Class 2 Device Recall Aortic Perfusion Cannula

• Date Initiated by Firm: April 18, 2006
• Date Posted: June 09, 2006
• Recall Status: Terminated on June 11, 2008
• Recall Number: Z-1089-06
• Recall Event ID: 35291
• 510(K)Number: K831769
• Product Classification: Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass - Product Code DWF
• Product: Aortic Perfusion Cannula with plastic tip, 22 Fr. x 28 cm Edwards Lifesciences
• Code Information: REF: A3221190A. Lot Number 58194673
• Recalling Firm/ Manufacturer: Edwards Lifesciences Research Medical, Inc.; 6864 Cottonwood St; Midvale UT 84047-1083
• For Additional Information Contact: 801-565-6100
• Manufacturer Reason for Recall: Due to potential embrittlement of the plastic tip which may crack or separate during use.
• FDA Determined Cause: Other
• Action: Consignees were notified by letter and visit beginning 04/18/2006.
• Quantity in Commerce: 320 units (Domestic)
• Distribution: CA, CT, FL, IN, KS, MA, MI, TN, TX. No Military or government consignees. Foreign distribution to Australia, Chile, EU, India, Singapore, Taiwan
• 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