{
  "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": "2026-04-15",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Terminated",
      "city": "Houston",
      "state": "TX",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "80062",
      "recalling_firm": "Cyberonics, Inc",
      "address_1": "100 Cyberonics Blvd",
      "address_2": "N/A",
      "postal_code": "77058-2069",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "AL, CA, CO, DE, FL, GA, ID, IL, IN, ME, MO, MS, NC, NJ, NY, PA, TN, TN, TX, UT, WA and WI",
      "recall_number": "Z-2255-2018",
      "product_description": "VNS Therapy Programmer, Model 3000, v1.0 System",
      "product_quantity": "252",
      "reason_for_recall": "Certain Model 3000 programming events can result in miscalculation of parameters stored in the Models 103, 104, 105, and 106 generators.  During these programming events, the miscalculations can lead to:   \"  Delivery of more stimulation than intended, resulting in painful stimulation or other common side effects (Model 106 only);   \"  No stimulation in the case of device disablement (Burst Watchdog Timeout), resulting in no therapy to the patient (Model 106 only);  \"  Delivery of less stimulation than intended, resulting in therapeutic settings not being achieved within device specification (Models 103, 104, 105, or 106); and/or   \"  Delays or absence of the 75% and 50% battery life indicators displayed by the programming software (Models 103, 104, 105, or 106).",
      "recall_initiation_date": "20171113",
      "center_classification_date": "20180619",
      "termination_date": "20221031",
      "report_date": "20180627",
      "code_info": "Serial Numbers:  FMT77F2, FKR57F2, FCR77F2, CJR77F2, BNT77F2, BNS77F2, 7XR77F2, 7XP57F2, 79R77F2, 90S77F2, 97Q57F2, 6NT77F2, 9GP57F2, 6KQ57F2,   B7Q57F2, 57P57F2, 55T77F2, J6R57F2, HWR77F2, 1G7G1F2, 1JR57F2,   9XP57F2, 4LR77F2, 4GT77F2, 4GR57F2, 2DT77F2, G2S77F2, FVQ77F2,   G5T77F2, FDQ57F2, F5R57F2, F2R57F2, F1Q57F2, GHS77F2, DVR77F2,   DNP57F2, DMYB7F2, DJS77F2, D1R57F2, CVQ57F2, H4R57F2, 85S77F2,   89T77F2, 8LYB7F2, 97YB7F2, 6MQ57F2, 6CQ57F2, 5HS77F2, JLQ57F2,   JGS77F2, 11R57F2, 1TQ57F2, 1YR77F2, 2DR77F2, ,FXP57F2 , FTR77F2,  FPQ57F2, FNQ57F2, FLYB7F2, FFP57F2, GGT77F2, GSQ57F2, CMS77F2,  H1R77F2, H3R57F2, 7LS77F2, 9KR57F2, 9NS77F2, 65R57F2, B8R77F2,   B9T77F2, 5D0C7F2, B9YB7F2, BJR57F2, JCQ57F2, J9YB7F2, HMYB7F2,  CDQ57F2, FXQ57F2, G5S77F2, G3R77F2, FRQ57F2, G7YB7F2, FLS77F2,  G90C7F2, FGR77F2, FFT77F2, G9Q57F2, FCT77F2, G9R57F2, F9YB7F2,   F9S77F2, F8T77F2, GDQ57F2, F7R57F2, F4T77F2, DWR77F2, DTR77F2,   DSQ57F2, GMQ57F2, DLS77F2, DH0C7F2, DGS77F2, DGP57F2, GZR77F2,  D1Q57F2, CSQ57F2, CLS77F2, C9YB7F2, C70C7F2, H1R57F2, C1R77F2,   7MS77F2, 78YB7F2, 9SQ57F2, 5VQ57F2, 5RQ57F2, B60C7F2, 5NQ57F2,  5MR77F2, 5KS77F2, B8T77F2, BHP57F2, BJR77F2, 4JS77F2, H4T77F2,   JZQ57F2, JMS77F2, JMQ57F2, JG0C7F2, JBQ57F2, J8T77F2, ,HZQ57F2,  J7R57F2, HVR77F2, HTP57F2, HNS77F2, HMQ57F2, HKQ57F2, H7S77F2,   D3R57F2, 1CQ57F2, 1HT77F2, 1MYB7F2, 2CP57F2, 2LYB7F2, CLYB7F2,   CMYB7F2, B4R77F2, B2S77F2, B0R57F2, 9QS77F2, D8Q57F2, 960C7F2,  95T77F2, 8JR77F2, 8HR57F2, BXP57F2, BWR77F2, BTQ77F2, C8YB7F2,   C60C7F2, BLR77F2, BLQ57F2, BGR77F2, BGP57F2, CHQ57F2, CKR57F2,  CPP57F2, CSR77F2, CTQ77F2, CXR77F2, 9MS77F2, 9JR77F2, 9DQ57F2,  D7S77F2, 94T77F2, 8PQ57F2, BWQ77F2, BSR77F2, BNQ57F2, C9R57F2,  C8R57F2, C5R57F2, CF0C7F2, C3R57F2, CFP57F2, BDT77F2, B9S77F2,  B5R57F2, CPQ57F2, B4R57F2, D2R57F2, 9KQ57F2, D5R77F2, 9F0C7F2,  980C7F2, D9YB7F2, 8WR77F2, DB0C7F2, 9P7G1F2, D3S77F2, D6R57F2,  D7R57F2, 9CR77F2, 9G0C7F2, 96R57F2, DFP57F2, C0S77F2, BN7G1F2,  BQ7G1F2, C8S77F2, CB0C7F2, CCR77F2, BHR57F2, CHP57F2, BCR77F2,  BBR77F2, BB0C7F2, B90C7F2, B70C7F2, B2R57F2, 9VP57F2, 9TQ57F2,  9GR57F2, 9FP57F2, 9BS77F2, ,98R57F2 ,D80C7F2, 970C7F2, D8YB7F2,  95R77F2, 8YR77F2, C1R57F2, C80C7F2, C3R77F2, CNS77F2, 9VQ77F2,  D4T77F2, 9DR77F2, 91R57F2, 8VQ77F2, 8RQ57F2, DBS77F2, 8JS77F2,  C0R57F2, BTR77F2, BMYB7F2, BKR77F2, BBP57F2 and B8S77F2"
    }
  ]
}