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 | For six units, the post-deep cleaning (DC) water sample tested positive for nontuberculous mycobacteria (NTM). |
| Product | SORIN Heater-Cooler System 3T, REF 16-02-85 Intended for use with a Stockert/Sorin S3/S5/C5 heart-lung machine and/or any other heart-lung machine featuring a separate temperature control for extracorporeal perfusion of durations of up to 6 hours. |
| Quantity | 6 devices |
| Distribution | US Distribution to states of: IN, MO, and OH. |
| Initiated | 2018-09-14 |
| Classified | 2019-04-05 |
| Terminated | 2022-09-14 |
| Recall number | Z-1099-2019 |
| 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-1099-2019).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/82365/
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