{
  "meta": {
    "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.",
    "terms": "https://open.fda.gov/terms/",
    "license": "https://open.fda.gov/license/",
    "last_updated": "2026-08-20",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "204274",
      "product_res_number": "Z-0483-2024",
      "event_date_initiated": "2023-10-31",
      "event_date_posted": "2023-12-02",
      "recall_status": "Open, Classified",
      "res_event_number": "93405",
      "product_code": "DSQ",
      "product_description": "PUMP MCS1705PU HVAD (HeartWare Ventricular Assist Device) IMPLANT KIT US, Model Number MCS1705PU",
      "code_info": "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; \nGTIN 00888707005715, Serial Numbers:  HW42612, HW42685, HW42614, HW42681, HW42615, HW42618;\nGTIN 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; \nGTIN 00888707007160, Serial Numbers:  HW43453; \nGTIN 00888707009041, Serial Numbers:  HW43032, HW42484, HW42522, HW43489; \nGTIN 00888707009423, Serial Numbers:  HW43068; \nGTIN 00888707009454, Serial Numbers:  HW43096; \nGTIN 00888707009485, Serial Numbers:  HW42688; \nGTIN 00888707009492, Serial Numbers:  HW42926",
      "firm_fei_number": "3007042319",
      "recalling_firm": "Heartware, Inc.",
      "address_1": "14400 Nw 60th Ave",
      "city": "Miami Lakes",
      "state": "FL",
      "postal_code": "33014-2807",
      "additional_info_contact": "MCS Customer Service\n877-367-4823",
      "reason_for_recall": "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",
      "root_cause_description": "Labeling design",
      "action": "Heartware issued an URGENT:  MEDICAL DEVICE CORRECTION notice to its consignees on 10/31/2023 via letter (UPS).  The notice explained the issue and informed them of the updates to the HVAD IFU and PM (patient manual).",
      "product_quantity": "125",
      "distribution_pattern": "Worldwide",
      "openfda": {
        "device_name": "Ventricular (Assist) Bypass",
        "medical_specialty_description": "Unknown",
        "regulation_number": "",
        "device_class": "3",
        "pma_number": [
          "P170038",
          "P100047",
          "P980012",
          "P160035",
          "P900023",
          "P060040",
          "P160054",
          "P920014",
          "P870072"
        ],
        "registration_number": [
          "3007042319",
          "1927395",
          "9612515",
          "3008792657",
          "3019807891",
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          "3008454189"
        ],
        "fei_number": [
          "3007042319",
          "1927395",
          "1000138054",
          "3000203066",
          "3008792657",
          "3001236763",
          "3019807891",
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      }
    }
  ]
}