{
  "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": "2026-04-22",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Terminated",
      "city": "Pleasanton",
      "state": "CA",
      "country": "United States",
      "classification": "Class I",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "67639",
      "recalling_firm": "Thoratec Corporation",
      "address_1": "6035 Stoneridge Dr",
      "address_2": "N/A",
      "postal_code": "94588-3270",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Press Release",
      "distribution_pattern": "Worldwide distribution: US (nationwide) including states of: AL, AR, AZ, CA, CO, CT, 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: Austria, Belgium, Czech Republic, France, Germany, Ireland, Israel, Italy, Lebanon, Lithuania, Poland, Saudi Arabia, Singapore, Slovenia, Sweden, Switzerland, The Netherlands, Turkey, and United Kingdom.",
      "recall_number": "Z-1228-2014",
      "product_description": "HeartMate II System Controller    Product Usage:  HeartMate II is a mechanical device that circulates blood throughout the body when the heart is too weak to pump blood adequately on its own. It is sometimes called a a heart pump or VAD. HeartMate II is a small implantable LVAD. HeartMate II attaches to the heart and is designed to assist or take over the pumping function of the patients left ventricle, the main pumping chamber of the heart.",
      "product_quantity": "4120",
      "reason_for_recall": "Discovery of serious injuries and deaths associated with the process of changing from a primary System controller to their back-up System controller in patients using the Pocket System controller model.",
      "recall_initiation_date": "20140304",
      "center_classification_date": "20140321",
      "termination_date": "20150827",
      "report_date": "20140402",
      "code_info": "Catalog number 106762 (NAm)  106017 - EU  all serial numbers"
    }
  ]
}