{
  "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": "2026-08-13",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "146078",
      "product_res_number": "Z-0005-2017",
      "event_date_initiated": "2016-06-08",
      "event_date_posted": "2016-10-17",
      "recall_status": "Terminated",
      "event_date_terminated": "2020-03-31",
      "res_event_number": "72001",
      "product_code": "DSQ",
      "pma_numbers": [
        "P100047"
      ],
      "product_description": "HeartWare Ventricular Assist System Controller \n\nProduct Usage:\nFor use as a bridge-to-cardiac transplantation in patients who are at risk of death from refractory end-stage left ventricular heart failure. The HVAD is designed for in-hospital and out-of-hospital settings, including transportation via fix-wing aircraft or helicopter",
      "code_info": "All Heartware Controllers manufactured after September 2014. US Model No: 1400, 1401XX, 1403US.  International Model No: 1400, 1401XX, 1407XX.",
      "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": "Customer Service\n305-364-1575",
      "reason_for_recall": "Loose connector ports in controller body.",
      "root_cause_description": "Device Design",
      "action": "HeartWare sent an Urgent Medical Device Correction letter dated June 8, 2016, to all affected customers, HeartWare advised clinicians to remind patients to follow unit instructions and water avoidance, and to regularly schedule appointments to check the integrity of the unit and to be cautious with connectors when inspecting connectors. Clinicians were also instructed to send back the enclosed \"Acknowledgement Form\" within 30 days and to forward the message to necessary individuals within their organization.\nCustomers with questions were instructed to contact their local HeartWare representative.\nFor questions regarding this recall call 305-364-1575.",
      "product_quantity": "4235  Worldwide, 7272 units in U.S.",
      "distribution_pattern": "Worldwide Distribution - US Nationwide in the states of AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, IA, IL, IN, KY, LA, MA, MD, MI, MN, MO, MS, NC, NE, NJ, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, and WI and countries of Australia, Austria, Belgium, Canada, France, Germany, Lebanon, Malaysia, Sweden, Switzerland, & United Kingdom.",
      "openfda": {
        "device_name": "Ventricular (Assist) Bypass",
        "medical_specialty_description": "Unknown",
        "regulation_number": "",
        "device_class": "3",
        "pma_number": [
          "P170038",
          "P920014",
          "P870072",
          "P160035",
          "P900023",
          "P100047",
          "P160054",
          "P980012",
          "P060040"
        ],
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          "9612515",
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        "fei_number": [
          "3001236763",
          "1000138054",
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}