{
  "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": "86570",
      "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": "Letter",
      "distribution_pattern": "U.S.: AK, AL, AZ, CA, CO, DC, FL, HI, ID, IL, IN, KS, KY, LA, ME, MI, MN, MO, MT, NC, NE, NV, OK, OR, PR, TX, UT, VA, and WA     O.U.S.: Argentina, Finland and Peru",
      "recall_number": "Z-0462-2021",
      "product_description": "VNS Therapy¿ AspireSR¿ Generator",
      "product_quantity": "134 generators",
      "reason_for_recall": "Due to an extra digit being inadvertently added to the serial number of a subset of implantable pulse generators, they become not compatible with therapy programmers with software version 11.0.4.",
      "recall_initiation_date": "20200928",
      "center_classification_date": "20201117",
      "termination_date": "20221102",
      "report_date": "20201125",
      "code_info": "Model Number: 106    Serial   Number   UDI  1267031 010542502575006111191206172111182112670319910-0011-2101  1267050 010542502575006111191206172111182112670509910-0011-2101  1267039 010542502575006111191206172111182112670399910-0011-2101  1267030 010542502575006111191206172111182112670309910-0011-2101  1267025 010542502575006111191206172111182112670259910-0011-2101  1267028 010542502575006111191206172111182112670289910-0011-2101  1267047 010542502575006111191206172111182112670479910-0011-2101  1267020 010542502575006111191206172111182112670209910-0011-2101  1267003 010542502575006111191206172111182112670039910-0011-2101  1267049 010542502575006111191206172111182112670499910-0011-2101  1267037 010542502575006111191206172111182112670379910-0011-2101  1267033 010542502575006111191206172111182112670339910-0011-2101  1267027 010542502575006111191206172111182112670279910-0011-2101  1267001 010542502575006111191206172111182112670019910-0011-2101  1267054 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}