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  "name": "ICD-VR DVAB1D4 VISIA AF US DF4, Model Number DVAB1D4;  Implantable Cardioverter Defibrillators",
  "description": "FDA recall Z-1790-2023 — Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) is recalling ICD-VR DVAB1D4 VISIA AF US DF4, Model Number DVAB1D4;  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": "ICD-VR DVAB1D4 VISIA AF US DF4, Model Number DVAB1D4;  Implantable Cardioverter Defibrillators",
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      "name": "Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)"
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      "@type": "schema:Claim",
      "name": "FDA recall Z-1790-2023: Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) is recalling ICD-VR DVAB1D4 VISIA AF US DF4, Model Number DVAB1D4;  Implantable Cardioverter Defibrillators",
      "text": "The FDA logged enforcement record Z-1790-2023: Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) is voluntarily recalling ICD-VR DVAB1D4 VISIA AF US DF4, Model Number DVAB1D4;  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 00643169720626, Lot Serial Numbers:  BWP202537H, BWP202379H, BWP202439H, BWP202454H, BWP202474H, BWP202510H, BWP202522H, BWP202523H, BWP202252H, BWP202639H, BWP202514H, BWP202179H, BWP202398H, BWP202399H, BWP202554H, BWP202420H, BWP202447H, BWP202494H, BWP201863H, BWP202260H, BWP202324H, BWP202359H, BWP202432H, BWP202542H, BWP202643H, BWP202292H, BWP202297H, BWP202365H, BWP202366H, BWP202369H, BWP202549H, BWP202578H, BWP202213H, BWP202287H, BWP202471H, BWP202583H, BWP201864H, BWP202626H, BWP202358H, BWP202331H, BWP202306H, BWP202385H, BWP202272H, BWP202404H, BWP202434H, BWP202453H, BWP202553H, BWP202576H, BWP202586H, BWP202588H, BWP202598H, BWP202544H, BWP202159H, BWP202161H, BWP202162H, BWP202163H, BWP202164H, BWP202165H, BWP202561H, BWP202563H, BWP202467H, BWP202194H, BWP202238H, BWP202460H, BWP202497H, BWP202198H, BWP202532H, BWP202566H, BWP202536H, BWP202180H, BWP202402H, BWP202424H, BWP202429H, BWP202183H, BWP202279H, BWP202362H, BWP202363H, BWP202364H, BWP202496H, BWP202291H, BWP202189H, BWP202338H, BWP202273H, BWP202488H, BWP202573H, BWP202508H, BWP202587H, BWP202349H, BWP202466H, BWP202354H, BWP202376H, BWP202455H, BWP202612H, BWP201861H, BWP202188H, BWP202284H, BWP202309H, BWP202168H, BWP202334H, BWP202381H, BWP202303H, BWP202223H, BWP202409H, BWP202249H, BWP202173H, BWP202158H, BWP202635H, BWP202415H, BWP202438H, BWP202177H, BWP202315H, BWP202360H, BWP202372H, BWP202388H, BWP202451H, BWP202498H, BWP202500H, BWP202504H, BWP202507H, BWP202515H, BWP202525H, BWP202531H, BWP202584H, BWP202589H, BWP202290H, BWP202237H, BWP202330H, BWP201862H, BWP202199H, BWP202256H, BWP202396H, BWP202378H, BWP202368H, BWP202356H, BWP202459H, BWP202167H, BWP202380H, BWP202230H, BWP202400H, BWP202236H, BWP202335H, BWP202351H, BWP202539H, BWP202574H, BWP202575H, BWP202596H, BWP202633H, BWP202476H, BWP202478H, BWP202479H, BWP202480H, BWP202481H, BWP202482H, BWP202343H, BWP202206H, BWP202251H, BWP202345H, BWP202352H, BWP202386H, BWP202205H, BWP202433H, BWP202340H, BWP202556H, BWP202286H, BWP202234H, BWP202169H, BWP202259H, BWP202263H, BWP202214H, BWP202216H, BWP202220H, BWP202248H, BWP202310H, BWP202552H, BWP202597H, BWP202410H, BWP202240H, BWP202243H, BWP202328H, BWP202464H, BWP202568H, BWP202170H, BWP202411H, BWP202276H, BWP202221H, BWP202178H, BWP202538H, BWP202551H, BWP202174H, BWP202289H, BWP202483H, BWP202485H, BWP202486H, BWP202608H, BWP202232H, BWP202241H, BWP202245H, BWP202253H, BWP202264H, BWP202313H, BWP202323H, BWP202336H, BWP202339H, BWP202341H, BWP202346H, BWP202370H, BWP202383H, BWP202389H, BWP202393H, BWP202395H, BWP202423H, BWP202436H, BWP202441H, BWP202442H, BWP202445H, BWP202448H, BWP202463H, BWP202487H, BWP202492H, BWP202501H, BWP202509H, BWP202511H, BWP202512H, BWP202513H, BWP202517H, BWP202518H, BWP202533H, BWP202555H, BWP202572H, BWP202581H, BWP202590H, BWP202244H, BWP202427H, BWP202428H, BWP202591H, BWP202599H, BWP202624H, BWP202305H, BWP202565H, BWP202625H. A RECORDED FDA enforcement action (occurred=true).",
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        "value": "Devices recall, status Ongoing",
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          "name": "openFDA drug & device enforcement (recall) reports — U.S. FDA",
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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-1790-2023/fda-classification",
      "@type": "schema:Claim",
