{
  "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-2348-2019",
      "product_description": "Thoratec HeartMate 3 LVAS Implant Kit, Sterile, REF 106524/106524US, RX only, Left Ventricular Assist System",
      "product_quantity": "7200 left ventricular assist systems",
      "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": "106524/106524US: The shelf life is 36 months from date of manufacture.  All batch/lot numbers 6613000 or 50000000 or higher.      UDI/GMDN 00813024013297 / 47533"
    }
  ]
}