Class III — LivaNova Deutschland GmbH
| Recalling firm | LivaNova Deutschland GmbH |
|---|---|
| Registered facility | LivaNova Deutschland GmbH (the firm's only registered facility) |
| Classification | Class III |
| Status | Terminated |
| Reason | One ferrite ring expected to be installed on centrifugal pump system power cable may not be present. |
| Product | Sorin Centrifugal Pump System, CP5, Drive Unit (Catalogue Item #60-01-04, UDI: 04033817900948) used in an HLM S5/C5 System configuration. A cardiopulmonary bypass speed control device. |
| Quantity | 4 |
| Distribution | US distribution in states of FL, TX, and NE |
| Initiated | 2021-12-17 |
| Classified | 2022-03-15 |
| Terminated | 2024-01-08 |
| Recall number | Z-0787-2022 |
| 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 Deutschland GmbH (Z-0787-2022).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/89312/
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