{
  "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": "2026-04-01",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Terminated",
      "city": "Pleasanton",
      "state": "CA",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "83357",
      "recalling_firm": "Thoratec Corp.",
      "address_1": "6035 Stoneridge Dr",
      "address_2": "N/A",
      "postal_code": "94588-3270",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "N/A",
      "distribution_pattern": "Worldwide distribution.  US nationwide, Australia, Austria, Brazil, Canada, Cayman Islands, Chile, Colombia, Egypt, France, Germany, Greece, Singapore, Iran, Italy, Kuwait, Lebanon, Romania, Switzerland, Thailand, United Kingdom.",
      "recall_number": "Z-2349-2019",
      "product_description": "Thoratec Heartmate 3 Sealed Outflow Graft with Bend Relief, Sterile, REF 105581US/105581, RX only, Part of Left Ventricular Assist Device (LVAD)    UDI: 00813024013266",
      "product_quantity": "149 outflow graft units",
      "reason_for_recall": "Outflow Graft leaking at the pump connection during the implantation process. If the C-Ring is insufficiently seated, it renders the device nonfunctional because the Outflow Graft connection will leak during the implant procedure.",
      "recall_initiation_date": "20190330",
      "center_classification_date": "20190822",
      "termination_date": "20200824",
      "report_date": "20190828",
      "code_info": "105581/105581US: The shelf life is 60 months from date of manufacture.  All batch/lot numbers 6613000 and below or 50000000 and higher.    UDI/GMDN 00813024013266 / 61747"
    }
  ]
}