{
  "@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-1741-2023.jsonld",
  "@type": "schema:Dataset",
  "name": "CRT-D DTBB1D1 VIVA S IS1/DF1 US, Model Number DTBB1D1;  Implantable Cardioverter Defibrillators",
  "description": "FDA recall Z-1741-2023 — Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) is recalling CRT-D DTBB1D1 VIVA S IS1/DF1 US, Model Number DTBB1D1;  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-1741-2023&lang=eng",
  "about": {
    "@type": "schema:MedicalDevice",
    "name": "CRT-D DTBB1D1 VIVA S IS1/DF1 US, Model Number DTBB1D1;  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-1741-2023/enforcement-record",
      "@type": "schema:Claim",
      "name": "FDA recall Z-1741-2023: Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) is recalling CRT-D DTBB1D1 VIVA S IS1/DF1 US, Model Number DTBB1D1;  Implantable Cardioverter Defibrillators",
      "text": "The FDA logged enforcement record Z-1741-2023: Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) is voluntarily recalling CRT-D DTBB1D1 VIVA S IS1/DF1 US, Model Number DTBB1D1;  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 00643169720329, Lot Serial Numbers:  BLO214422H, BLO214561H, BLO214374H, BLO214534H, BLO214440H, BLO214546H, BLO214564H, BLO214574H, BLO214347H, BLO214424H, BLO214577H, BLO214311H, BLO214464H, BLO214492H, BLO214410H, BLO214276H, BLO214283H, BLO214290H, BLO214368H, BLO214376H, BLO214395H, BLO214448H, BLO214539H, BLO214405H, BLO214499H, BLO214390H, BLO214496H, BLO214548H, BLO214344H, BLO214362H, BLO214352H, BLO214253H, BLO214274H, BLO214288H, BLO214342H, BLO214444H, BLO214327H, BLO214333H, BLO214431H, BLO214473H, BLO214273H, BLO214317H, BLO214418H, BLO214445H, BLO213867H, BLO214272H, BLO214289H, BLO214316H, BLO214526H, BLO214261H, BLO214279H, BLO214287H, BLO214296H, BLO214297H, BLO214301H, BLO214302H, BLO214303H, BLO214436H, BLO214535H, BLO214536H, BLO214543H, BLO214549H, BLO214550H, BLO214551H, BLO214552H, BLO214553H, BLO214571H, BLO214579H, BLO214581H, BLO214582H, BLO214584H, BLO214585H, BLO214586H, BLO214335H, BLO214308H, BLO214379H, BLO214348H, BLO214366H, BLO214312H, BLO214353H, BLO214530H, BLO214568H, BLO214260H, BLO214334H, BLO214413H, BLO214430H, BLO214437H, BLO214441H, BLO214475H, BLO214570H, BLO214397H, BLO214321H, BLO214394H, BLO214538H, BLO214269H, BLO214271H, BLO214282H, BLO214315H, BLO214343H, BLO214365H, BLO214383H, BLO214391H, BLO214417H, BLO214423H, BLO214446H, BLO214463H, BLO214501H, BLO214513H, BLO214532H, BLO214547H, BLO214559H, BLO214563H, BLO214565H, BLO213863H, BLO214567H, BLO214291H, BLO214295H, BLO214322H, BLO214351H, BLO214358H, BLO214369H, BLO214404H, BLO214407H, BLO214280H, BLO214416H, BLO214517H, BLO214533H, BLO214558H, BLO214452H, BLO214527H, BLO214377H, BLO214491H, BLO214460H, BLO214502H, BLO214469H, BLO214471H, BLO214506H, BLO214427H, BLO214320H, BLO214434H, BLO214453H, BLO214467H, BLO214512H, BLO214313H, BLO214447H, BLO214449H, BLO214485H, BLO214318H, BLO214415H, BLO214324H, BLO214477H, BLO214454H, BLO214281H, BLO214569H, BLO214385H, BLO214509H, BLO214419H, BLO214420H, BLO214443H, BLO214363H, BLO214520H, BLO214306H, BLO214298H, BLO214340H, BLO214503H, BLO214504H, BLO214505H, BLO214378H, BLO214451H, BLO214332H, BLO214486H, BLO214382H, BLO214286H, BLO214364H, BLO214381H, BLO214386H, BLO214406H, BLO214459H, BLO214326H, BLO213864H, BLO214408H, BLO214426H, BLO214488H, BLO214293H, BLO214264H, BLO214305H, BLO214337H, BLO214388H, BLO214432H, BLO214489H, BLO214357H, BLO214389H, BLO214392H, BLO214411H, BLO214455H, BLO214461H, BLO214494H, BLO214284H, BLO214474H, BLO214507H, BLO214555H, BLO214560H, BLO214572H, BLO214573H, BLO214576H, BLO214373H, BLO214508H. 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-1741-2023&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-1741-2023&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-1741-2023/fda-classification",
