{
  "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": "2026-09-05",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "179188",
      "product_res_number": "Z-1563-2020",
      "event_date_initiated": "2020-02-04",
      "event_date_created": "2020-03-24",
      "recall_status": "Open, Classified",
      "res_event_number": "84723",
      "product_code": "LYJ",
      "pma_numbers": [
        "P970003"
      ],
      "product_description": "VNS Therapy Programmer, Model 3000 used with Models 103, 104, 105, 106, or 8103 VNS Therapy generators.",
      "code_info": "Model 3000 version 1.6",
      "firm_fei_number": "1000117004",
      "recalling_firm": "LivaNova USA Inc",
      "address_1": "100 Cyberonics Blvd",
      "city": "Houston",
      "state": "TX",
      "postal_code": "77058-2069",
      "additional_info_contact": "281-228-7200",
      "reason_for_recall": "False positive warning may occur after: 1) VNS Generator interrogated at 0mA normal output current, 2) Generator programmed to non-0mA output current, 3) In-session re-interrogation performed. Users instructed to lower output current and widen pulse width. Only system diagnostic testing evaluates output current. Users may conclude device malfunction, could lead to medical/surgical intervention.",
      "root_cause_description": "Software Design Change",
      "action": "On 02/04/20, Urgent Medical Device Correction notices were mailed to Doctors, who were informed the following:\n\nWhich Patients are Potentially Impacted?\nBecause the false positive warning message only appears if the generator is initially interrogated at 0mA, there are only certain scenarios where the issue may appear:\n- After initial implant, when the device is programmed on for the first time;\n- Following an MRI, after the device was programmed to 0mA per labeling instructions; or\n- Resuming therapy following previous device disablement due to an adverse event or device issue.\n\nActions to be taken by the Physician:\n1. If you obtain the low output current warning message, follow the Physician's Manual instructions to perform a System Diagnostics test after initial interrogation and programming before utilizing in-session re-interrogation.\n2. During programming visits, always perform System Diagnostics testing immediately after any programming operations are performed to ensure the device is delivering programmed stimulation as intended.\n2. Please complete and return the attached Customer Response Form.\n\nPlease ensure that this notice is communicated to all personnel within your organization who need to be aware of it.\n\nTo report a complaint or for technical support, contact the Customer Quality team at cservices@livanova.com or (866) 882-8804.\n\nActions to be taken by Company:\nAn update to the software is in development to eliminate this false positive low output current message. Information on availability of the software update will be shared in future communications.\n\nNew users will be trained on proper use of programming system, including the appropriate sequence of use of diagnostic testing.",
      "product_quantity": "2683",
      "distribution_pattern": "U.S.: LA, ID, AZ, UT, KY, VA, TN, NY, SC, IL, IN, NC, WA, CA, OH, FL, PA, NJ, CO, TX, RI, MD, HI, OR, MA, NE, MO, OK, MS, MN, SD, VT, AR, WV, WI, MI, AL, KS, DE, NM, GA, ND, AK, MT, ME, NV, DC, MO, WY, IA, CT.\n\nCanada, and Israel.",
      "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"
        ]
      }
    }
  ]
}