VNS Therapy AspireSR Generator Model 106 — Class II medical device recall Z-0659-2016
Terminated recall by Cyberonics, Inc, reported 2016-01-27. Recall being initiated in response to three reports of "Burst Watchdog Timeout" events occurring with the Mode
| Recall number | Z-0659-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Cyberonics, Inc, Houston, TX, United States |
| Recall initiated | 2015-12-18 |
| Classified | 2016-01-15 |
| Reported by FDA | 2016-01-27 |
| Terminated | 2017-03-02 |
| Countries outside the US | AE, AT, BE, CH, CY, CZ, DE, ES, FI, FR, GB, HR, IL, IS, IT, KW, LB, NL, NO, OM, PL, QA, SA, SE, SK |
| Quantity | 4,935 units |
| UPC / GTIN / UDI-DI | 05425025750061 |
| Model numbers | 106 |
Product
VNS Therapy AspireSR Generator Model 106. Indicated for use as an adjunctive therapy in reducing the frequency of seizures.
Reason for recall
Recall being initiated in response to three reports of "Burst Watchdog Timeout" events occurring with the Model 106 AspireSR Generator, resulting in a device reset condition where stimulation output is disabled.
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-0659-2016. 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.