{
  "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": "140876",
      "product_res_number": "Z-0280-2016",
      "event_date_initiated": "2015-10-07",
      "event_date_posted": "2015-11-17",
      "recall_status": "Terminated",
      "event_date_terminated": "2017-09-06",
      "res_event_number": "72385",
      "product_code": "LYJ",
      "pma_numbers": [
        "P970003"
      ],
      "product_description": "Cyberonics Vagus Nerve Stimulator (VNS) Therapy AspireSR Generator, Model 106",
      "code_info": "Serial Numbers: 37719, 37899, 38123, 38414, 38428, 39385, 39531, 39607, 39801, 39821, 40037, 40048, 40249, 40251, 40271, 40354, 40428, 40488, 40526, 40603, 40751, 41000, 41109, 41152, 41805, 42022, 42780",
      "firm_fei_number": "1000117004",
      "recalling_firm": "Cyberonics, Inc",
      "address_1": "100 Cyberonics Blvd",
      "city": "Houston",
      "state": "TX",
      "postal_code": "77058-2069",
      "additional_info_contact": "Clinical Technical Support\n866-882-8804",
      "reason_for_recall": "Certain Model 106 Pulse Generators demonstrate delays in sensing during use of the 'Verify Heartbeat Detection' feature and exhibit potential for decreased battery longevity.",
      "root_cause_description": "Manufacturing material removal",
      "action": "Cyberonics sent written recall notifications beginning October 14, 2015, to all affected customers. The letter identified the product the problem and the action to be taken by the customer. \n\nThe notice also directs customers to contact Cyberonics to schedule additional on-site troubleshooting.  The on-site troubleshooting proposed by Cyberonics will utilize a feature included within the Model 250 Version 9.0 Programming Software as an alternate method of verifying heart rate and determining that the appropriate heart beat sensitivity setting is programmed.  The Version 9.0 software displays an instantaneous heart rate when the user selects the 'Refresh' feature. This heart rate is measured directly by the generator and displayed on the programmer.\n\nFor further questions, please call (866) 882-8804.",
      "product_quantity": "27 units",
      "distribution_pattern": "US Distribution to the states of : OR, NY, GA, PA, CA, NC, KS, FL, KY, MI, TX, IL, OH, IN, UT, CO and WV.",
      "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"
        ]
      }
    }
  ]
}