{
  "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": "103797",
      "product_res_number": "Z-0210-2012",
      "event_date_initiated": "2011-08-12",
      "event_date_posted": "2011-11-18",
      "recall_status": "Terminated",
      "event_date_terminated": "2012-08-20",
      "res_event_number": "59818",
      "product_code": "LYJ",
      "pma_numbers": [
        "P970003"
      ],
      "product_description": "VNS Therapy Aspire HC Generator and VNS, Model 105\n\nCyberonics, Inc. 100 Cyberonics Blvd., Houston, TX 77058\n\nFor implantation in humans to treat Epilepsy and Depression.",
      "code_info": "Model 105, VNS Therapy AspireHC Generator",
      "firm_fei_number": "1000117004",
      "recalling_firm": "Cyberonics, Inc",
      "address_1": "100 Cyberonics Blvd",
      "city": "Houston",
      "state": "TX",
      "postal_code": "77058-2069",
      "additional_info_contact": "Brian Olin, Ph.D.\n281-228-7323 Ext. 223",
      "reason_for_recall": "The devices are being recalled because the output current delivered to the vagus nerve is less than the design intent and there is a potential charge imbalance at the lead cathode and generator-can during stimulation.",
      "root_cause_description": "Nonconforming Material/Component",
      "action": "Cyberonics sent a Field Safety Alert on August 15, 2011, to all affected customers.  The letter identified the product, the problem, and the action to be taken by the customer.   The firm decided to recall and initiated contact with implanting facilities in the United States on 08/15/2011.  A Field Safety Alert was delivered on 09/19/2011 to implanting facilities.  Customers were instructed not to prescribe AspireHC pulse generators for implant until Cyberonics resumes shipment of AspireHC pulse generators that have the issue remedied.  \nCyberonics recommends that physicians continue their current practice of titrating programming parameters for patients implanted with an AspireHC pulse generator to achieve appropriate clinical outcomes, paying particular attention to report of:\nLack or loss of efficacy\nPain, inflammation, swelling/edema in the neck area; and/or\nPatient perception of stimulation or muscle twitching in the area surrounding the implant.  \nCyberonics recommended routine systems diagnostic testing to aid in device and patient monitoring.  \nPhysicians may contact Clinical Technical Support at 866-882-8804 or via email at clinicaltechnicalservices@cyberonics.com.\nFor questions regarding this recall call 281-228-7323.",
      "product_quantity": "340 units",
      "distribution_pattern": "Worldwide Distribution - USA including TN, TX, IL, OH, FL, CA, CO, OR, AZ, NY, PA, MO, NJ, WI, OK, MI, ID, KY, IA, MA, NE, GA, LA, NY, and Norway.",
      "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"
        ]
      }
    }
  ]
}