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  "name": "CRT-D DTBB1D4 VIVA S IS1/DF4 US, Model Number DTBB1D4;  Implantable Cardioverter Defibrillators",
  "description": "FDA recall Z-1742-2023 — Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) is recalling CRT-D DTBB1D4 VIVA S IS1/DF4 US, Model Number DTBB1D4;  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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      "name": "U.S. Food & Drug Administration"
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  "sameAs": "https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?action=select&recall_number=Z-1742-2023&lang=eng",
  "about": {
    "@type": "schema:MedicalDevice",
    "name": "CRT-D DTBB1D4 VIVA S IS1/DF4 US, Model Number DTBB1D4;  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-1742-2023/enforcement-record",
      "@type": "schema:Claim",
      "name": "FDA recall Z-1742-2023: Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) is recalling CRT-D DTBB1D4 VIVA S IS1/DF4 US, Model Number DTBB1D4;  Implantable Cardioverter Defibrillators",
      "text": "The FDA logged enforcement record Z-1742-2023: Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) is voluntarily recalling CRT-D DTBB1D4 VIVA S IS1/DF4 US, Model Number DTBB1D4;  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 00643169720268, Lot Serial Numbers:  BLN205385H, BLN205423H, BLN205617H, BLN205500H, BLN205517H, BLN205644H, BLN205573H, BLN205101H, BLN205395H, BLN205424H, BLN205448H, BLN205505H, BLN205574H, BLN205579H, BLN205432H, BLN205460H, BLN205545H, BLN205566H, BLN205554H, BLN205583H, BLN205390H, BLN205669H, BLN205438H, BLN205653H, BLN205533H, BLN205387H, BLN205527H, BLN205528H, BLN205571H, BLN205591H, BLN205623H, BLN205485H, BLN205501H, BLN205594H, BLN205618H, BLN205381H, BLN205462H, BLN205684H, BLN205479H, BLN205509H, BLN205627H, BLN205663H, BLN205682H, BLN205382H, BLN205384H, BLN205549H, BLN205557H, BLN205482H, BLN205454H, BLN205548H, BLN205560H, BLN205408H, BLN205521H, BLN205529H, BLN205552H, BLN205491H, BLN205645H, BLN205586H, BLN205480H, BLN205516H, BLN205486H, BLN205520H, BLN205417H, BLN205415H, BLN205558H, BLN205630H, BLN205655H, BLN205458H, BLN205435H, BLN205428H, BLN205555H, BLN205446H, BLN205420H, BLN205481H, BLN205399H, BLN205437H, BLN205459H, BLN205463H, BLN205476H, BLN205477H, BLN205518H, BLN205565H, BLN205575H, BLN205577H, BLN205611H, BLN205624H, BLN205457H, BLN205506H, BLN205643H, BLN205648H, BLN205652H, BLN205434H, BLN205456H, BLN205441H, BLN205507H, BLN205592H, BLN205650H, BLN205596H, BLN205570H, BLN205513H, BLN205413H, BLN205508H, BLN205584H, BLN205660H, BLN205674H, BLN205677H, BLN205536H, BLN205576H, BLN205610H, BLN205659H, BLN205539H, BLN205386H, BLN205499H, BLN205393H, BLN205495H, BLN205466H, BLN205502H, BLN205542H, BLN205439H, BLN205613H, BLN205561H, BLN205418H, BLN205098H, BLN205522H, BLN205535H, BLN205556H, BLN205563H, BLN205639H, BLN205651H, BLN205567H, BLN205391H, BLN205406H, BLN205416H, BLN205649H, BLN205666H, BLN205537H, BLN205546H, BLN205564H, BLN205647H, BLN205656H, BLN205664H, BLN205673H, BLN205396H, BLN205431H, BLN205442H, BLN205562H, BLN205102H, BLN205392H, BLN205608H, BLN205568H, BLN205383H, BLN205401H, BLN205489H, BLN205492H, BLN205551H, BLN205595H, BLN205657H, BLN205478H, BLN205100H, BLN205388H, BLN205410H, BLN205493H, BLN205496H, BLN205497H, BLN205498H, BLN205530H, BLN205543H, BLN205593H, BLN205597H, BLN205614H, BLN205646H, BLN205661H, BLN205667H, BLN205678H, BLN205679H, BLN205433H, BLN205532H, BLN205544H, BLN205504H, BLN205569H, BLN205572H, BLN205599H. A RECORDED FDA enforcement action (occurred=true).",
      "claimType": "official_fact",
      "reviewStatus": "current",
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      "epistemicStatus": {
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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-1742-2023&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-1742-2023&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-1742-2023/fda-classification",
