VNS Therapy DemiPulse Generator Model 103 and VNS Therapy DemiPulse… — Class II medical device recall Z-1526-2015
Terminated recall by Cyberonics, Inc, reported 2015-05-06, distributed in AR, AZ, CA, FL, GA, IN, MI, NV…. The pulse generators have a lower battery longevity than specified in their design requirement as a result of
| Recall number | Z-1526-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Cyberonics, Inc, Houston, TX, United States |
| Recall initiated | 2015-03-06 |
| Classified | 2015-04-27 |
| Reported by FDA | 2015-05-06 |
| Terminated | 2015-10-09 |
| Distributed | AR, AZ, CA, FL, GA, IN, MI, NV, TX |
| Quantity | 13 units |
| Serial numbers | 37627, 38473, 38539, 41446, 42887, 43491, 44186, 44339, 44391, 44443, 44455, 44510, 50715 |
| Model numbers | 103, 104 |
Product
VNS Therapy DemiPulse Generator Model 103 and VNS Therapy DemiPulse Duo Generator Model 104; CYBERONICS, INC.
Reason for recall
The pulse generators have a lower battery longevity than specified in their design requirement as a result of the devices being inadvertently left in a programmed ON state during manufacture.
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-1526-2015. 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.