VNS Therapy¿ AspireSR¿ Generator — Class II medical device recall Z-0462-2021
Terminated recall by LivaNova USA Inc, reported 2020-11-25, distributed in AK, AL, AZ, CA, CO, DC, FL, HI…. Due to an extra digit being inadvertently added to the serial number of a subset of implantable pulse generato
| Recall number | Z-0462-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | LivaNova USA Inc, Houston, TX, United States |
| Recall initiated | 2020-09-28 |
| Classified | 2020-11-17 |
| Reported by FDA | 2020-11-25 |
| Terminated | 2022-11-02 |
| Distributed | AK, AL, AZ, CA, CO, DC, FL, HI, ID, IL, IN, KS, KY, LA, ME, MI, MN, MO, MT, NC, NE, NV, OK, OR, PR, TX, UT, VA, WA |
| Countries outside the US | AR, FI, PE |
| Quantity | 134 generators |
| Reason classes | software |
| Serial numbers | 0105, 1267001, 1267003, 1267006, 1267007, 1267008, 1267009, 1267010, 1267011, 1267012, 1267013, 1267014, 1267015, 1267016, 1267017, 1267018, 1267019, 1267020, 1267021, 1267022, 1267023, 1267024, 1267025, 1267026, 1267027 and 110 more |
| Model numbers | 106 |
Product
VNS Therapy¿ AspireSR¿ Generator
Reason for recall
Due to an extra digit being inadvertently added to the serial number of a subset of implantable pulse generators, they become not compatible with therapy programmers with software version 11.0.4.
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-0462-2021. 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.