{
  "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": "2026-04-15",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Terminated",
      "city": "Miami Lakes",
      "state": "FL",
      "country": "United States",
      "classification": "Class I",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "70340",
      "recalling_firm": "HeartWare Inc",
      "address_1": "14400 Nw 60th Ave",
      "address_2": "N/A",
      "postal_code": "33014-2807",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit",
      "distribution_pattern": "Worldwide Distribution - US Nationwide in the states of:  AL, AZ, CA, CO, FL, GA, IL, IN, KY, LA, MA, MD, MI, MN, MO, NC, NY, OH, OR, PA, TX, UT, VA, WA and District of Columbia and countries of:  Canada, Poland, Australia, Austria, Italy, DE, New Zealand, South Africa, France, Switzerland, Germany, Brazil, UK, Belgium, Netherlands, Israel, Malaysia, Turkey, Greece, Japan, Singapore, Poland, Lithuania, Sweden, Norway, Finland, and India.",
      "recall_number": "Z-1131-2015",
      "product_description": "HeartWare Ventricular Assist System (HeartWare Controller)    Product Usage:  For use as a bridge-to-cardiac transplantation in patients who are at risk of death from refractory end-stage left ventricular heart failure. The HeartWare System is designed for in-hospital and out-of-hospital settings, including transportation via fix-wing aircraft or helicopter.",
      "product_quantity": "4,845",
      "reason_for_recall": "The affected clinical trial Controllers exhibit a higher susceptibility to ESD than newer commercial Controllers.",
      "recall_initiation_date": "20150116",
      "center_classification_date": "20150225",
      "termination_date": "20200205",
      "report_date": "20150304",
      "code_info": "Product Codes- US product: Model No.: 1400, 1401US; International product: Model No.: 1400, 1401XX ('XX' represents country designation)  Serial No.: CON000001 through CON005472",
      "more_code_info": ""
    }
  ]
}