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.
This recall has been terminated (originally issued December 17, 2021).
- Recall Initiated
- December 17, 2021
- Terminated
- January 8, 2024
- Recall Number
- Z-0787-2022
- Quantity
- 4
- Official Source
- View on FDA website ↗
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
Lot / Code Info
CP5 Drive Unit Serial Numbers: 60E03336 60E03339 60E03344 60E03347
Root Cause
Process control
Action Taken
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.