      "@type": "schema:Claim",
      "name": "FDA classified recall Z-1741-2023 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-1741-2023&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-1741-2023&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-1741-2023/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-1741-2023",
      "numberOfItems": 9,
      "itemListElement": [
        {
          "@type": "schema:ListItem",
          "position": 1,
          "item": {
            "Field": "Recall number",
            "Value": "Z-1741-2023",
            "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 00643169720329, Lot Serial Numbers:  BLO214422H, BLO214561H, BLO214374H, BLO214534H, BLO214440H, BLO214546H, BLO214564H, BLO214574H, BLO214347H, BLO214424H, BLO214577H, BLO214311H, BLO214464H, BLO214492H, BLO214410H, BLO214276H, BLO214283H, BLO214290H, BLO214368H, BLO214376H, BLO214395H, BLO214448H, BLO214539H, BLO214405H, BLO214499H, BLO214390H, BLO214496H, BLO214548H, BLO214344H, BLO214362H, BLO214352H, BLO214253H, BLO214274H, BLO214288H, BLO214342H, BLO214444H, BLO214327H, BLO214333H, BLO214431H, BLO214473H, BLO214273H, BLO214317H, BLO214418H, BLO214445H, BLO213867H, BLO214272H, BLO214289H, BLO214316H, BLO214526H, BLO214261H, BLO214279H, BLO214287H, BLO214296H, BLO214297H, BLO214301H, BLO214302H, BLO214303H, BLO214436H, BLO214535H, BLO214536H, BLO214543H, BLO214549H, BLO214550H, BLO214551H, BLO214552H, BLO214553H, BLO214571H, BLO214579H, BLO214581H, BLO214582H, BLO214584H, BLO214585H, BLO214586H, BLO214335H, BLO214308H, BLO214379H, BLO214348H, BLO214366H, BLO214312H, BLO214353H, BLO214530H, BLO214568H, BLO214260H, BLO214334H, BLO214413H, BLO214430H, BLO214437H, BLO214441H, BLO214475H, BLO214570H, BLO214397H, BLO214321H, BLO214394H, BLO214538H, BLO214269H, BLO214271H, BLO214282H, BLO214315H, BLO214343H, BLO214365H, BLO214383H, BLO214391H, BLO214417H, BLO214423H, BLO214446H, BLO214463H, BLO214501H, BLO214513H, BLO214532H, BLO214547H, BLO214559H, BLO214563H, BLO214565H, BLO213863H, BLO214567H, BLO214291H, BLO214295H, BLO214322H, BLO214351H, BLO214358H, BLO214369H, BLO214404H, BLO214407H, BLO214280H, BLO214416H, BLO214517H, BLO214533H, BLO214558H, BLO214452H, BLO214527H, BLO214377H, BLO214491H, BLO214460H, BLO214502H, BLO214469H, BLO214471H, BLO214506H, BLO214427H, BLO214320H, BLO214434H, BLO214453H, BLO214467H, BLO214512H, BLO214313H, BLO214447H, BLO214449H, BLO214485H, BLO214318H, BLO214415H, BLO214324H, BLO214477H, BLO214454H, BLO214281H, BLO214569H, BLO214385H, BLO214509H, BLO214419H, BLO214420H, BLO214443H, BLO214363H, BLO214520H, BLO214306H, BLO214298H, BLO214340H, BLO214503H, BLO214504H, BLO214505H, BLO214378H, BLO214451H, BLO214332H, BLO214486H, BLO214382H, BLO214286H, BLO214364H, BLO214381H, BLO214386H, BLO214406H, BLO214459H, BLO214326H, BLO213864H, BLO214408H, BLO214426H, BLO214488H, BLO214293H, BLO214264H, BLO214305H, BLO214337H, BLO214388H, BLO214432H, BLO214489H, BLO214357H, BLO214389H, BLO214392H, BLO214411H, BLO214455H, BLO214461H, BLO214494H, BLO214284H, BLO214474H, BLO214507H, BLO214555H, BLO214560H, BLO214572H, BLO214573H, BLO214576H, BLO214373H, BLO214508H",
            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 9,
          "item": {
            "Field": "Distribution pattern",
            "Value": "US Nationwide - Worldwide Distribution",
            "Status": "recorded"
          }
        }
      ]
    }
  ]
}