      "@type": "schema:Claim",
      "name": "FDA classified recall Z-1742-2023 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": {
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        "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-1742-2023&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-1742-2023&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-1742-2023/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-1742-2023",
      "numberOfItems": 9,
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          "position": 1,
          "item": {
            "Field": "Recall number",
            "Value": "Z-1742-2023",
            "Status": "recorded"
          }
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          "@type": "schema:ListItem",
          "position": 2,
          "item": {
            "Field": "Product type",
            "Value": "Devices",
            "Status": "recorded"
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          "item": {
            "Field": "Classification",
            "Value": "Class I",
            "Status": "determination"
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            "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 00643169720268, Lot Serial Numbers:  BLN205385H, BLN205423H, BLN205617H, BLN205500H, BLN205517H, BLN205644H, BLN205573H, BLN205101H, BLN205395H, BLN205424H, BLN205448H, BLN205505H, BLN205574H, BLN205579H, BLN205432H, BLN205460H, BLN205545H, BLN205566H, BLN205554H, BLN205583H, BLN205390H, BLN205669H, BLN205438H, BLN205653H, BLN205533H, BLN205387H, BLN205527H, BLN205528H, BLN205571H, BLN205591H, BLN205623H, BLN205485H, BLN205501H, BLN205594H, BLN205618H, BLN205381H, BLN205462H, BLN205684H, BLN205479H, BLN205509H, BLN205627H, BLN205663H, BLN205682H, BLN205382H, BLN205384H, BLN205549H, BLN205557H, BLN205482H, BLN205454H, BLN205548H, BLN205560H, BLN205408H, BLN205521H, BLN205529H, BLN205552H, BLN205491H, BLN205645H, BLN205586H, BLN205480H, BLN205516H, BLN205486H, BLN205520H, BLN205417H, BLN205415H, BLN205558H, BLN205630H, BLN205655H, BLN205458H, BLN205435H, BLN205428H, BLN205555H, BLN205446H, BLN205420H, BLN205481H, BLN205399H, BLN205437H, BLN205459H, BLN205463H, BLN205476H, BLN205477H, BLN205518H, BLN205565H, BLN205575H, BLN205577H, BLN205611H, BLN205624H, BLN205457H, BLN205506H, BLN205643H, BLN205648H, BLN205652H, BLN205434H, BLN205456H, BLN205441H, BLN205507H, BLN205592H, BLN205650H, BLN205596H, BLN205570H, BLN205513H, BLN205413H, BLN205508H, BLN205584H, BLN205660H, BLN205674H, BLN205677H, BLN205536H, BLN205576H, BLN205610H, BLN205659H, BLN205539H, BLN205386H, BLN205499H, BLN205393H, BLN205495H, BLN205466H, BLN205502H, BLN205542H, BLN205439H, BLN205613H, BLN205561H, BLN205418H, BLN205098H, BLN205522H, BLN205535H, BLN205556H, BLN205563H, BLN205639H, BLN205651H, BLN205567H, BLN205391H, BLN205406H, BLN205416H, BLN205649H, BLN205666H, BLN205537H, BLN205546H, BLN205564H, BLN205647H, BLN205656H, BLN205664H, BLN205673H, BLN205396H, BLN205431H, BLN205442H, BLN205562H, BLN205102H, BLN205392H, BLN205608H, BLN205568H, BLN205383H, BLN205401H, BLN205489H, BLN205492H, BLN205551H, BLN205595H, BLN205657H, BLN205478H, BLN205100H, BLN205388H, BLN205410H, BLN205493H, BLN205496H, BLN205497H, BLN205498H, BLN205530H, BLN205543H, BLN205593H, BLN205597H, BLN205614H, BLN205646H, BLN205661H, BLN205667H, BLN205678H, BLN205679H, BLN205433H, BLN205532H, BLN205544H, BLN205504H, BLN205569H, BLN205572H, BLN205599H",
            "Status": "recorded"
          }
        },
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          "position": 9,
          "item": {
            "Field": "Distribution pattern",
            "Value": "US Nationwide - Worldwide Distribution",
            "Status": "recorded"
          }
        }
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}