CLASS III Device recall · Reported 23 Mar 2022 · FDA Enforcement Report
Sorin Centrifugal Pump System, CP5, Drive Unit recalled
LivaNova Deutschl is recalling Sorin Centrifugal Pump System, CP5, Drive Unit (, distributed in Florida, Nebraska, Texas. The recall was initiated on 17 Dec 2021 and the FDA has classified it as Class III.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0787-2022
- FDA event ID
- 89312
- Recalling firm
- LivaNova Deutschl, Munich, N/A
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 17 Dec 2021
- FDA classified
- 15 Mar 2022
- Reported
- 23 Mar 2022
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Device Malfunction
- Device type
- Other Medical Devices
Timeline
| 17 Dec 2021 | Recall initiated by company | |
| 15 Mar 2022 | Classified by FDA | +88 days |
| 23 Mar 2022 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
One ferrite ring expected to be installed on centrifugal pump system power cable may not be present.
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
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.
Where it was distributed
US distribution in states of FL, TX, and NE
Questions about this recall
Why was it recalled?
One ferrite ring expected to be installed on centrifugal pump system power cable may not be present.
Which lots are affected?
CP5 Drive Unit Serial Numbers: 60E03336 60E03339 60E03344 60E03347
Where was it sold?
US distribution in states of FL, TX, and NE
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class III mean?
Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from LivaNova Deutschl
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|---|---|---|---|---|---|
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