{
  "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": "2026-08-20",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "84745",
      "product_res_number": "Z-0264-2010",
      "event_date_initiated": "2009-07-24",
      "event_date_posted": "2009-11-16",
      "recall_status": "Terminated",
      "event_date_terminated": "2012-09-26",
      "res_event_number": "53131",
      "product_code": "LYJ",
      "product_description": "Cyberonics VNS Therapy Programming M250 Programming System, model number 250, version 4.6, 6.1, 7.0 and 7.1.  The Model 250 Handheld software is provided on flashcards packaged in software envelopes or pre-installed on handheld computers.",
      "code_info": "Model 250, VNS Therapy Programming M250 Programming System, version 4.6, 6.1, 7.0 or 7.1 labeling",
      "firm_fei_number": "1000117004",
      "recalling_firm": "Cyberonics, Inc",
      "address_1": "100 Cyberonics Blvd",
      "city": "Houston",
      "state": "TX",
      "postal_code": "77058-2069",
      "additional_info_contact": "800-332-1375 Ext. 223",
      "reason_for_recall": "Some VNS Therapy System replacement Demipulse generators reporting low lead impedance readings.  In rare instances, a system diagnostic test using Model 250 Programming Software (versions 7.1 and earlier) may report \"Lead Impedance: OK\" when a short-circuit condition exists.",
      "root_cause_description": "Device Design",
      "action": "Cyberonics sent an Important Safety Notice on July 24, 2009, to all physicians explaining the event, risks presented and recommended actions to take.  \tLabeling updates are being developed concurrently with the notification.    The firm will mail or hand-deliver the notifications via firm representatives.",
      "product_quantity": "9,500 programming devices",
      "distribution_pattern": "Worldwide: USA, Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Chile, China, Colombia,  Costa Rica, Cyprus, Czech Republic, Denmark, Finland, France, Germany, Greece, Hong Kong, Hungary, Iceland, India, Iran, Ireland, Israel, Italy, Japan, Jordan, Kuwait, Lebanon, Luxembourg, Malaysia, Mexico, Morocco, Netherlands, Norway, Poland, Portugal, Puerto Rico (US Territory), Russia, San Marino, Saudi Arabia, Singapore, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Turkey, United Arab Emirates, 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"
        ]
      }
    }
  ]
}