Cyberonics VNS Therapy AspireSR — Class II medical device recall Z-0869-2020
Terminated recall by LivaNova USA Inc, reported 2020-02-05, distributed nationwide. This recall is an expansion of Z-3019-2017 and Z-3020-2017, which was initiated to fix the devices premature b
| Recall number | Z-0869-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | LivaNova USA Inc, Houston, TX, United States |
| Recall initiated | 2018-11-16 |
| Classified | 2020-01-27 |
| Reported by FDA | 2020-02-05 |
| Terminated | 2022-12-12 |
| Distributed | Nationwide (US) |
| Quantity | 745 devices |
| Reason classes | packaging |
| Serial numbers | 36519, 36766, 36770, 36776, 36791, 36794, 36800, 36802, 36821, 36824, 36833, 36835, 36845, 36847, 36849, 36869, 36873, 36932, 36935, 36940, 36947, 36951, 36954, 36959, 36961 and 475 more |
| Model numbers | 106 |
Product
Cyberonics VNS Therapy AspireSR, Model 106 Generator, 26-0007-8400/1. The firm name on the label is CYBERONICS, INC., Houston, TX. Vagus nerve stimulator.
Reason for recall
This recall is an expansion of Z-3019-2017 and Z-3020-2017, which was initiated to fix the devices premature battery depletion, caused by electrical leakage on the circuit board assemblies of the Models 105 and 106 generators. *Note this recall occurred in November 2018.
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-0869-2020. 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.