Class III — LivaNova USA Inc.
| Recalling firm | LivaNova USA, Inc. |
|---|---|
| Registered facility | LivaNova USA, Inc. (the firm's only registered facility) |
| Classification | Class III |
| Status | Terminated |
| Reason | Perfusion tubing pack was packaged with the incorrect cuvette. |
| Product | LivaNova SMART PERFUSION PACK INSPIRE 8S - Product Usage: The affected product is a perfusion tubing pack use in surgical procedures requiring extracorporeal support. The perfusion tubing packs include the cuvette used with equipment to monitor blood. |
| Quantity | 27 packs |
| Distribution | US Nationwide distribution in the state of IL. |
| Initiated | 2019-07-03 |
| Classified | 2020-02-27 |
| Terminated | 2021-07-09 |
| Recall number | Z-1389-2020 |
| 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 III recall — LivaNova USA Inc. (Z-1389-2020).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/84732/
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