{
  "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": "2026-08-13",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "49143",
      "product_res_number": "Z-0341-2007",
      "event_date_initiated": "2006-10-17",
      "event_date_posted": "2007-01-25",
      "recall_status": "Terminated",
      "event_date_terminated": "2009-10-02",
      "res_event_number": "36672",
      "product_code": "LYJ",
      "pma_numbers": [
        "P970003"
      ],
      "product_description": "Cyberonics VNS Therapy System, Model 250-''HAND HELD'' programming software v6.1, v6.1.7, v7.0 and v7.1.3; manufactured by Cyberonics, Inc., Houston, TX.",
      "code_info": "For Software v6.1: 10-005-9400 and 10-006-0900; For Software v6.1.7: 10-0007-2400 and 10-0007-2500; For Software v7.0: 10-0007-4100 and 10-0007-2500; For Software v7.1.3: 10-0007-8400 and 10-0007-8500;",
      "firm_fei_number": "1000117004",
      "recalling_firm": "Cyberonics, Inc",
      "address_1": "100 Cyberonics Blvd",
      "city": "Houston",
      "state": "TX",
      "postal_code": "77058-2069",
      "reason_for_recall": "During programming, pulse generator may be inadvertently set to 8.0 mA  output, regardless of the mA range selected by the clinician",
      "root_cause_description": "Other",
      "action": "Firm sent safety alert to physicians on 11/14/06.  Safety Alert informs physicians of the problem and provides instructions on how to avoid an event and correct an event should it occur.",
      "product_quantity": "3,538 Flashcards containing software.",
      "distribution_pattern": "Worldwide Distribution ---- USA and countries of Argentina, Australia, Austria, Belgium, Canada, Cyprus, Czech Rep, Denmark, Finland, France, Germany, Greece, Hong Kong, Hungary, Iceland, Ireland, Israel, Italy, Japan, Jordan, Malaysia, Mexico, Netherlands, Norway, Poland, Portugal, S. Korea, Slovenia, South Africa, Spain, Sweden, Switzerland, Turkey, United Kingdom, and Venezuela.",
      "openfda": {
        "pma_number": [
          "P970003"
        ],
        "device_name": "Stimulator, Autonomic Nerve, Implanted For Epilepsy",
        "medical_specialty_description": "Unknown",
        "regulation_number": "",
        "device_class": "3",
        "registration_number": [
          "1644487"
        ],
        "fei_number": [
          "1000117004"
        ]
      }
    }
  ]
}