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  "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-0483-2024.jsonld",
  "@type": "schema:Dataset",
  "name": "PUMP MCS1705PU HVAD (HeartWare Ventricular Assist Device) IMPLANT KIT US, Model Number MCS1705PU",
  "description": "FDA recall Z-0483-2024 — Heartware, Inc. is recalling PUMP MCS1705PU HVAD (HeartWare Ventricular Assist Device) IMPLANT KIT US, Model Number MCS1705PU (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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    "name": "openFDA drug & device enforcement (recall) reports",
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  "sameAs": "https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?action=select&recall_number=Z-0483-2024&lang=eng",
  "about": {
    "@type": "schema:MedicalDevice",
    "name": "PUMP MCS1705PU HVAD (HeartWare Ventricular Assist Device) IMPLANT KIT US, Model Number MCS1705PU",
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      "name": "Heartware, Inc."
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      "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-0483-2024/enforcement-record",
      "@type": "schema:Claim",
      "name": "FDA recall Z-0483-2024: Heartware, Inc. is recalling PUMP MCS1705PU HVAD (HeartWare Ventricular Assist Device) IMPLANT KIT US, Model Number MCS1705PU",
      "text": "The FDA logged enforcement record Z-0483-2024: Heartware, Inc. is voluntarily recalling PUMP MCS1705PU HVAD (HeartWare Ventricular Assist Device) IMPLANT KIT US, Model Number MCS1705PU — reason: Updates to the HVAD system instructions for use (IFU) and patient manual (PM) will be provided. These updates will clarify (1) the conditions under which an HVAD [Controller Fault] alarm may sound and the recommended troubleshooting actions and (2) instructions relating to the useful life of the HVAD system components. Status: Ongoing — the recall is still being carried out.. Initiated 2023-10-31. Affected lots/codes: GTIN 00888707005364, Serial Numbers:  HW43366, HW42611, HW43316, HW43247, HW43248, HW42405, HW43276, HW43251, HW43313, HW43322, HW43257, HW43262, HW43258, HW43270, HW43197, HW43157, HW43253, HW42375, HW42400, HW42582, HW43125, HW42083, HW43188, HW43042, HW42610, HW42301, HW43062, HW43219, HW43187, HW42420, HW43054, HW43115, HW43053, HW43116, HW42297, HW43109, HW42267, HW43048, HW42591, HW42439, HW42205, HW43040, HW42438, HW42586, HW42082, HW42585, HW42261, HW42404, HW42573, HW42364, HW42070, HW42202, HW42081, HW42184, HW42179, HW42069, HW42403, HW42176, HW41765;  GTIN 00888707005715, Serial Numbers:  HW42612, HW42685, HW42614, HW42681, HW42615, HW42618; GTIN 00888707007139, Serial Numbers:  HW42372, HW42691, HW42832, HW42713, HW43019, HW43027, HW43015, HW42847, HW42697, HW42963, HW42826, HW42929, HW42934, HW42975, HW42954, HW42845, HW42705, HW42846, HW42925, HW42977, HW42978, HW42839, HW42979, HW42980, HW42982, HW42984, HW42985, HW42986, HW42704, HW42930, HW42972, HW42853, HW42924, HW42935, HW42936, HW42956, HW42957, HW42958, HW42959, HW42945, HW42946, HW42950, HW42951, HW42706, HW42699, HW42701, HW42692, HW42693, HW42694, HW42695, HW42696;  GTIN 00888707007160, Serial Numbers:  HW43453;  GTIN 00888707009041, Serial Numbers:  HW43032, HW42484, HW42522, HW43489;  GTIN 00888707009423, Serial Numbers:  HW43068;  GTIN 00888707009454, Serial Numbers:  HW43096;  GTIN 00888707009485, Serial Numbers:  HW42688;  GTIN 00888707009492, Serial Numbers:  HW42926. A RECORDED FDA enforcement action (occurred=true).",
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      "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-0483-2024/fda-classification",
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      "name": "FDA classified recall Z-0483-2024 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.",
      "claimType": "regulatory_determination",
      "reviewStatus": "current",
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      "epistemicStatus": {
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        "adjudged": true,
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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."
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      "@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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        "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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      "name": "FDA recall details — Z-0483-2024",
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          "item": {
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            "Value": "Z-0483-2024",
            "Status": "recorded"
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          "item": {
            "Field": "Product type",
            "Value": "Devices",
            "Status": "recorded"
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          "position": 3,
          "item": {
            "Field": "Classification",
            "Value": "Class II",
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          "item": {
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            "Value": "Ongoing — the recall is still being carried out.",
            "Status": "recorded"
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          "position": 5,
          "item": {
            "Field": "Recalling firm",
            "Value": "Heartware, Inc.",
            "Status": "recorded"
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          "item": {
            "Field": "Reason",
            "Value": "Updates to the HVAD system instructions for use (IFU) and patient manual (PM) will be provided. These updates will clarify (1) the conditions under which an HVAD [Controller Fault] alarm may sound and the recommended troubleshooting actions and (2) instructions relating to the useful life of the HVAD system components",
            "Status": "recorded"
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          "item": {
            "Field": "Initiated",
            "Value": "2023-10-31",
            "Status": "recorded"
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          "position": 8,
          "item": {
            "Field": "Lot/code info",
            "Value": "GTIN 00888707005364, Serial Numbers:  HW43366, HW42611, HW43316, HW43247, HW43248, HW42405, HW43276, HW43251, HW43313, HW43322, HW43257, HW43262, HW43258, HW43270, HW43197, HW43157, HW43253, HW42375, HW42400, HW42582, HW43125, HW42083, HW43188, HW43042, HW42610, HW42301, HW43062, HW43219, HW43187, HW42420, HW43054, HW43115, HW43053, HW43116, HW42297, HW43109, HW42267, HW43048, HW42591, HW42439, HW42205, HW43040, HW42438, HW42586, HW42082, HW42585, HW42261, HW42404, HW42573, HW42364, HW42070, HW42202, HW42081, HW42184, HW42179, HW42069, HW42403, HW42176, HW41765;  GTIN 00888707005715, Serial Numbers:  HW42612, HW42685, HW42614, HW42681, HW42615, HW42618; GTIN 00888707007139, Serial Numbers:  HW42372, HW42691, HW42832, HW42713, HW43019, HW43027, HW43015, HW42847, HW42697, HW42963, HW42826, HW42929, HW42934, HW42975, HW42954, HW42845, HW42705, HW42846, HW42925, HW42977, HW42978, HW42839, HW42979, HW42980, HW42982, HW42984, HW42985, HW42986, HW42704, HW42930, HW42972, HW42853, HW42924, HW42935, HW42936, HW42956, HW42957, HW42958, HW42959, HW42945, HW42946, HW42950, HW42951, HW42706, HW42699, HW42701, HW42692, HW42693, HW42694, HW42695, HW42696;  GTIN 00888707007160, Serial Numbers:  HW43453;  GTIN 00888707009041, Serial Numbers:  HW43032, HW42484, HW42522, HW43489;  GTIN 00888707009423, Serial Numbers:  HW43068;  GTIN 00888707009454, Serial Numbers:  HW43096;  GTIN 00888707009485, Serial Numbers:  HW42688;  GTIN 00888707009492, Serial Numbers:  HW42926",
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            "Value": "Worldwide",
            "Status": "recorded"
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