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  "name": "CRT-D DTBA1Q1 VIVA QUAD XT IS4/DF1 US, Model Number DTBA1Q1;  Implantable Cardioverter Defibrillators",
  "description": "FDA recall Z-1732-2023 — Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) is recalling CRT-D DTBA1Q1 VIVA QUAD XT IS4/DF1 US, Model Number DTBA1Q1;  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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      "name": "FDA recall Z-1732-2023: Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) is recalling CRT-D DTBA1Q1 VIVA QUAD XT IS4/DF1 US, Model Number DTBA1Q1;  Implantable Cardioverter Defibrillators",
      "text": "The FDA logged enforcement record Z-1732-2023: Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) is voluntarily recalling CRT-D DTBA1Q1 VIVA QUAD XT IS4/DF1 US, Model Number DTBA1Q1;  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 00643169720190, Lot Serial Numbers:  BLD212440H, BLD212962H, BLD212366H, BLD212449H, BLD212473H, BLD212554H, BLD212653H, BLD212675H, BLD212791H, BLD212822H, BLD212902H, BLD212926H, BLD213003H, BLD213009H, BLD212351H, BLD212699H, BLD212811H, BLD212406H, BLD212432H, BLD212306H, BLD212443H, BLD212455H, BLD212472H, BLD212600H, BLD212644H, BLD212839H, BLD212920H, BLD212943H, BLD212349H, BLD212311H, BLD212708H, BLD212781H, BLD212834H, BLD212521H, BLD212566H, BLD212628H, BLD212648H, BLD212782H, BLD212883H, BLD213061H, BLD212483H, BLD212487H, BLD213006H, BLD212452H, BLD212752H, BLD213012H, BLD212357H, BLD212333H, BLD212570H, BLD212638H, BLD212709H, BLD212830H, BLD212915H, BLD212953H, BLD212984H, BLD212996H, BLD213030H, BLD213041H, BLD212586H, BLD212459H, BLD212721H, BLD212843H, BLD213039H, BLD212917H, BLD212427H, BLD211868H, BLD212522H, BLD212412H, BLD212413H, BLD212415H, BLD212416H, BLD212418H, BLD212767H, BLD212842H, BLD212878H, BLD212879H, BLD212898H, BLD212909H, BLD213072H, BLD212376H, BLD212702H, BLD212556H, BLD211866H, BLD212723H, BLD211867H, BLD212688H, BLD212565H, BLD212615H, BLD212627H, BLD212732H, BLD212785H, BLD212912H, BLD212919H, BLD212951H, BLD212993H, BLD213011H, BLD213015H, BLD213032H, BLD213042H, BLD213052H, BLD213053H, BLD212774H, BLD212783H, BLD213035H, BLD213049H, BLD212835H, BLD212538H, BLD212411H, BLD212809H, BLD212925H, BLD213060H, BLD212358H, BLD212762H, BLD212813H, BLD212578H, BLD212625H, BLD212626H, BLD212552H, BLD212729H, BLD212368H, BLD212423H, BLD212425H, BLD212454H, BLD212512H, BLD212561H, BLD212607H, BLD212617H, BLD212743H, BLD212770H, BLD212772H, BLD212820H, BLD212862H, BLD212867H, BLD212884H, BLD212903H, BLD212904H, BLD212942H, BLD212975H, BLD212979H, BLD212981H, BLD212982H, BLD212985H, BLD212987H, BLD212988H, BLD212991H, BLD212994H, BLD212995H, BLD213070H, BLD212560H, BLD212551H, BLD212480H, BLD212481H, BLD212520H, BLD212341H, BLD212350H, BLD212553H, BLD212611H, BLD212649H, BLD212334H, BLD212871H, BLD212682H, BLD212864H, BLD212737H, BLD212798H, BLD212690H, BLD212776H, BLD212622H, BLD212390H, BLD212363H, BLD212514H, BLD213021H, BLD213066H, BLD212761H, BLD212652H, BLD212500H, BLD212356H, BLD212456H, BLD212478H, BLD212833H, BLD212840H, BLD212373H, BLD212868H, BLD213036H, BLD212397H, BLD212567H, BLD212624H, BLD212686H, BLD212745H, BLD212803H, BLD212817H, BLD212893H, BLD212934H, BLD212964H, BLD212992H, BLD213008H, BLD213004H, BLD212526H, BLD212704H, BLD212345H, BLD212692H, BLD212826H, BLD212844H, BLD212977H, BLD212346H, BLD212461H, BLD212395H, BLD212404H, BLD212890H, BLD212408H, BLD212410H, BLD212575H, BLD212661H, BLD212736H, BLD212636H, BLD212447H, BLD212855H, BLD212313H, BLD212444H, BLD212493H, BLD212498H, BLD212501H, BLD212683H, BLD212471H, BLD213062H, BLD212431H, BLD212534H, BLD212539H, BLD212576H, BLD212548H, BLD212620H, BLD212664H, BLD212960H, BLD212535H, BLD212577H, BLD212931H, BLD213063H, BLD212513H, BLD212598H, BLD212712H, BLD212779H, BLD212841H, BLD212876H, BLD212446H, BLD212786H, BLD212711H, BLD212557H, BLD213001H, BLD212451H, BLD212790H, BLD212465H, BLD212564H, BLD212858H, BLD212886H, BLD212583H, BLD212515H, BLD212974H, BLD212829H, BLD212375H, BLD212573H, BLD212632H, BLD212771H, BLD212314H, BLD212354H, BLD212725H, BLD212746H, BLD211870H, BLD212680H, BLD212892H, BLD213034H, BLD212764H, BLD212806H, BLD212718H, BLD212983H, BLD212703H, BLD212726H, BLD212787H, BLD212804H, BLD212927H, BLD213084H, BLD212589H, BLD212305H, BLD212525H, BLD212705H, BLD212735H, BLD212795H, BLD212838H, BLD212845H, BLD213045H, BLD212837H, BLD213075H, BLD212352H, BLD212353H, BLD212380H, BLD212511H, BLD212307H, BLD212719H, BLD212312H, BLD212747H, BLD212792H, BLD213031H, BLD213090H, BLD212330H, BLD212439H, BLD212579H, BLD212630H, BLD212631H, BLD212634H, BLD212821H, BLD212986H, BLD212673H, BLD212655H, BLD212657H, BLD212658H, BLD212659H, BLD212674H, BLD212685H, BLD212695H, BLD212710H, BLD212714H, BLD212733H, BLD212734H, BLD212740H, BLD212728H, BLD212882H, BLD212687H, BLD212731H, BLD212827H, BLD212359H, BLD212533H, BLD212662H, BLD212645H, BLD212751H, BLD212753H, BLD212857H, BLD212972H, BLD212784H, BLD212796H, BLD212907H, BLD212793H, BLD212918H, BLD212361H, BLD212880H, BLD212640H, BLD213019H, BLD212437H, BLD212318H, BLD213005H, BLD212691H, BLD212315H, BLD212805H, BLD213026H, BLD212372H, BLD212309H, BLD212327H, BLD212340H, BLD212801H, BLD212929H, BLD212952H, BLD213085H, BLD212384H, BLD212872H, BLD212958H, BLD212959H, BLD213083H, BLD212466H, BLD213037H, BLD213087H, BLD212759H, BLD212989H, BLD212997H, BLD213043H, BLD212684H, BLD212955H. A RECORDED FDA enforcement action (occurred=true).",
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        "sourceUrl": "https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?action=select&recall_number=Z-1732-2023&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-1732-2023&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-1732-2023/fda-classification",
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      "name": "FDA classified recall Z-1732-2023 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.",
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        "value": "Class I",
        "adjudicator": {
          "name": "U.S. FDA recall classification (openFDA enforcement)",
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        }
      },
      "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-1732-2023/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",
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        "supported": true,
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        "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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            "Value": "Ongoing — the recall is still being carried out.",
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            "Value": "Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)",
            "Status": "recorded"
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            "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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            "Field": "Initiated",
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          "item": {
            "Field": "Lot/code info",
            "Value": "GTIN 00643169720190, Lot Serial Numbers:  BLD212440H, BLD212962H, BLD212366H, BLD212449H, BLD212473H, BLD212554H, BLD212653H, BLD212675H, BLD212791H, BLD212822H, BLD212902H, BLD212926H, BLD213003H, BLD213009H, BLD212351H, BLD212699H, BLD212811H, BLD212406H, BLD212432H, BLD212306H, BLD212443H, BLD212455H, BLD212472H, BLD212600H, BLD212644H, BLD212839H, BLD212920H, BLD212943H, BLD212349H, BLD212311H, BLD212708H, BLD212781H, BLD212834H, BLD212521H, BLD212566H, BLD212628H, BLD212648H, BLD212782H, BLD212883H, BLD213061H, BLD212483H, BLD212487H, BLD213006H, BLD212452H, BLD212752H, BLD213012H, BLD212357H, BLD212333H, BLD212570H, BLD212638H, BLD212709H, BLD212830H, BLD212915H, BLD212953H, BLD212984H, BLD212996H, BLD213030H, BLD213041H, BLD212586H, BLD212459H, BLD212721H, BLD212843H, BLD213039H, BLD212917