LivaNova Deutschland GmbH Lindberghstr. 25 Munich Germany 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. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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.
Brand
LivaNova Deutschland GmbH Lindberghstr. 25 Munich Germany
Lot Codes / Batch Numbers
CP5 Drive Unit Serial Numbers: 60E03336 60E03339 60E03344 60E03347
Products Sold
CP5 Drive Unit Serial Numbers: 60E03336 60E03339 60E03344 60E03347
LivaNova Deutschland GmbH Lindberghstr. 25 Munich Germany is recalling Sorin Centrifugal Pump System, CP5, Drive Unit (Catalogue Item #60-01-04, UDI: 04033817900948) used due to One ferrite ring expected to be installed on centrifugal pump system power cable may not be present.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
One ferrite ring expected to be installed on centrifugal pump system power cable may not be present.
Recommended Action
Per FDA guidance
On 12/17/2021, the firm notified affected customers via email using a letter titled, "URGENT MEDICAL DEVICE CORRECTION FA-CP-MUN-2021-001." The letter indicated the following actions to be taken by the customer: Using the attached Customer Response Form (Attachment 1), please respond by email to LivaNova.FSCA@livanova.com to confirm the receipt of this letter and that you have read and understood its content. No further action is requested. A LivaNova authorized technician will contact you to schedule an appointment and correct the devices with the missing ferrite ring. Any affected device currently in use may continue to be used without limitation. For questions regarding this Medical Device Correction, please contact a LivaNova sales rep or send an e-mail LivaNova Quality Assurance Team at LivaNova.FSCA@livanova.com. Please, complete this response form and return it via e-mail to LivaNova.FSCA@livanova.com no later than December 31st, 2021.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
FL, IN, NE, TX
Page updated: Jan 10, 2026