Sorin Centrifugal Pump CP5 Drive Unit missing electromagnetic shielding component
LivaNova is recalling four Sorin Centrifugal Pump CP5 Drive Units because a ferrite ring on the power cable may be missing. The units were distributed in Florida, Texas, and Nebraska.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is an FDA Class III recall with no reported illnesses or injuries. The hazard is a potentially missing electromagnetic shielding component that could theoretically affect device operation, but no actual malfunction has been confirmed. Per the rubric, Class III recalls are typically scored 1-2, and this precautionary recall warrants a score of 2 (Moderate).
Plain-English summary
LivaNova Deutschland GmbH is recalling four units of the Sorin Centrifugal Pump System, CP5, Drive Unit (Catalogue Item #60-01-04) due to a potentially missing ferrite ring on the power cable. The ferrite ring is a component designed to suppress electromagnetic interference (EMI).
The affected units are identified by serial numbers 60E03336, 60E03339, 60E03344, and 60E03347. These units were distributed for use in HLM S5/C5 System configurations, which are cardiopulmonary bypass speed control devices used during cardiac surgery.
If the ferrite ring is not present, the device could be susceptible to electromagnetic interference that may affect its operation. Hospitals and surgical facilities that have received these units should verify the presence of the ferrite ring or contact LivaNova for instructions.
No illnesses or injuries have been reported in connection with this recall.
The recalled product
- 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.
- Manufacturer
- LivaNova Deutschland GmbH
- Hazard
- component-missing
- electromagnetic-interference
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- CP5 Drive Unit Serial Numbers: 60E03336 60E03339 60E03344 60E03347
Distribution
Distributed in 3 states:
- FL
- NE
- TX
Related recalls
Same category
- HighMedtronic DLP Retrograde Cannula cardiopulmonary bypass catheter
FDA (Devices) · 2026-05-27
- HighSwan-Ganz Jr Catheter models recalled due to lumen hub leakage
FDA (Devices) · 2026-05-27
- HighAzurion X-ray System Deaeration Hose May Degrade and Cause Oil Leakage
FDA (Devices) · 2026-05-27
- HighMedtronic DLP Retrograde Cannula Cardiopulmonary Bypass Catheter Recall
FDA (Devices) · 2026-05-27
- HighPhilips Azurion X-Ray Systems Table Movement Control Defect Recall
FDA (Devices) · 2026-05-27