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  "name": "CRT-D DTBB2D4 VIVA S IS1/DF4 INTL, Model Number DTBB2D4;  Implantable Cardioverter Defibrillators",
  "description": "FDA recall Z-1746-2023 — Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) is recalling CRT-D DTBB2D4 VIVA S IS1/DF4 INTL, Model Number DTBB2D4;  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": "CRT-D DTBB2D4 VIVA S IS1/DF4 INTL, Model Number DTBB2D4;  Implantable Cardioverter Defibrillators",
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      "name": "FDA recall Z-1746-2023: Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) is recalling CRT-D DTBB2D4 VIVA S IS1/DF4 INTL, Model Number DTBB2D4;  Implantable Cardioverter Defibrillators",
      "text": "The FDA logged enforcement record Z-1746-2023: Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) is voluntarily recalling CRT-D DTBB2D4 VIVA S IS1/DF4 INTL, Model Number DTBB2D4;  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 00643169720299, Lot Serial Numbers;  BLR602282S, BLR602271S, BLR602274S, BLR602363S, BLR602366S, BLR602278S, BLR602289S, BLR602365S, BLR602238S, BLR602293S, BLR602325S, BLR602332S, BLR602333S, BLR602334S, BLR602336S, BLR602337S, BLR602340S, BLR602353S, BLR602360S, BLR602361S, BLR602356S, BLR602236S, BLR602237S, BLR602290S, BLR602296S, BLR602306S, BLR602338S, BLR602341S, BLR602358S, BLR602378S, BLR602335S, BLR602339S, BLR602359S, BLR602308S, BLR602328S, BLR602330S, BLR602331S, BLR602352S, BLR602357S, BLR602390S, BLR602269S, BLR602381S, BLR602382S, BLR602383S, BLR602384S, BLR602387S, BLR602398S, BLR602394S, BLR602395S, BLR602385S, BLR602386S, BLR602388S, BLR602397S, BLR602379S, BLR602380S, BLR602389S, BLR602362S, BLR602377S;   GTIN 00643169980112, Lot Serial Numbers:  BLR602821S, BLR602777S, BLR602490S, BLR602342S, BLR602492S, BLR602425S, BLR602408S, BLR602430S, BLR602515S, BLR602516S, BLR602518S, BLR602520S, BLR602530S, BLR602531S, BLR602534S, BLR602535S, 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BLR602449S, BLR602461S, BLR602465S, BLR602466S, BLR602468S, BLR602479S, BLR602481S, BLR602519S, BLR602521S, BLR602523S, BLR602526S, BLR602527S, BLR602529S, BLR602532S, BLR602533S, BLR602566S, BLR602616S, BLR602728S, BLR602438S, BLR602460S, BLR602495S, BLR602570S, BLR602464S, BLR602497S, BLR602525S, BLR602439S, BLR602467S, BLR602494S, BLR602517S, BLR602444S, BLR602469S, BLR602489S, BLR602524S, BLR602498S, BLR602522S, BLR602528S, BLR602538S, BLR602750S, BLR602772S, BLR602443S, BLR602482S, BLR602571S, BLR602586S, BLR602652S, BLR602664S, BLR602717S, BLR602718S, BLR602732S, BLR602740S, BLR602764S, BLR602699S, BLR602700S, BLR602701S, BLR602722S, BLR602744S, BLR602745S, BLR602582S, BLR602583S, BLR602809S, BLR602683S, BLR602737S, BLR602738S, BLR602801S, BLR602564S, BLR602681S, BLR602724S, BLR602726S, BLR602731S, BLR602765S, BLR602815S, BLR602565S, BLR602624S, BLR602813S, BLR602811S, BLR602580S, BLR602808S, BLR602762S, BLR602735S, BLR602677S, BLR602457S, BLR602661S, BLR602643S, BLR602653S, BLR602662S, BLR602630S, BLR602679S, BLR602680S, BLR602723S, BLR602729S, BLR602503S, BLR602510S, BLR602512S, BLR602421S, BLR602577S, BLR602440S, BLR602441S, BLR602442S, BLR602452S, BLR602453S, BLR602454S, BLR602572S, BLR602573S, BLR602592S, BLR602593S, BLR602594S, BLR602599S, BLR602622S, BLR602626S, BLR602627S, BLR602631S, BLR602634S, BLR602635S, BLR602636S, BLR602637S, BLR602641S, BLR602642S, BLR602651S, BLR602654S, BLR602655S, BLR602656S, BLR602657S, BLR602658S, BLR602666S, BLR602671S, BLR602673S, BLR602685S, BLR602686S, BLR602689S, BLR602690S, BLR602692S, BLR602694S, BLR602698S, BLR602704S, BLR602714S, BLR602715S, BLR602719S, BLR602727S, BLR602741S, BLR602742S, BLR602743S, BLR602746S, BLR602747S, BLR602748S, BLR602749S, BLR602755S, BLR602758S, BLR602767S, BLR602806S, BLR602807S, BLR602705S, BLR602581S, BLR602730S, BLR602628S, BLR602629S, BLR602674S, BLR602675S, BLR602695S, BLR602707S, BLR602804S, BLR602814S, BLR602816S, BLR602578S, BLR602455S, BLR602614S, BLR602663S, BLR602761S, BLR602771S, BLR602798S, BLR602799S, BLR602800S, BLR602619S, BLR602620S, BLR602621S, BLR602650S, BLR602660S, BLR602734S, BLR602766S, BLR602768S, BLR602812S, BLR602667S, BLR602708S, BLR602473S, BLR602477S, BLR602649S, BLR602591S, BLR602668S, BLR602576S, BLR602720S, BLR602823S, BLR602611S, BLR602420S, BLR602563S, BLR602721S, BLR602623S, BLR602625S, BLR602702S, BLR602703S, BLR602709S, BLR602458S, BLR602691S, BLR602612S, BLR602676S, BLR602725S, BLR602588S, BLR602805S, BLR602513S, BLR602474S, BLR602475S, BLR602478S, BLR602483S, BLR602484S, BLR602485S, BLR602486S, BLR602487S, BLR602491S, BLR602499S, BLR602500S, BLR602501S, BLR602502S, BLR602504S, BLR602505S, BLR602506S, BLR602508S, BLR602509S, BLR602511S, BLR602541S, BLR602543S, BLR602547S, BLR602549S, BLR602551S, BLR602553S, BLR602559S, BLR602561S, BLR602562S, BLR602568S, BLR602569S, BLR602574S, BLR602575S, BLR602579S, BLR602584S, BLR602585S, BLR602589S, BLR602590S, BLR602595S, BLR602596S, BLR602597S, BLR602598S, BLR602600S, BLR602602S, BLR602603S, BLR602605S, BLR602607S, BLR602608S, BLR602609S, BLR602610S, BLR602613S, BLR602615S, BLR602617S, BLR602659S, BLR602646S, BLR602693S, BLR602733S, BLR602774S, BLR602775S, BLR602776S, BLR602786S, BLR602802S, BLR602716S;  GTIN 00763000612283, Lot Serial Numbers:  BLR602824S, BLR602825S, BLR602826S, BLR602830S, BLR602831S, BLR602832S, BLR602833S, BLR602834S, BLR602835S, BLR602836S. A RECORDED FDA enforcement action (occurred=true).",
      "claimType": "official_fact",
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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-1746-2023&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-1746-2023&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-1746-2023/fda-classification",
      "@type": "schema:Claim",
      "name": "FDA classified recall Z-1746-2023 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-1746-2023&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-1746-2023&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-1746-2023/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."
