{
  "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": {
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      "cfres_id": "204271",
      "product_res_number": "Z-0480-2024",
      "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": "1104CA-CLIN - HVAD (HeartWare Ventricular Assist Device) PUMP, Model Number 1104CA-CLIN",
      "code_info": "Serial numbers:  HW24101, HW24102, HW24103, HW24104, HW24763, HW24755FSCA",
      "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": "6 units",
      "distribution_pattern": "Worldwide",
      "openfda": {
        "device_name": "Ventricular (Assist) Bypass",
        "medical_specialty_description": "Unknown",
        "regulation_number": "",
        "device_class": "3",
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