{
  "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": "Houston",
      "state": "TX",
      "country": "United States",
      "classification": "Class I",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "83873",
      "recalling_firm": "LivaNova USA Inc",
      "address_1": "100 Cyberonics Blvd",
      "address_2": "",
      "postal_code": "77058-2069",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "U.S.: MN, IL, AK, NY, FL, PA, AR, CA, NC, WI, AZ, KY, TX, MA, MT, NE, IA, WV, CO, AL, MI, LA, VA, OH, MO, IN, NJ, GA, TN, MS, DC, SC, CT, UT, OK, MD, ID, KS, DE, OR, ND, WA, NM, PR.    OUS (foreign): AT, CH, DE, ES, FI, GB, IE, NL, NO, PT, SE, IT",
      "recall_number": "Z-0561-2020",
      "product_description": "VNS Therapy, SenTiva, Model # 1000, (01)05425025750405, Rx Only  for vagal nerve stimulation (VNS) therapy",
      "product_quantity": "1687",
      "reason_for_recall": "Sentiva generators may reset and become disabled within 60 days of enabling. Physicians can re-enable but devices will continue to be susceptible to resets. If a device experiences this issue, this may lead to additional surgery (premature replacement of generator), or patients may return to baseline seizure frequency or depressive symptoms due to cessation of intended stimulation.",
      "recall_initiation_date": "20190822",
      "center_classification_date": "20191220",
      "termination_date": "20240328",
      "report_date": "20200101",
      "code_info": "Implanted devices with Serial Numbers Greater Than or Equal to 100000 that did not undergo the internal error screen.",
      "more_code_info": ""
    }
  ]
}