{
  "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": "136964",
      "product_res_number": "Z-1751-2015",
      "event_date_initiated": "2015-04-29",
      "event_date_posted": "2015-06-10",
      "recall_status": "Open, Classified",
      "res_event_number": "71241",
      "product_code": "DSQ",
      "pma_numbers": [
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      ],
      "product_description": "HeartWare Ventricular Assist System (HVAD) For 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-Hour Clinical Support\n888-494-6365",
      "reason_for_recall": "Complaints with the HVAD Discolored and Cracked Driveline Outer Sheath.",
      "root_cause_description": "Device Design",
      "product_quantity": "3,747 currently in use",
      "distribution_pattern": "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, and VA, \nForeign: 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,\nMalaysia, Netherlands, New Zealand, Norway, Poland, Romania, Singapore, \nSlovakia, 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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          "P170038",
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          "P160054",
          "P900023",
          "P920014",
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