Class 3 Device Recall CP5

• Date Initiated by Firm: December 17, 2021
• Create Date: March 15, 2022
• Recall Status: Terminated on January 08, 2024
• Recall Number: Z-0787-2022
• Recall Event ID: 89312
• 510(K)Number: K112225
• Product Classification: Control, pump speed, cardiopulmonary bypass - Product Code DWA
• 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.
• Code Information: CP5 Drive Unit Serial Numbers: 60E03336 60E03339 60E03344 60E03347
• Recalling Firm/ Manufacturer: LivaNova Deutschland GmbH ; Lindberghstr. 25; Munich Germany
• For Additional Information Contact: 082 323 010
• Manufacturer Reason for Recall: One ferrite ring expected to be installed on centrifugal pump system power cable may not be present.
• FDA Determined 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 in Commerce: 4
• Distribution: US distribution in states of FL, TX, and NE
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = DWA