{
  "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,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "136951",
      "product_res_number": "Z-1731-2015",
      "event_date_initiated": "2015-04-29",
      "event_date_posted": "2015-06-13",
      "recall_status": "Open, Classified",
      "res_event_number": "71239",
      "product_code": "DSQ",
      "pma_numbers": [
        "P100047"
      ],
      "product_description": "HeartWare Ventricular Assist System (HVAD).  \nCatalog #'s US: 1101 and 1103 / OUS: 1100,1101,1102,1104,1104JP and 1205.\n\nFor use as a bridge-to-cardiac transplantation in patients who are at risk of death from refractory end-stage left ventricular heart failure.",
      "code_info": "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 Internal Controller Alarm Battery failures.",
      "root_cause_description": "Device Design",
      "action": "Urgent Medical Device Correction letters were sent to customers.  The letter identified the affected product, as well as the reason for the recall and risks involved.  HeartWare requests that customers review and familiarize themselves with the letter and \"Patient Communication,\" and ensure that all necessary individuals are aware.  Patients currently being supported by the device should be identified and given the \"Patient Communication.\"  A HeartWare representative can provide assistance with that process if needed.  The \"Acknowledgement and Completion Form\" should be completed, signed, and returned within 30 days of the receipt of the letter.  Customers can contact their local HeartWare representative with questions or concerns.  Clinical Support personnel are also available at 1-888-494-6365.",
      "product_quantity": "3,747 curently implanted",
      "distribution_pattern": "Worldwide Distribution -- US, including the states of 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; and, the countries of 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, Luxembourg, 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",
        "pma_number": [
          "P100047",
          "P170038",
          "P060040",
          "P160054",
          "P900023",
          "P920014",
          "P980012",
          "P160035",
          "P870072"
        ],
        "registration_number": [
          "2029275",
          "3019807891",
          "2916596",
          "3011823740",
          "2134470",
          "3007042319",
          "3005228872",
          "9612515",
          "3012931014",
          "2031044",
          "2133810",
          "2182208",
          "3008454189",
          "2528981",
          "1927395",
          "3002807090",
          "1721676",
          "1218444",
          "3010163695",
          "1319639",
          "3003306248",
          "3004582654",
          "3008792657"
        ],
        "fei_number": [
          "3019807891",
          "2916596",
          "3011823740",
          "3007042319",
          "3000203066",
          "3005228872",
          "3012931014",
          "1000138054",
          "3002808437",
          "3002462840",
          "2182208",
          "3008454189",
          "1000306431",
          "2528981",
          "1927395",
          "1721676",
          "1218444",
          "3010163695",
          "3001236763",
          "3003306248",
          "3006003617",
          "3004582654",
          "3008792657"
        ]
      }
    }
  ]
}