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  "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-1744-2023.jsonld",
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  "name": "CRT-D DTBB1QQ VIVA QUAD S IS4/DF4 US, Model Number DTBB1QQ;  Implantable Cardioverter Defibrillators",
  "description": "FDA recall Z-1744-2023 — Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) is recalling CRT-D DTBB1QQ VIVA QUAD S IS4/DF4 US, Model Number DTBB1QQ;  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",
    "url": "https://open.fda.gov/apis/drug/enforcement/",
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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-1744-2023&lang=eng",
  "about": {
    "@type": "schema:MedicalDevice",
    "name": "CRT-D DTBB1QQ VIVA QUAD S IS4/DF4 US, Model Number DTBB1QQ;  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-1744-2023/enforcement-record",
      "@type": "schema:Claim",
      "name": "FDA recall Z-1744-2023: Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) is recalling CRT-D DTBB1QQ VIVA QUAD S IS4/DF4 US, Model Number DTBB1QQ;  Implantable Cardioverter Defibrillators",
      "text": "The FDA logged enforcement record Z-1744-2023: Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) is voluntarily recalling CRT-D DTBB1QQ VIVA QUAD S IS4/DF4 US, Model Number DTBB1QQ;  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 00643169720145, Lot Serial Numbers:  BLK205268H, BLK205272H, BLK205461H, BLK205544H, BLK205582H, BLK205328H, BLK205358H, BLK205475H, BLK205492H, BLK205304H, BLK205346H, BLK205364H, BLK205269H, BLK205352H, BLK205349H, BLK205400H, BLK205432H, BLK205451H, BLK205309H, BLK205310H, BLK205315H, BLK205514H, BLK205424H, BLK205466H, BLK205513H, BLK205279H, BLK205504H, BLK205314H, BLK205376H, BLK205377H, BLK205394H, BLK205443H, BLK205444H, BLK205275H, BLK205284H, BLK205285H, BLK205287H, BLK205298H, BLK205312H, BLK205379H, BLK205389H, BLK205406H, BLK205415H, BLK205419H, BLK205429H, BLK205431H, BLK205435H, BLK205464H, BLK205471H, BLK205478H, BLK205512H, BLK205517H, BLK205524H, BLK205528H, BLK205541H, BLK205427H, BLK205289H, BLK205387H, BLK205566H, BLK205374H, BLK205508H, BLK205369H, BLK205395H, BLK205311H, BLK205405H, BLK205445H, BLK205472H, BLK205522H, BLK205523H, BLK205531H, BLK205537H, BLK205554H, BLK205450H, BLK205583H, BLK205166H, BLK205286H, BLK205296H, BLK205307H, BLK205329H, BLK205371H, BLK205372H, BLK205458H, BLK205494H, BLK205498H, BLK205570H, BLK205341H, BLK205305H, BLK205317H, BLK205354H, BLK205468H, BLK205469H, BLK205574H, BLK205345H, BLK205363H, BLK205378H, BLK205539H, BLK205534H, BLK205535H, BLK205536H, BLK205295H, BLK205308H, BLK205323H, BLK205335H, BLK205428H, BLK205434H, BLK205440H, BLK205448H, BLK205449H, BLK205489H, BLK205457H, BLK205306H, BLK205276H, BLK205403H, BLK205326H, BLK205330H, BLK205299H, BLK205483H, BLK205565H, BLK205459H, BLK205259H, BLK205292H, BLK205516H, BLK205408H, BLK205418H, BLK205476H, BLK205409H, BLK205548H, BLK205525H, BLK205511H, BLK205293H, BLK205370H, BLK205380H, BLK205433H, BLK205506H, BLK205288H, BLK205327H, BLK205396H, BLK205465H, BLK205588H, BLK205302H, BLK205367H, BLK205375H, BLK205399H, BLK205454H, BLK205470H, BLK205291H, BLK205482H, BLK205351H, BLK205324H, BLK205520H, BLK205273H, BLK205496H, BLK205366H, BLK205262H, BLK205313H, BLK205331H, BLK205493H, BLK205368H, BLK205301H, BLK205386H, BLK205390H, BLK205401H, BLK205402H, BLK205417H, BLK205258H, BLK205260H, BLK205267H, BLK205320H, BLK205357H, BLK205410H, BLK205412H, BLK205515H, BLK205584H, BLK205263H, BLK205348H, BLK205334H, BLK205337H, BLK205338H, BLK205373H, BLK205384H, BLK205481H, BLK205491H, BLK205526H, BLK205527H, BLK205530H, BLK205532H, BLK205575H, BLK205577H, BLK205578H, BLK205447H, BLK205509H, BLK205414H, BLK205501H. A RECORDED FDA enforcement action (occurred=true).",
      "claimType": "official_fact",
      "reviewStatus": "current",
      "commercialInfluence": false,
      "epistemicStatus": {
        "occurred": true,
