{
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  "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-0476-2024.jsonld",
  "@type": "schema:Dataset",
  "name": "STERILE HVAD (HeartWare Ventricular Assist Device) PUMP (US), Model Number 1101",
  "description": "FDA recall Z-0476-2024 — Heartware, Inc. is recalling STERILE HVAD (HeartWare Ventricular Assist Device) PUMP (US), Model Number 1101 (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.",
  "license": "https://creativecommons.org/publicdomain/zero/1.0/",
  "isAccessibleForFree": true,
  "isPartOf": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/",
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  "seeAlso": "https://agenticu.ryanjhunter.workers.dev/commons/the-research-object",
  "dateModified": "2026-06-24T07:02:03.626072+00:00",
  "isBasedOn": {
    "@type": "schema:Dataset",
    "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-0476-2024&lang=eng",
  "about": {
    "@type": "schema:MedicalDevice",
    "name": "STERILE HVAD (HeartWare Ventricular Assist Device) PUMP (US), Model Number 1101",
    "manufacturer": {
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      "name": "Heartware, Inc."
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    {
      "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-0476-2024/enforcement-record",
      "@type": "schema:Claim",
      "name": "FDA recall Z-0476-2024: Heartware, Inc. is recalling STERILE HVAD (HeartWare Ventricular Assist Device) PUMP (US), Model Number 1101",
      "text": "The FDA logged enforcement record Z-0476-2024: Heartware, Inc. is voluntarily recalling STERILE HVAD (HeartWare Ventricular Assist Device) PUMP (US), Model Number 1101 — 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: Serial numbers:  hw1005, HW1015, HW1020, HW1021, HW1022, HW1023, HW1025, HW1028, HW1031, HW1033, HW107, HW1088, HW1089, HW1090, HW1091, HW1092, HW1138, HW1139, HW1142, HW1143, HW1144, HW1146, HW1148, HW1171, HW1183, HW1200, HW1201, HW1202, HW1203, HW1204, HW1205, HW1209, HW1211, HW1222, HW1240, HW1241, HW1242, HW1243, HW1244, HW1245, HW1246, HW1247, HW1248, HW1249, HW1250, HW1252, HW1254, HW1257, HW1258, HW1261, HW1262, HW1263, HW1264, HW1265, HW1267, hw1273, HW1276, HW1277, HW1278, HW1280, HW1283, HW1292, HW1297, HW1305, HW1306, HW1308, HW1310, HW1311, HW134, HW1397, HW1398, HW1403, HW1404, HW1415, HW1426, HW1428, HW1430, HW1434, HW1437, HW1439, HW1441, HW1452, HW1454, HW1456, HW1457, HW1461, HW1462, HW1465, HW1466, HW1488, HW1510, HW1512, HW1517, HW1524, HW1528, HW1532, HW1533, HW1534, HW1535, HW1543, HW1553, HW1555, HW1556, HW1562, HW1573, HW1574, HW1589, HW1598, HW1608, HW1612, HW1618, HW1622, HW1627, HW1629, HW1630, HW1632, HW1633, HW1634, HW1636, HW1637, HW166, HW167, HW1688, HW1689, HW1694, HW1697, HW1728, HW1729, HW1733, HW174, HW1745, HW1748, HW1750, HW1757, HW176, HW1769, HW1771, HW1772, HW1801, HW1813, HW1816, HW1817, HW1818, HW182, HW184, HW187, HW190, HW191, HW1951, HW1955, HW196, HW1963, HW198, HW199, HW200, HW201, HW202, HW204, HW207, hw209, HW210, HW211, HW212, HW213, HW214, HW216, HW217, HW220, HW221, HW224, HW226, HW227, HW229, HW230, HW233, HW236, HW239, HW240, HW247, HW249, HW250, HW251, HW253, HW254, HW255, HW256, HW257, HW258, HW260, HW261, HW262, HW263, HW277, HW278, HW279, HW281, HW282, HW284, HW286, HW290, HW292, HW296, HW297, HW298, HW299, HW303, HW304, HW305, HW310, HW313, HW314, HW317, HW319, HW321, HW323, HW324, HW328, HW330, HW335, HW336, HW337, HW338, HW339, HW344, HW346, HW347, HW348, HW363, HW378, HW379, HW380, HW381, HW382, HW383, HW384, HW405, HW406, HW415, HW425, HW430, HW431, HW433, HW440, HW441, HW442, HW444, HW446, HW447, HW454, HW456, HW466, HW467, HW468, HW469, HW474, HW475, HW479, HW481, HW482, HW484, HW486, HW488, HW490, HW492, HW494, HW497, HW498, HW500, HW505, HW506, HW525, HW526, HW527, HW528, HW529, HW530, HW531, HW534, HW535, HW536, HW555, HW556, HW557, HW560, HW561, HW562, HW563, HW564, HW567, HW568, hw575, HW577, HW578, HW581, HW583, HW584, HW585, HW590, HW591, HW600, HW602, HW603, HW608, hw609, HW610, HW622, HW623, HW626, HW628, HW633, HW635, HW636, HW640, HW643, HW644, HW645, HW646, HW650, HW658, HW659, HW660, HW661, HW678, HW691, HW692, HW693, HW694, HW739, HW741, HW748, HW749, HW764, HW768, HW770, HW785, HW795, HW796, HW798, HW801, HW815, HW816, HW817, HW819, HW820, HW821, HW822, HW823, HW824, HW825, HW826, HW827, HW857, HW858, HW861, HW863, HW865, HW867, HW877, HW885, HW886, HW887, HW888, HW889, HW891, HW901, HW917, HW919, HW920, HW921, HW922, HW923, HW928, HW932, HW933, HW936, HW943, HW947, HW978, HW979, HW980. A RECORDED FDA enforcement action (occurred=true).",
      "claimType": "official_fact",
      "reviewStatus": "current",
      "commercialInfluence": false,
      "epistemicStatus": {
        "occurred": true,
        "supported": true,
        "adjudged": true,
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      "grounding": {
        "groundingType": "SourceCitation",
        "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-0476-2024&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-0476-2024&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."
