{
  "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": [
    {
      "country": "United States",
      "city": "Pleasanton",
      "address_1": "6035 Stoneridge Dr",
      "reason_for_recall": "St. Jude Medical is providing all users of their HeartMate II LVAS with Pocket Controller with new software and updates to hardware to make the exchange to a backup controller easier. This is related to recall Z-1227/1230-2014.",
      "address_2": "",
      "product_quantity": "24,077 active units in US",
      "code_info": "Serial numbers PC-14810, PC-14828, PC-14843, PC-14846, and PC-14848.",
      "center_classification_date": "20170524",
      "distribution_pattern": "Worldwide Distribution -- US and Austria, Belgium, Brazil, Canada, Cayman Islands, Chile, Columbia, Croatia, Czech Republic, Denmark, Egypt, Estonia, France, Germany, Greece, Hong Kong, Hungary, India, Iran, Ireland, Israel, Italy, Kazakhstan, Kuwait, Latvia, Lebanon, Liechtenstein, Lithuania, Malaysia, Orman, Palastine, Poland, Qatar, Russian Federation, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, Spain, Sweden, Switzerland, Thailand, The Netherlands, Turkey, United Arab Emirates, and United Kingdom.",
      "state": "CA",
      "product_description": "HeartMate¿ II LVAS with Pocket Controller;  106015 - \tHMII LVAD SEALED KIT-PCTRL, NA  UDI: 00813024011224    Intended to provide hemodynamic support in patients with end-stage, refractory left ventricular heart failure; intended for use inside or outside the hospital.",
      "report_date": "20170531",
      "classification": "Class I",
      "openfda": {},
      "recalling_firm": "Thoratec Corporation",
      "recall_number": "Z-2052-2017",
      "initial_firm_notification": "Letter",
      "product_type": "Devices",
      "event_id": "76978",
      "termination_date": "20190320",
      "more_code_info": "",
      "recall_initiation_date": "20170330",
      "postal_code": "94588-3270",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "status": "Terminated"
    }
  ]
}