{
  "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-1227-2014",
      "product_description": "HeartMate II Implant Kit with Pocket Controller;  with sealed grafts (NAm)  with sealed grafts (EU)    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.",
      "product_quantity": "1737 catalog number 106015; 609 catalog number 106016",
      "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 106015 (NAm)  106016 - EU  all serial numbers"
    }
  ]
}