Class 2 Device Recall AMPLATZER Exchange System

• Date Initiated by Firm: October 02, 2006
• Date Posted: December 19, 2006
• Recall Status: Terminated on October 09, 2008
• Recall Number: Z-0256-2007
• Recall Event ID: 36440
• PMA Number: P020024
• Product Classification: Cardiac Septal Occluder Delivery System - Product Code GBK
• Product: Amplatzer Cardiac Septal Occluder delivery system Exchange Systems labeled as follows: a) AMPLATZER Exchange System, Order no. 9-EXCH-6F-180/80, 9-EXCH-8F-180/80, 9EXCH-9F-45/80, 9-EXCH-12F-45/80. [Breakdown of order no. ''9-EXCH-6F180/80'' is as follows: 9-EXCH, French size (6F) - degree angle curve (180) / usable length in cm (80).] and b) the following devices are not approved for US distribution: AMPLATZER TorqVue Exchange System, Order no. 9-EITV09F45/80, 9-EITV12F45/80, 9-EITV06F180/80, 9-EITV08F180/80. Manufactured in USA, Sterile EO. Headquarters AGA Medical Corporation, 682 Mendelssohn Avenue, Golden Valley, MN 55427 U.S.A. The Exchange System is comprised of a delivery sheath, delivery cable, dilator, loading device and pin vise.
• Code Information: Order no. 9-EXCH6F-180/80, Lot Numbers: M05F10-13, M06F22-25. Order no. 9-EXCH8F-180/80, Lot numbers: M04D01-06, M04E27-21, M05C23-13. Order no. 9EXCH9F-45/80, Lot Numbers: M03L18-54, M05A12-09, M05D19-10, M05D18-47, M05E23-37, M05G15-06, M05H18-36. Order no. 9-EXCH12F-45/80, Lot Numbers: M05A13-23, M05B04-11, M05B14-08, M05C30-11, M05E02-19, M05H08-20. the following devices are not approved for US distribution: AMPLATZER TorqVue Exchange System, Order no. 9-EITV09F45/80, Lot numbers: M06A05-31, M05L15-24. Order no. 9-EITV12F45/80, Lot numbers: M06A05-33, M05L15-26. Order no. 9-EITV06F180/80, Lot numbers: M06D19-51. Order no. 9-EITV08F180/80, Lot numbers: M05L15-32, M06G26-02.
• FEI Number: 3005334138
• Recalling Firm/ Manufacturer: AGA Medical Corporation; 682 Mendelssohn Ave N; Golden Valley MN 55427-4306
• Manufacturer Reason for Recall: AGA Medical has found that microscopic tears can occur in the delivery system sterile packaging under accelerated stress testing with routine shipping configurations. These microscopic tears are a potential breach of the sterile barrier. AGA has no confirmed complaints or adverse events related to this failure mode.
• FDA Determined Cause: Other
• Action: An Urgent Recall Notice, dated 09/29/06, was sent to customers via facsimile or email and via Federal Express. The letter describes the issue and what product is affected. Unexpired product that is returned to AGA will be replaced. A response form is asked to be returned to AGA.
• Quantity in Commerce: 1,967
• Distribution: Worldwide, including USA, Puerto Rico, Algeria, Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, China, Colombia, Costa Rica, Cuba, Denmark, El Salvador, Finland, France, Germany, Greece, Guatemala, Hungary, Iceland, India, Indonesia, Israel, Italy, Japan, Jordan, Korea, Kuwait, Malaysia, Moroc, Mexico, Norway, Pakistan, Peru, Phillipines, Poland, Portugal, Saudi Arabia, Singapore, Slovak Republic, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, The Netherlands, Tunisia, Turkey, United Kingdom, Uruguay, Venezuela, and Vietnam.

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.