# FDA recall Z-0787-2022

> **LivaNova Deutschland GmbH** · Class III · device recall initiated 2021-12-17.

## 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.

## Reason for recall

One ferrite ring expected to be installed on centrifugal pump system power cable may not be present.

## Distribution

US distribution in states of FL, TX, and NE

## Key facts

- **Recall number:** Z-0787-2022
- **Recalling firm:** LivaNova Deutschland GmbH
- **Classification:** Class III
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2021-12-17
- **Report date:** 2022-03-23
- **Termination date:** 2024-01-08

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Munich, N/A, Germany

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0787-2022

## Citation

> AI Analytics. FDA recall Z-0787-2022. Retrieved 2026-06-02 from https://api.ai-analytics.org/recall/Z-0787-2022. Source: US FDA. Licensed CC0.

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