    }
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      "name": "FDA recall details — Z-1746-2023",
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            "Status": "recorded"
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            "Value": "Devices",
            "Status": "recorded"
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          "item": {
            "Field": "Classification",
            "Value": "Class I",
            "Status": "determination"
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          "item": {
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            "Value": "Ongoing — the recall is still being carried out.",
            "Status": "recorded"
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          "item": {
            "Field": "Recalling firm",
            "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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        },
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          "item": {
            "Field": "Initiated",
            "Value": "2023-05-10",
            "Status": "recorded"
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          "item": {
            "Field": "Lot/code info",
            "Value": "GTIN 00643169720299, Lot Serial Numbers;  BLR602282S, BLR602271S, BLR602274S, BLR602363S, BLR602366S, BLR602278S, BLR602289S, BLR602365S, BLR602238S, BLR602293S, BLR602325S, BLR602332S, BLR602333S, BLR602334S, BLR602336S, BLR602337S, BLR602340S, BLR602353S, BLR602360S, BLR602361S, BLR602356S, BLR602236S, BLR602237S, BLR602290S, BLR602296S, BLR602306S, BLR602338S, BLR602341S, BLR602358S, BLR602378S, BLR602335S, BLR602339S, BLR602359S, BLR602308S, BLR602328S, BLR602330S, BLR602331S, BLR602352S, BLR602357S, BLR602390S, BLR602269S, BLR602381S, BLR602382S, BLR602383S, BLR602384S, BLR602387S, BLR602398S, BLR602394S, BLR602395S, BLR602385S, BLR602386S, BLR602388S, BLR602397S, BLR602379S, BLR602380S, BLR602389S, BLR602362S, BLR602377S;   GTIN 00643169980112, Lot Serial Numbers:  BLR602821S, BLR602777S, BLR602490S, BLR602342S, BLR602492S, BLR602425S, BLR602408S, BLR602430S, BLR602515S, BLR602516S, BLR602518S, BLR602520S, BLR602530S, BLR602531S, BLR602534S, BLR602535S, BLR602537S, BLR602540S, BLR602542S, BLR602544S, BLR602545S, BLR602546S, BLR602548S, BLR602550S, BLR602552S, BLR602554S, BLR602555S, BLR602587S, BLR602632S, BLR602633S, BLR602638S, BLR602639S, BLR602640S, BLR602644S, BLR602645S, BLR602647S, BLR602669S, BLR602670S, BLR602672S, BLR602682S, BLR602710S, BLR602711S, BLR602751S, BLR602752S, BLR602753S, BLR602754S, BLR602760S, BLR602763S, BLR602770S, BLR602773S, BLR602787S, BLR602788S, BLR602789S, BLR602790S, BLR602791S, BLR602792S, BLR602793S, BLR602794S, BLR602795S, BLR602796S, BLR602797S, BLR602818S, BLR602820S, BLR602476S, BLR602480S, BLR602514S, BLR602539S, BLR602556S, BLR602558S, BLR602567S, BLR602601S, BLR602648S, BLR602665S, BLR602678S, BLR602684S, BLR602687S, BLR602688S, BLR602706S, BLR602713S, BLR602756S, BLR602757S, BLR602784S, BLR602557S, BLR602344S, BLR602321S, BLR602343S, BLR602423S, BLR602319S, BLR602320S, BLR602345S, BLR602346S, BLR602426S, BLR602427S, BLR602436S, BLR602437S, BLR602445S, BLR602446S, BLR602447S, BLR602448S, BLR602449S, BLR602461S, BLR602465S, BLR602466S, BLR602468S, BLR602479S, BLR602481S, BLR602519S, BLR602521S, BLR602523S, BLR602526S, BLR602527S, BLR602529S, BLR602532S, BLR602533S, BLR602566S, BLR602616S