{
  "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 II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "89335",
      "recalling_firm": "LivaNova USA, Inc.",
      "address_1": "100 Cyberonics Blvd",
      "address_2": "N/A",
      "postal_code": "77058-2069",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit",
      "distribution_pattern": "US: NE, MO, AR, WV, KS, MA, IN",
      "recall_number": "Z-0532-2022",
      "product_description": "Vagus Nerve Stimulation (VNS) Therapy Leads, PerenniaDURA, Model: 303.   Model 303-20 PereniaDURA Lead (2.0 mm electrode inner diameter) and Model 303-30 PereniaDURA Lead (3.0 mm electrode inner diameter)",
      "product_quantity": "10",
      "reason_for_recall": "A manufacturing issue may cause the silicone tubing wall thickness of vagus nerve stimulation leads to be less than the design specification. If the tubing becomes completely breached, the patient may experience discomfort or pain due to delivery of stimulation to an unintended location. If the inner lead conductor is exposed to body fluids the lead may break causing loss of therapy.",
      "recall_initiation_date": "20211202",
      "center_classification_date": "20220128",
      "termination_date": "20240125",
      "report_date": "20220209",
      "code_info": "UDI: 05425025750115.   Serial Numbers: 119441, 119442, 119443, 119452, 119453, 119454, 119455, 119456, 119457, 119458"
    }
  ]
}