{
  "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": "160846",
      "product_res_number": "Z-0555-2018",
      "event_date_initiated": "2017-12-02",
      "event_date_created": "2018-02-08",
      "recall_status": "Terminated",
      "event_date_terminated": "2018-08-06",
      "res_event_number": "78914",
      "product_code": "LYJ",
      "pma_numbers": [
        "P970003"
      ],
      "product_description": "VNS(R) Therapy Programmer, GMDN:  44077, Model 3000 v1.0.2.2\n\n\nIntended Use/Indications: United States Indications for Use: Epilepsy : The VNS Therapy System is indicated for use as an adjunctive therapy in reducing the frequency of seizures in patients 4 years of age and older with partial onset seizures that are refractory to antiepileptic medications. Depression : VNS Therapy is indicated for the adjunctive long-term treatment of chronic or recurrent depression for patients 18 years of age or older who are experiencing a major depressive episode and have not had an adequate response to four or more adequate antidepressant treatments.",
      "code_info": "Part Number:  10-0011-0500 Serial number/UDI:  8LYB7F2/010542502575039911170920218LYB7F29910-0011-0500 D80C7F2/01054250257503991117092921D80C7F29910-0011-0500",
      "firm_fei_number": "1000117004",
      "recalling_firm": "Cyberonics, Inc",
      "address_1": "100 Cyberonics Blvd",
      "city": "Houston",
      "state": "TX",
      "postal_code": "77058-2069",
      "additional_info_contact": "Joan Ceasar\n281-228-7260",
      "reason_for_recall": "Two Model 3000 Programmers were distributed in error by prior to FDA approval of version 1.0.2.2 software.",
      "root_cause_description": "Employee error",
      "action": "The units were collected by visit on December 21, 2017 and December 28, 2017 from the physicians.  Both programmers have been successfully removed from the customers and no further actions are being proposed.\n\nFor further questions, please call (281) 228-7260.",
      "product_quantity": "2 units",
      "distribution_pattern": "US Distribution to the states of : CO and ND",
      "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"
        ]
      }
    }
  ]
}