      "name": "FDA classified recall Z-1790-2023 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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      "reviewStatus": "current",
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        "source": "U.S. FDA recall classification (openFDA enforcement)",
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        "value": "Class I",
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          "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-1790-2023&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-1790-2023/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",
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        "source": "Atlas Commons L5 boundary (enforcement-action ≠ harm causation)",
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        "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": "Z-1790-2023",
            "Status": "recorded"
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            "Value": "Devices",
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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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          "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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          "item": {
            "Field": "Initiated",
            "Value": "2023-05-10",
            "Status": "recorded"
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          "item": {
            "Field": "Lot/code info",
            "Value": "GTIN 00643169720626, Lot Serial Numbers:  BWP202537H, BWP202379H, BWP202439H, BWP202454H, BWP202474H, BWP202510H, BWP202522H, BWP202523H, BWP202252H, BWP202639H, BWP202514H, BWP202179H, BWP202398H, BWP202399H, BWP202554H, BWP202420H, BWP202447H, BWP202494H, BWP201863H, BWP202260H, BWP202324H, BWP202359H, BWP202432H, BWP202542H, BWP202643H, BWP202292H, BWP202297H, BWP202365H, BWP202366H, BWP202369H, BWP202549H, BWP202578H, BWP202213H, BWP202287H, BWP202471H, BWP202583H, BWP201864H, BWP202626H, BWP202358H, BWP202331H, BWP202306H, BWP202385H, BWP202272H, BWP202404H, BWP202434H, BWP202453H, BWP202553H, BWP202576H, BWP202586H, BWP202588H, BWP202598H, BWP202544H, BWP202159H, BWP202161H, BWP202162H, BWP202163H, BWP202164H, BWP202165H, BWP202561H, BWP202563H, BWP202467H, BWP202194H, BWP202238H, BWP202460H, BWP202497H, BWP202198H, BWP202532H, BWP202566H, BWP202536H, BWP202180H, BWP202402H, BWP202424H, BWP202429H, BWP202183H, BWP202279H, BWP202362H, BWP202363H, BWP202364H, BWP202496H, BWP202291H, BWP202189H, BWP202338H, BWP202273H, BWP202488H, BWP202573H, BWP202508H, BWP202587H, BWP202349H, BWP202466H, BWP202354H, BWP202376H, BWP202455H, BWP202612H, BWP201861H, BWP202188H, BWP202284H, BWP202309H, BWP202168H, BWP202334H, BWP202381H, BWP202303H, BWP202223H, BWP202409H, BWP202249H, BWP202173H, BWP202158H, BWP202635H, BWP202415H, BWP202438H, BWP202177H, BWP202315H, BWP202360H, BWP202372H, BWP202388H, BWP202451H, BWP202498H, BWP202500H, BWP202504H, BWP202507H, BWP202515H, BWP202525H, BWP202531H, BWP202584H, BWP202589H, BWP202290H, BWP202237H, BWP202330H, BWP201862H, BWP202199H, BWP202256H, BWP202396H, BWP202378H, BWP202368H, BWP202356H, BWP202459H, BWP202167H, BWP202380H, BWP202230H, BWP202400H, BWP202236H, BWP202335H, BWP202351H, BWP202539H, BWP202574H, BWP202575H, BWP202596H, BWP202633H, BWP202476H, BWP202478H, BWP202479H, BWP202480H, BWP202481H, BWP202482H, BWP202343H, BWP202206H, BWP202251H, BWP202345H, BWP202352H, BWP202386H, BWP202205H, BWP202433H, BWP202340H, BWP202556H, BWP202286H, BWP202234H, BWP202169H, BWP202259H, BWP202263H, BWP202214H, BWP202216H, BWP202220H, BWP202248H, BWP202310H, BWP202552H, BWP202597H, BWP202410H, BWP202240H, BWP202243H, BWP202328H, BWP202464H, BWP202568H, BWP202170H, BWP202411H, BWP202276H, BWP202221H, BWP202178H, BWP202538H, BWP202551H, BWP202174H, BWP202289H, BWP202483H, BWP202485H, BWP202486H, BWP202608H, BWP202232H, BWP202241H, BWP202245H, BWP202253H, BWP202264H, BWP202313H, BWP202323H, BWP202336H, BWP202339H, BWP202341H, BWP202346H, BWP202370H, BWP202383H, BWP202389H, BWP202393H, BWP202395H, BWP202423H, BWP202436H, BWP202441H, BWP202442H, BWP202445H, BWP202448H, BWP202463H, BWP202487H, BWP202492H, BWP202501H, BWP202509H, BWP202511H, BWP202512H, BWP202513H, BWP202517H, BWP202518H, BWP202533H, BWP202555H, BWP202572H, BWP202581H, BWP202590H, BWP202244H, BWP202427H, BWP202428H, BWP202591H, BWP202599H, BWP202624H, BWP202305H, BWP202565H, BWP202625H",
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}