FDA Medical Device Recalls (openFDA)
LivaNova Deutschland GmbH: 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 number
- Z-0787-2022
- Recalling firm
- LivaNova Deutschland GmbH
- 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.
- Status
- Terminated
- Initiated
- 2021-12-17
- Posted
- not on file
- Terminated
- 2024-01-08
- Reason
- One ferrite ring expected to be installed on centrifugal pump system power cable may not be present.
- Root cause
- Process control
- Action
- 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.
- Quantity
- 4
- Distribution
- US distribution in states of FL, TX, and NE
- Lot, serial or model codes
- CP5 Drive Unit Serial Numbers: 60E03336 60E03339 60E03344 60E03347
- 510(k) numbers
- ["K112225"]
- PMA numbers
- not on file
- Product code
- DWA
- Firm FEI
- 3002808267
- Firm city
- Munich
- Firm state
- not on file
- Firm country
- Germany
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28