU600831S, BWU600833S, BWU600834S, BWU600835S, BWU600836S, BWU600704S, BWU600705S, BWU600736S, BWU600767S, BWU600806S, BWU600848S, BWU600849S, BWU600850S, BWU600870S, BWU600876S, BWU600936S, BWU600937S, BWU600939S, BWU600940S, BWU600941S, BWU600769S, BWU600770S, BWU600841S, BWU600845S, BWU600847S, BWU600852S, BWU600853S, BWU600855S, BWU600856S, BWU600860S, BWU600862S, BWU600864S, BWU600869S, BWU600872S, BWU600827S, BWU600828S, BWU600877S, BWU600880S, BWU600886S, BWU600888S, BWU600891S, BWU600893S, BWU600897S, BWU600905S, BWU600907S, BWU600909S, BWU600915S, BWU600916S, BWU600917S, BWU600918S, BWU600919S, BWU600920S, BWU600921S, BWU600775S, BWU600788S, BWU600804S, BWU600777S, BWU600779S, BWU600805S, BWU600832S, BWU600930S, BWU600931S, BWU600914S, BWU600942S, BWU600943S, BWU600944S, BWU600945S, BWU600947S, BWU600951S, BWU600953S, BWU600955S, BWU600956S. A RECORDED FDA enforcement action (occurred=true).",
      "claimType": "official_fact",
      "reviewStatus": "current",
      "commercialInfluence": false,
      "epistemicStatus": {
        "occurred": true,
        "supported": true,
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      "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-1793-2023&lang=eng",
        "value": "Devices recall, status Ongoing",
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          "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-1793-2023&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."
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    {
      "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-1793-2023/fda-classification",
      "@type": "schema:Claim",
      "name": "FDA classified recall Z-1793-2023 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-1793-2023&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-1793-2023&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-1793-2023/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
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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-1793-2023",
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          "position": 1,
          "item": {
            "Field": "Recall number",
            "Value": "Z-1793-2023",
            "Status": "recorded"
          }
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          "@type": "schema:ListItem",
          "position": 2,
          "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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          "position": 7,
          "item": {
            "Field": "Initiated",
            "Value": "2023-05-10",
            "Status": "recorded"
          }
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          "position": 8,
          "item": {
            "Field": "Lot/code info",
            "Value": "GTIN 00643169720770, Lot Serial numbers:  BWU600672S, BWU600685S, BWU600654S, BWU600656S, BWU600555S, BWU600638S, BWU600641S, BWU600642S, BWU600647S, BWU600648S, BWU600650S, BWU600651S, BWU600664S, BWU600643S, BWU600645S, BWU600557S, BWU600556S, BWU600763S, BWU600640S, BWU600639S, BWU600649S, BWU600661S, BWU600662S, BWU600663S, BWU600665S, BWU600666S, BWU600671S, BWU600673S, BWU600676S, BWU600646S, BWU600652S, BWU600653S, BWU600655S, BWU600658S, BWU600659S, BWU600667S, BWU600668S, BWU600669S, BWU600684S, BWU600694S, BWU600695S, BWU600696S, BWU600697S, BWU600698S, BWU600699S, BWU600700S, BWU600701S, BWU600702S, BWU600703S, BWU600707S, BWU600708S, BWU600709S, BWU600710S, BWU600711S, BWU600714S, BWU600715S, BWU600716S, BWU600739S, BWU600741S, BWU600758S, BWU600760S, BWU600761S, BWU600762S, BWU600764S, BWU600765S, BWU600766S, BWU600712S, BWU600644S;  GTIN 00763000052713, Lot Numbers:  BWU600776S, BWU600721S, BWU600810S, BWU600771S, BWU600772S, BWU600774S, BWU600723S, BWU600795S, BWU600820S, BWU600720S, BWU600782S, BWU600768S, BWU600719S, BWU600793S, BWU600717S, BWU600718S, BWU600722S, BWU600726S, BWU600727S, BWU600728S, BWU600729S, BWU600730S, BWU600735S, BWU600778S, BWU600807S, BWU600808S, BWU600809S, BWU600813S, BWU600814S, BWU600815S, BWU600816S, BWU600817S, BWU600819S, BWU600821S, BWU600822S, BWU600830S, BWU600831S, BWU600833S, BWU600834S, BWU600835S, BWU600836S, BWU600704S, BWU600705S, BWU600736S, BWU600767S, BWU600806S, BWU600848S, BWU600849S, BWU600850S, BWU600870S, BWU600876S, BWU600936S, BWU600937S, BWU600939S, BWU600940S, BWU600941S, BWU600769S, BWU600770S, BWU600841S, BWU600845S, BWU600847S, BWU600852S, BWU600853S, BWU600855S, BWU600856S, BWU600860S, BWU600862S, BWU600864S, BWU600869S, BWU600872S, BWU600827S, BWU600828S, BWU600877S, BWU600880S, BWU600886S, BWU600888S, BWU600891S, BWU600893S, BWU600897S, BWU600905S, BWU600907S, BWU600909S, BWU600915S, BWU600916S, BWU600917S, BWU600918S, BWU600919S, BWU600920S, BWU600921S, BWU600775S, BWU600788S, BWU600804S, BWU600777S, BWU600779S, BWU600805S, BWU600832S, BWU600930S, BWU600931S, BWU600914S, BWU600942S, BWU600943S, BWU600944S, BWU600945S, BWU600947S, BWU600951S, BWU600953S, BWU600955S, BWU600956S",
            "Status": "recorded"
          }
        },
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          "@type": "schema:ListItem",
          "position": 9,
          "item": {
            "Field": "Distribution pattern",
            "Value": "US Nationwide - Worldwide Distribution",
            "Status": "recorded"
          }
        }
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    }
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}