Cyberonics Vagus Nerve Stimulator — Class II medical device recall Z-0280-2016
Terminated recall by Cyberonics, Inc, reported 2015-11-25, distributed in CA, CO, FL, GA, IL, IN, KS, KY…. Certain Model 106 Pulse Generators demonstrate delays in sensing during use of the 'Verify Heartbeat Detection
| Recall number | Z-0280-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Cyberonics, Inc, Houston, TX, United States |
| Recall initiated | 2015-10-07 |
| Classified | 2015-11-17 |
| Reported by FDA | 2015-11-25 |
| Terminated | 2017-09-06 |
| Distributed | CA, CO, FL, GA, IL, IN, KS, KY, MI, NC, NY, OH, OR, PA, TX, UT, WV |
| Quantity | 27 units |
| Serial numbers | 37719, 37899, 38123, 38414, 38428, 39385, 39531, 39607, 39801, 39821, 40037, 40048, 40249, 40251, 40271, 40354, 40428, 40488, 40526, 40603, 40751, 41000, 41109, 41152, 41805 and 2 more |
| Model numbers | 106 |
Product
Cyberonics Vagus Nerve Stimulator (VNS) Therapy AspireSR Generator, Model 106
Reason for recall
Certain Model 106 Pulse Generators demonstrate delays in sensing during use of the 'Verify Heartbeat Detection' feature and exhibit potential for decreased battery longevity.
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-0280-2016. 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.