Class 2 Device Recall CP5 Centrifugal Pump

• Date Initiated by Firm: October 30, 2017
• Create Date: January 19, 2018
• Recall Status: Terminated on January 26, 2024
• Recall Number: Z-0401-2018
• Recall Event ID: 78594
• 510(K)Number: K112225
• Product Classification: Control, pump speed, cardiopulmonary bypass - Product Code DWA
• Product: CP5 Centrifugal Pump, made up of the drive unit, the emergency system and the pump control panel. It used with an Electrical Remote-Controlled (ERC) tubing clamp and a bubble sensor.
• Code Information: Model No. 60-00-60. Drive Unit: Ref #60-01-04, UDI 04033817900948. Emergency System: Ref #60-01-35, UDI 04033817900955. Pump Control Panel: Ref #60-02-60, UDI 04033817901006.
• FEI Number: 3002808267
• Recalling Firm/ Manufacturer: Sorin Group Deutschland GmbH; Lindberghstr. 25; Munich Germany
• For Additional Information Contact: 800-9864702
• Manufacturer Reason for Recall: Possibility that the automatic line closure by the Electronic Remote-Controlled (ERC) clamp after detection of an air bubble could take longer than is intended by design in the CP5 system.
• FDA Determined Cause: Device Design
• Action: Consignees were notified of the recall via USPS trackable mail, beginning on 10/30/2017. The letter informed customers Instructions included to continue following the Instructions for use, including use of an arterial filter on the arterial line, and that a LivaNova representative will contact them to schedule an upgrade to their device.
• Quantity in Commerce: 1,318 units
• Distribution: Distributed domestically to Distributed internationally to Algeria, Australia, Austria, Azerbaijan, Bahrain, Belarus, Belgium, Canada, China, Colombia, Croatia, Czech Republic, Ecuador, Estonia, Finland, France, Germany, Hong Kong, Iraq, Italy, Japan, Jordan, Kuwait, Libya, Lithuania, Luxembourg, Malaysia, Morocco, Norway, Palestinian Territory, Panama, Peru, Poland, Qatar, Saudi Arabia, Serbia, Singapore, Slovakia, South Africa, Spain, Sweden, Switzerland, The Netherlands, Tunisia, United Kingdom, Vietnam
• 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