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.
FDA Recall Z-0787-2022 · Posted None
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Recalling FirmLivaNova Deutschland GmbH
Recall StatusTerminated
Product CodeDWA
Date Initiated2021-12-17
Date Terminated2024-01-08
Product Quantity4
Reason for Recall
One ferrite ring expected to be installed on centrifugal pump system power cable may not be present.
Firm 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 [email protected] 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 [email protected].
Please, complete this response form and return it via e-mail to [email protected] no later than December 31st, 2021.
Root Cause
Process control
Distribution Pattern
US distribution in states of FL, TX, and NE
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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