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 | Unintended warning message displayed on generators programmed with a Model 3000 v.1.0.2.2 programmer. |
| Product | VNS Therapy Programming System, Rx Only, Model 3000, v1.0.2.2 |
| Quantity | 243 devices total |
| Distribution | Distributed domestically to AZ, CA, GA, IA, IL, IN, MO, MT, NC, NY, PA, SD, TN, TX, WA, WI. |
| Initiated | 2018-01-24 |
| Classified | 2018-07-28 |
| Terminated | 2023-11-29 |
| Recall number | Z-2572-2018 |
| 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-2572-2018).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/80424/
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