{
  "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": "2026-09-03",
    "results": {
      "skip": 0,
      "limit": 1,
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  },
  "results": [
    {
      "cfres_id": "136957",
      "product_res_number": "Z-1917-2015",
      "event_date_initiated": "2015-04-29",
      "event_date_posted": "2015-06-26",
      "recall_status": "Open, Classified",
      "res_event_number": "71240",
      "product_code": "DSQ",
      "pma_numbers": [
        "P100047"
      ],
      "product_description": "HeartWare Ventricular Assist System (HVAD)\nFor use as a bridge-to-cardiac transplantation in patient who are at risk of death from refractory end-stage left ventricular heart failure.",
      "code_info": "Catalog #'s US: 1101 and 1103 / OUS: 1100,1101,1102,1104,1104JP and 1205. Serial #: ALL HeartWare HVAD systems currently in use.",
      "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": "24-Hours Clinical Support\n888-494-6365",
      "reason_for_recall": "Complaints with the HVAD Abnormal Power Source Switching.",
      "root_cause_description": "Software design",
      "action": "HeartWare sent an Urgent Medical Device Correction letter to all affected customers.   The letter identified the product, the problem, and the action to be taken by the customer.  Customers were instructed to review the enclosed Patient Communication and familiarize the contents, forward the notice to those individuals withing their organization who need to be aware of its contents, identify their patients currently supported by the HVAD System, distribute the Patient Communication to their patients via FedEX or some other reliable means of communication.  Customers with questions were instructed to contact their HeartWare representative should they need any assistance with the process.  Customers were asked to complete, sign, and return the Acknowledgement and Completion Form to HeartWare.   Customers with quesitons were instructed to call 1-888-494-6365.",
      "product_quantity": "3,747 currently in use.",
      "distribution_pattern": "US including AL, AZ, CA, CO, CT, DC, DE, FL, GA, IA, IL, IN, KY, LA, MA, MD, MI, MN, MO, MS, NC, NH, NJ, NY, OH, OR, PA, SC, TN, TX, UT, VA and Internationally to Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, Croatia, Czech Republic, Denmark, Egypt, Finland, France, Germany, Greece, Hong Kong, Hungary, India, Israel, Italy, Japan, Korea, Lebanon, Lithuania, Luxemburg, Malaysia, Netherlands, New Zealand, Norway, Poland, Romania, Singapore, Slovakia, South Africa, Spain, Sweden, Switzerland, Turkey, and UK.",
      "openfda": {
        "device_name": "Ventricular (Assist) Bypass",
        "medical_specialty_description": "Unknown",
        "regulation_number": "",
        "device_class": "3",
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          "P060040",
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