H, BLD212427H, BLD211868H, BLD212522H, BLD212412H, BLD212413H, BLD212415H, BLD212416H, BLD212418H, BLD212767H, BLD212842H, BLD212878H, BLD212879H, BLD212898H, BLD212909H, BLD213072H, BLD212376H, BLD212702H, BLD212556H, BLD211866H, BLD212723H, BLD211867H, BLD212688H, BLD212565H, BLD212615H, BLD212627H, BLD212732H, BLD212785H, BLD212912H, BLD212919H, BLD212951H, BLD212993H, BLD213011H, BLD213015H, BLD213032H, BLD213042H, BLD213052H, BLD213053H, BLD212774H, BLD212783H, BLD213035H, BLD213049H, BLD212835H, BLD212538H, BLD212411H, BLD212809H, BLD212925H, BLD213060H, BLD212358H, BLD212762H, BLD212813H, BLD212578H, BLD212625H, BLD212626H, BLD212552H, BLD212729H, BLD212368H, BLD212423H, BLD212425H, BLD212454H, BLD212512H, BLD212561H, BLD212607H, BLD212617H, BLD212743H, BLD212770H, BLD212772H, BLD212820H, BLD212862H, BLD212867H, BLD212884H, BLD212903H, BLD212904H, BLD212942H, BLD212975H, BLD212979H, BLD212981H, BLD212982H, BLD212985H, BLD212987H, BLD212988H, BLD212991H, BLD212994H, BLD212995H, BLD213070H, BLD212560H, BLD212551H, BLD212480H, BLD212481H, BLD212520H, BLD212341H, BLD212350H, BLD212553H, BLD212611H, BLD212649H, BLD212334H, BLD212871H, BLD212682H, BLD212864H, BLD212737H, BLD212798H, BLD212690H, BLD212776H, BLD212622H, BLD212390H, BLD212363H, BLD212514H, BLD213021H, BLD213066H, BLD212761H, BLD212652H, BLD212500H, BLD212356H, BLD212456H, BLD212478H, BLD212833H, BLD212840H, BLD212373H, BLD212868H, BLD213036H, BLD212397H, BLD212567H, BLD212624H, BLD212686H, BLD212745H, BLD212803H, BLD212817H, BLD212893H, BLD212934H, BLD212964H, BLD212992H, BLD213008H, BLD213004H, BLD212526H, BLD212704H, BLD212345H, BLD212692H, BLD212826H, BLD212844H, BLD212977H, BLD212346H, BLD212461H, BLD212395H, BLD212404H, BLD212890H, BLD212408H, BLD212410H, BLD212575H, BLD212661H, BLD212736H, BLD212636H, BLD212447H, BLD212855H, BLD212313H, BLD212444H, BLD212493H, BLD212498H, BLD212501H, BLD212683H, BLD212471H, BLD213062H, BLD212431H, BLD212534H, BLD212539H, BLD212576H, BLD212548H, BLD212620H, BLD212664H, BLD212960H, BLD212535H, BLD212577H, BLD212931H, BLD213063H, BLD212513H, BLD212598H, BLD212712H, BLD212779H, BLD212841H, BLD212876H, BLD212446H, BLD212786H, BLD212711H, BLD212557H, BLD213001H, BLD212451H, BLD212790H, BLD212465H, BLD212564H, BLD212858H, BLD212886H, BLD212583H, BLD212515H, BLD212974H, BLD212829H, BLD212375H, BLD212573H, BLD212632H, BLD212771H, BLD212314H, BLD212354H, BLD212725H, BLD212746H, BLD211870H, BLD212680H, BLD212892H, BLD213034H, BLD212764H, BLD212806H, BLD212718H, BLD212983H, BLD212703H, BLD212726H, BLD212787H, BLD212804H, BLD212927H, BLD213084H, BLD212589H, BLD212305H, BLD212525H, BLD212705H, BLD212735H, BLD212795H, BLD212838H, BLD212845H, BLD213045H, BLD212837H, BLD213075H, BLD212352H, BLD212353H, BLD212380H, BLD212511H, BLD212307H, BLD212719H, BLD212312H, BLD212747H, BLD212792H, BLD213031H, BLD213090H, BLD212330H, BLD212439H, BLD212579H, BLD212630H, BLD212631H, BLD212634H, BLD212821H, BLD212986H, BLD212673H, BLD212655H, BLD212657H, BLD212658H, BLD212659H, BLD212674H, BLD212685H, BLD212695H, BLD212710H, BLD212714H, BLD212733H, BLD212734H, BLD212740H, BLD212728H, BLD212882H, BLD212687H, BLD212731H, BLD212827H, BLD212359H, BLD212533H, BLD212662H, BLD212645H, BLD212751H, BLD212753H, BLD212857H, BLD212972H, BLD212784H, BLD212796H, BLD212907H, BLD212793H, BLD212918H, BLD212361H, BLD212880H, BLD212640H, BLD213019H, BLD212437H, BLD212318H, BLD213005H, BLD212691H, BLD212315H, BLD212805H, BLD213026H, BLD212372H, BLD212309H, BLD212327H, BLD212340H, BLD212801H, BLD212929H, BLD212952H, BLD213085H, BLD212384H, BLD212872H, BLD212958H, BLD212959H, BLD213083H, BLD212466H, BLD213037H, BLD213087H, BLD212759H, BLD212989H, BLD212997H, BLD213043H, BLD212684H, BLD212955H",
            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 9,
          "item": {
            "Field": "Distribution pattern",
            "Value": "US Nationwide - Worldwide Distribution",
            "Status": "recorded"
          }
        }
      ]
    }
  ]
}