Class 2 Device Recall AORTIC ARCH CANNULA

• Date Initiated by Firm: June 22, 2016
• Date Posted: July 08, 2016
• Recall Status: Terminated on March 27, 2017
• Recall Number: Z-2147-2016
• Recall Event ID: 74490
• 510(K)Number: K943934
• Product Classification: Catheter, cannula and tubing, vascular, cardiopulmonary bypass - Product Code DWF
• Product: AORTIC ARCH CANNULA, Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass (part numbers NA-55X7 and NA-55X8); ; Aortic Arch Cannulae are designed to be used in the extracorporeal circuit during cardiopulmonary bypass surgery. The cannula consists of varying lengths of non-wire reinforced (flexible) polyvinyl chloride tubing that terminates in an angled tip. These devices come in direct contact with the central circulatory system but they are not intended to control, diagnose, monitor or correct a defect.
• Code Information: Lots: 1505600017 ; 1505600018 ; 1506500005 ; 1509200078 ; 1513100112 ; 1513900027 ; 1513900028 ; 1514700045 ; 1516600192 ; 1516800126 ; 1517800004 ; 1519500037 ; 1520100049 ; 1520100050 ; 1520900031 ; 1520900033 ; 1521600126 ; 1523000093 ; 1523600120 ; 1525100023 ; 1525800026 ; 1526500032 ; 1526500033 ; 1526500034 ; 1526500072 ; 1527200050 ; 1527200051 ; 1527200052 ; 1527800163 ; 1529300026 ; 1529300027 ; 1529300028 ; 1533500033 ; 1534200034 ; 1601900027 ; 1601900028
• Recalling Firm/ Manufacturer: Sorin Group USA, Inc.; 14401 W 65th Way; Arvada CO 80004-3503
• For Additional Information Contact: Carrie Wood; 303-467-6461
• Manufacturer Reason for Recall: Sorin Group USA is recalling Aortic Arch Cannulae (part numbers NA-55X7 and NA-55X8) because the distal end may be less than specified. The defective cannula are showing an angle that is about 15-20 degrees instead of approximately 45 degrees.
• FDA Determined Cause: Process control
• Action: The firm, LivaNova, sent an "Urgent Safety Alert" field communication letter dated June 22, 2016 via certified mail to consignees. The letter described the product, problem and actions to be taken. The consignees were instructed to: check your inventory to determine if you own Cannulae, if no inventory, complete the response form and return it per instructions indicated on form.; check the tip angle to determine if it is conforming to specifications, if specifications not met, file a complaint through your normal process whether you decide to keep it, use it or return it to Sorin Group; If you are not willing to use it, return affected product parts to Sorin Group USA,; contact Customer Service at 1-800-650-2623 or email CustomerService@livanova,com to have a RMA issued, and complete and return the Customer Response Form no later than July 20, 2016 via Fax at 303-467-6502 or by e-mail to USFSN@livanova.com. If you need support for the execution of these actions, please contact your LivaNova sales representative or call Customer Service at 1-800-650-2623 (Monday to Friday 8AM to 5PM MT). For questions regarding this notice, please contact Customer Service at 1-800-650-2623 (Monday to Friday 8AM to 5PM MT) or e-mail USFSN@livanova.com.
• Quantity in Commerce: 5740
• Distribution: Worldwide Distribution: US (nationwide) to states of: LA, Ml, MO, OH, TN, and TX; and countries of: Italy and Canada.
• 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 = DWF and Original Applicant = CALIFORNIA MEDICAL LABORATORIES, INC.