        "supported": 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-1744-2023&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-1744-2023&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-1744-2023/fda-classification",
      "@type": "schema:Claim",
      "name": "FDA classified recall Z-1744-2023 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-1744-2023&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-1744-2023&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-1744-2023/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-1744-2023",
      "numberOfItems": 9,
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          "position": 1,
          "item": {
            "Field": "Recall number",
            "Value": "Z-1744-2023",
            "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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        {
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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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        {
          "@type": "schema:ListItem",
          "position": 7,
          "item": {
            "Field": "Initiated",
            "Value": "2023-05-10",
            "Status": "recorded"
          }
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          "position": 8,
          "item": {
            "Field": "Lot/code info",
            "Value": "GTIN 00643169720145, Lot Serial Numbers:  BLK205268H, BLK205272H, BLK205461H, BLK205544H, BLK205582H, BLK205328H, BLK205358H, BLK205475H, BLK205492H, BLK205304H, BLK205346H, BLK205364H, BLK205269H, BLK205352H, BLK205349H, BLK205400H, BLK205432H, BLK205451H, BLK205309H, BLK205310H, BLK205315H, BLK205514H, BLK205424H, BLK205466H, BLK205513H, BLK205279H, BLK205504H, BLK205314H, BLK205376H, BLK205377H, BLK205394H, BLK205443H, BLK205444H, BLK205275H, BLK205284H, BLK205285H, BLK205287H, BLK205298H, BLK205312H, BLK205379H, BLK205389H, BLK205406H, BLK205415H, BLK205419H, BLK205429H, BLK205431H, BLK205435H, BLK205464H, BLK205471H, BLK205478H, BLK205512H, BLK205517H, BLK205524H, BLK205528H, BLK205541H, BLK205427H, BLK205289H, BLK205387H, BLK205566H, BLK205374H, BLK205508H, BLK205369H, BLK205395H, BLK205311H, BLK205405H, BLK205445H, BLK205472H, BLK205522H, BLK205523H, BLK205531H, BLK205537H, BLK205554H, BLK205450H, BLK205583H, BLK205166H, BLK205286H, BLK205296H, BLK205307H, BLK205329H, BLK205371H, BLK205372H, BLK205458H, BLK205494H, BLK205498H, BLK205570H, BLK205341H, BLK205305H, BLK205317H, BLK205354H, BLK205468H, BLK205469H, BLK205574H, BLK205345H, BLK205363H, BLK205378H, BLK205539H, BLK205534H, BLK205535H, BLK205536H, BLK205295H, BLK205308H, BLK205323H, BLK205335H, BLK205428H, BLK205434H, BLK205440H, BLK205448H, BLK205449H, BLK205489H, BLK205457H, BLK205306H, BLK205276H, BLK205403H, BLK205326H, BLK205330H, BLK205299H, BLK205483H, BLK205565H, BLK205459H, BLK205259H, BLK205292H, BLK205516H, BLK205408H, BLK205418H, BLK205476H, BLK205409H, BLK205548H, BLK205525H, BLK205511H, BLK205293H, BLK205370H, BLK205380H, BLK205433H, BLK205506H, BLK205288H, BLK205327H, BLK205396H, BLK205465H, BLK205588H, BLK205302H, BLK205367H, BLK205375H, BLK205399H, BLK205454H, BLK205470H, BLK205291H, BLK205482H, BLK205351H, BLK205324H, BLK205520H, BLK205273H, BLK205496H, BLK205366H, BLK205262H, BLK205313H, BLK205331H, BLK205493H, BLK205368H, BLK205301H, BLK205386H, BLK205390H, BLK205401H, BLK205402H, BLK205417H, BLK205258H, BLK205260H, BLK205267H, BLK205320H, BLK205357H, BLK205410H, BLK205412H, BLK205515H, BLK205584H, BLK205263H, BLK205348H, BLK205334H, BLK205337H, BLK205338H, BLK205373H, BLK205384H, BLK205481H, BLK205491H, BLK205526H, BLK205527H, BLK205530H, BLK205532H, BLK205575H, BLK205577H, BLK205578H, BLK205447H, BLK205509H, BLK205414H, BLK205501H",
            "Status": "recorded"
          }
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          "item": {
            "Field": "Distribution pattern",
            "Value": "US Nationwide - Worldwide Distribution",
            "Status": "recorded"
          }
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}