VNS Therapy Programmer — Class II medical device recall Z-2255-2018
Terminated recall by Cyberonics, Inc, reported 2018-06-27, distributed in AL, CA, CO, DE, FL, GA, ID, IL…. Certain Model 3000 programming events can result in miscalculation of parameters stored in the Models 103, 104
| Recall number | Z-2255-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Cyberonics, Inc, Houston, TX, United States |
| Recall initiated | 2017-11-13 |
| Classified | 2018-06-19 |
| Reported by FDA | 2018-06-27 |
| Terminated | 2022-10-31 |
| Distributed | AL, CA, CO, DE, FL, GA, ID, IL, IN, ME, MO, MS, NC, NJ, NY, PA, TN, TX, UT, WA, WI |
| Quantity | 252 |
| Reason classes | software |
| Serial numbers | 11R57F2, 1CQ57F2, 1G7G1F2, 1HT77F2, 1JR57F2, 1MYB7F2, 1TQ57F2, 1YR77F2, 2CP57F2, 2DR77F2, 2DT77F2, 2LYB7F2, 4GR57F2, 4GT77F2, 4JS77F2, 4LR77F2, 55T77F2, 57P57F2, 5D0C7F2, 5HS77F2, 5KS77F2, 5MR77F2, 5NQ57F2, 5RQ57F2, 5VQ57F2 and 226 more |
| Model numbers | 3000, V1.0 |
Product
VNS Therapy Programmer, Model 3000, v1.0 System
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).
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2255-2018. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.