, BLR602728S, BLR602438S, BLR602460S, BLR602495S, BLR602570S, BLR602464S, BLR602497S, BLR602525S, BLR602439S, BLR602467S, BLR602494S, BLR602517S, BLR602444S, BLR602469S, BLR602489S, BLR602524S, BLR602498S, BLR602522S, BLR602528S, BLR602538S, BLR602750S, BLR602772S, BLR602443S, BLR602482S, BLR602571S, BLR602586S, BLR602652S, BLR602664S, BLR602717S, BLR602718S, BLR602732S, BLR602740S, BLR602764S, BLR602699S, BLR602700S, BLR602701S, BLR602722S, BLR602744S, BLR602745S, BLR602582S, BLR602583S, BLR602809S, BLR602683S, BLR602737S, BLR602738S, BLR602801S, BLR602564S, BLR602681S, BLR602724S, BLR602726S, BLR602731S, BLR602765S, BLR602815S, BLR602565S, BLR602624S, BLR602813S, BLR602811S, BLR602580S, BLR602808S, BLR602762S, BLR602735S, BLR602677S, BLR602457S, BLR602661S, BLR602643S, BLR602653S, BLR602662S, BLR602630S, BLR602679S, BLR602680S, BLR602723S, BLR602729S, BLR602503S, BLR602510S, BLR602512S, BLR602421S, BLR602577S, BLR602440S, BLR602441S, BLR602442S, BLR602452S, BLR602453S, BLR602454S, BLR602572S, BLR602573S, BLR602592S, BLR602593S, BLR602594S, BLR602599S, BLR602622S, BLR602626S, BLR602627S, BLR602631S, BLR602634S, BLR602635S, BLR602636S, BLR602637S, BLR602641S, BLR602642S, BLR602651S, BLR602654S, BLR602655S, BLR602656S, BLR602657S, BLR602658S, BLR602666S, BLR602671S, BLR602673S, BLR602685S, BLR602686S, BLR602689S, BLR602690S, BLR602692S, BLR602694S, BLR602698S, BLR602704S, BLR602714S, BLR602715S, BLR602719S, BLR602727S, BLR602741S, BLR602742S, BLR602743S, BLR602746S, BLR602747S, BLR602748S, BLR602749S, BLR602755S, BLR602758S, BLR602767S, BLR602806S, BLR602807S, BLR602705S, BLR602581S, BLR602730S, BLR602628S, BLR602629S, BLR602674S, BLR602675S, BLR602695S, BLR602707S, BLR602804S, BLR602814S, BLR602816S, BLR602578S, BLR602455S, BLR602614S, BLR602663S, BLR602761S, BLR602771S, BLR602798S, BLR602799S, BLR602800S, BLR602619S, BLR602620S, BLR602621S, BLR602650S, BLR602660S, BLR602734S, BLR602766S, BLR602768S, BLR602812S, BLR602667S, BLR602708S, BLR602473S, BLR602477S, BLR602649S, BLR602591S, BLR602668S, BLR602576S, BLR602720S, BLR602823S, BLR602611S, BLR602420S, BLR602563S, BLR602721S, BLR602623S, BLR602625S, BLR602702S, BLR602703S, BLR602709S, BLR602458S, BLR602691S, BLR602612S, BLR602676S, BLR602725S, BLR602588S, BLR602805S, BLR602513S, BLR602474S, BLR602475S, BLR602478S, BLR602483S, BLR602484S, BLR602485S, BLR602486S, BLR602487S, BLR602491S, BLR602499S, BLR602500S, BLR602501S, BLR602502S, BLR602504S, BLR602505S, BLR602506S, BLR602508S, BLR602509S, BLR602511S, BLR602541S, BLR602543S, BLR602547S, BLR602549S, BLR602551S, BLR602553S, BLR602559S, BLR602561S, BLR602562S, BLR602568S, BLR602569S, BLR602574S, BLR602575S, BLR602579S, BLR602584S, BLR602585S, BLR602589S, BLR602590S, BLR602595S, BLR602596S, BLR602597S, BLR602598S, BLR602600S, BLR602602S, BLR602603S, BLR602605S, BLR602607S, BLR602608S, BLR602609S, BLR602610S, BLR602613S, BLR602615S, BLR602617S, BLR602659S, BLR602646S, BLR602693S, BLR602733S, BLR602774S, BLR602775S, BLR602776S, BLR602786S, BLR602802S, BLR602716S;  GTIN 00763000612283, Lot Serial Numbers:  BLR602824S, BLR602825S, BLR602826S, BLR602830S, BLR602831S, BLR602832S, BLR602833S, BLR602834S, BLR602835S, BLR602836S",
            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 9,
          "item": {
            "Field": "Distribution pattern",
            "Value": "US Nationwide - Worldwide Distribution",
            "Status": "recorded"
          }
        }
      ]
    }
  ]
}