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  "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-1462-2023.jsonld",
  "@type": "schema:Dataset",
  "name": "MAQUET CARDIOSAVE hybrid Intra-Aortic Balloon Pump, Model Number 0998-XX-0800-32",
  "description": "FDA recall Z-1462-2023 — Datascope Corp. is recalling MAQUET CARDIOSAVE hybrid Intra-Aortic Balloon Pump, Model Number 0998-XX-0800-32 (Devices, Class II). 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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      "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-1462-2023/enforcement-record",
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      "name": "FDA recall Z-1462-2023: Datascope Corp. is recalling MAQUET CARDIOSAVE hybrid Intra-Aortic Balloon Pump, Model Number 0998-XX-0800-32",
      "text": "The FDA logged enforcement record Z-1462-2023: Datascope Corp. is voluntarily recalling MAQUET CARDIOSAVE hybrid Intra-Aortic Balloon Pump, Model Number 0998-XX-0800-32 — reason: The power cord supplied (Type \u0018J\u0019 plug end) for the Cardiosave Hybrid IABP to Brazil is incompatible with the Brazilian Type \u0018N\u0019 power receptacle.. Status: Ongoing — the recall is still being carried out.. Initiated 2023-04-04. Affected lots/codes: UDI-DI: 10607567111117; Serial Numbers: CB343612K1 CB351306D2 CB360094J2 CB351302D2 CB343613K1 CB359782J2 CB359780J2 CB320625E0 CH207880C5 CB359783J2 CB328500J0 CB356765G2 CB356763G2 CB314092J9 CB355433F2 CB355432F2 CB351305D2 CB311676I9 CB355435F2 CB319727D0 CB319726D0 CB342653J1 CB307113G9 CB360092J2 CH245699K6 CB307117G9 CB360095J2 CB351303D2 CB320623E0 CB320621E0 CB320620E0 CB311677I9 CB314093J9 CB356761G2 CB351307D2 CB329943K0 CB360093J2 CB307111G9 CB343611K1 CB307114G9 CB320624E0 CB351301D2 CB359781J2 CB351304D2 CB356762G2 CB355434F2 CB322068F0 CB342652J1 CB311675I9 CB320622E0 CB355431F2 CB314094J9 CB307112G9 CB307119G9. A RECORDED FDA enforcement action (occurred=true).",
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        "adjudged": true,
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        "value": "Devices recall, status Ongoing",
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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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      "name": "FDA classified recall Z-1462-2023 as Class II",
      "text": "The FDA assigned this recall Class II: Class II — the FDA judged the product may cause temporary or medically reversible harm, with a remote chance of serious harm.. 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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        }
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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-1462-2023/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.",
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        "adjudicator": null
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      "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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            "Field": "Recalling firm",
            "Value": "Datascope Corp.",
            "Status": "recorded"
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          "position": 6,
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            "Field": "Reason",
            "Value": "The power cord supplied (Type \u0018J\u0019 plug end) for the Cardiosave Hybrid IABP to Brazil is incompatible with the Brazilian Type \u0018N\u0019 power receptacle.",
            "Status": "recorded"
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          "item": {
            "Field": "Initiated",
            "Value": "2023-04-04",
            "Status": "recorded"
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            "Field": "Lot/code info",
            "Value": "UDI-DI: 10607567111117; Serial Numbers: CB343612K1 CB351306D2 CB360094J2 CB351302D2 CB343613K1 CB359782J2 CB359780J2 CB320625E0 CH207880C5 CB359783J2 CB328500J0 CB356765G2 CB356763G2 CB314092J9 CB355433F2 CB355432F2 CB351305D2 CB311676I9 CB355435F2 CB319727D0 CB319726D0 CB342653J1 CB307113G9 CB360092J2 CH245699K6 CB307117G9 CB360095J2 CB351303D2 CB320623E0 CB320621E0 CB320620E0 CB311677I9 CB314093J9 CB356761G2 CB351307D2 CB329943K0 CB360093J2 CB307111G9 CB343611K1 CB307114G9 CB320624E0 CB351301D2 CB359781J2 CB351304D2 CB356762G2 CB355434F2 CB322068F0 CB342652J1 CB311675I9 CB320622E0 CB355431F2 CB314094J9 CB307112G9 CB307119G9",
            "Status": "recorded"
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          "item": {
            "Field": "Distribution pattern",
            "Value": "International distribution in the country of Brazil.",
            "Status": "recorded"
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