    },
    {
      "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-0476-2024/fda-classification",
      "@type": "schema:Claim",
      "name": "FDA classified recall Z-0476-2024 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",
      "commercialInfluence": false,
      "epistemicStatus": {
        "occurred": false,
        "supported": true,
        "adjudged": true,
        "operative": true
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      "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-0476-2024&lang=eng",
        "value": "Class II",
        "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-0476-2024&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-0476-2024/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
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      "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-0476-2024",
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            "Value": "Z-0476-2024",
            "Status": "recorded"
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            "Value": "Ongoing — the recall is still being carried out.",
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          "item": {
            "Field": "Recalling firm",
            "Value": "Heartware, Inc.",
            "Status": "recorded"
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            "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",
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          "item": {
            "Field": "Initiated",
            "Value": "2023-10-31",
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            "Value": "Serial numbers:  hw1005, HW1015, HW1020, HW1021, HW1022, HW1023, HW1025, HW1028, HW1031, HW1033, HW107, HW1088, HW1089, HW1090, HW1091, HW1092, HW1138, HW1139, HW1142, HW1143, HW1144, HW1146, HW1148, HW1171, HW1183, HW1200, HW1201, HW1202, HW1203, HW1204, HW1205, HW1209, HW1211, HW1222, HW1240, HW1241, HW1242, HW1243, HW1244, HW1245, HW1246, HW1247, HW1248, HW1249, HW1250, HW1252, HW1254, HW1257, HW1258, HW1261, HW1262, HW1263, HW1264, HW1265, HW1267, hw1273, HW1276, HW1277, HW1278, HW1280, HW1283, HW1292, HW1297, HW1305, HW1306, HW1308, HW1310, HW1311, HW134, HW1397, HW1398, HW1403, HW1404, HW1415, HW1426, HW1428, HW1430, HW1434, HW1437, HW1439, HW1441, HW1452, HW1454, HW1456, HW1457, HW1461, HW1462, HW1465, HW1466, HW1488, HW1510, HW1512, HW1517, HW1524, HW1528, HW1532, HW1533, HW1534, HW1535, HW1543, HW1553, HW1555, HW1556, HW1562, HW1573, HW1574, HW1589, HW1598, HW1608, HW1612, HW1618, HW1622, HW1627, HW1629, HW1630, HW1632, HW1633, HW1634, HW1636, HW1637, HW166, HW167, HW1688, HW1689, HW1694, HW1697, HW1728, HW1729, HW1733, HW174, HW1745, HW1748, HW1750, HW1757, HW176, HW1769, HW1771, HW1772, HW1801, HW1813, HW1816, HW1817, HW1818, HW182, HW184, HW187, HW190, HW191, HW1951, HW1955, HW196, HW1963, HW198, HW199, HW200, HW201, HW202, HW204, HW207, hw209, HW210, HW211, HW212, HW213, HW214, HW216, HW217, HW220, HW221, HW224, HW226, HW227, HW229, HW230, HW233, HW236, HW239, HW240, HW247, HW249, HW250, HW251, HW253, HW254, HW255, HW256, HW257, HW258, HW260, HW261, HW262, HW263, HW277, HW278, HW279, HW281, HW282, HW284, HW286, HW290, HW292, HW296, HW297, HW298, HW299, HW303, HW304, HW305, HW310, HW313, HW314, HW317, HW319, HW321, HW323, HW324, HW328, HW330, HW335, HW336, HW337, HW338, HW339, HW344, HW346, HW347, HW348, HW363, HW378, HW379, HW380, HW381, HW382, HW383, HW384, HW405, HW406, HW415, HW425, HW430, HW431, HW433, HW440, HW441, HW442, HW444, HW446, HW447, HW454, HW456, HW466, HW467, HW468, HW469, HW474, HW475, HW479, HW481, HW482, HW484, HW486, HW488, HW490, HW492, HW494, HW497, HW498, HW500, HW505, HW506, HW525, HW526, HW527, HW528, HW529, HW530, HW531, HW534, HW535, HW536, HW555, HW556, HW557, HW560, HW561, HW562, HW563, HW564, HW567, HW568, hw575, HW577, HW578, HW581, HW583, HW584, HW585, HW590, HW591, HW600, HW602, HW603, HW608, hw609, HW610, HW622, HW623, HW626, HW628, HW633, HW635, HW636, HW640, HW643, HW644, HW645, HW646, HW650, HW658, HW659, HW660, HW661, HW678, HW691, HW692, HW693, HW694, HW739, HW741, HW748, HW749, HW764, HW768, HW770, HW785, HW795, HW796, HW798, HW801, HW815, HW816, HW817, HW819, HW820, HW821, HW822, HW823, HW824, HW825, HW826, HW827, HW857, HW858, HW861, HW863, HW865, HW867, HW877, HW885, HW886, HW887, HW888, HW889, HW891, HW901, HW917, HW919, HW920, HW921, HW922, HW923, HW928, HW932, HW933, HW936, HW943, HW947, HW978, HW979, HW980",
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