Cyberonics VNS Therapy AspireHC — Class II medical device recall Z-0858-2015
Terminated recall by Cyberonics, Inc, reported 2014-12-31. The recalled product was distributed with an incorrect serial number printed on the device's label.
| Recall number | Z-0858-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Cyberonics, Inc, Houston, TX, United States |
| Recall initiated | 2014-11-20 |
| Classified | 2014-12-23 |
| Reported by FDA | 2014-12-31 |
| Terminated | 2016-02-08 |
| Quantity | 1 units |
| Reason classes | labeling |
| UPC / GTIN / UDI-DI | 05425025750054 |
| Serial numbers | 31309 |
| Model numbers | 105 |
Product
Cyberonics VNS Therapy AspireHC, Model 105 Generator. The Cyberonics VNS Therapy System consists of the implantable VNS Therapy Generator, the VNS Therapy Lead, and the external programming system used to change the stimulation settings. Indicated for use as an adjunctive therapy in reducing the frequency of seizures.
Reason for recall
The recalled product was distributed with an incorrect serial number printed on the device's label.
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-0858-2015. 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.