Class II — LivaNova USA Inc
| Recalling firm | LivaNova USA, Inc. |
|---|---|
| Registered facility | LivaNova USA, Inc. (the firm's only registered facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | 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. |
| Product | VNS Therapy® AspireSR® Generator |
| Quantity | 134 generators |
| Distribution | U.S.: 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, and WA O.U.S.: Argentina, Finland and Peru |
| Initiated | 2020-09-28 |
| Classified | 2020-11-17 |
| Terminated | 2022-11-02 |
| Recall number | Z-0462-2021 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — LivaNova USA Inc (Z-0462-2021).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/86570/
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