Class 2 Device Recall AMPLATZER TorqVue Delivery System with Pusher Catheter

• Date Initiated by Firm: October 02, 2006
• Date Posted: December 19, 2006
• Recall Status: Terminated on October 09, 2008
• Recall Number: Z-0257-2007
• Recall Event ID: 36440
• Product Classification: Cardiac Septal Occluder Delivery System - Product Code GBK
• Product: AMPLATZER TorqVue (cardiac septal occluder) Delivery System with Pusher Catheter Order no. 9-TVSP7F-180/80, 9-TVSP8F-180/80, 9-TVSP9F-180/80. [Breakdown of order no. ''9-TVSP-7F-180/80'' is as follows: 9-TVSP, French size (7F) - degree angle curve (180) / usable length in cm (80).] Sterile EO. Single Use Only. CAUTION: Investigational device limited by U.S. Law to Investigational Use. Manufactured in U.S.A. AGA Medical Corporation, 682 Mendelssohn Avenue, Golden Valley, MN 55427 USA. The AMPLATZER TorqVue Delivery System with Pusher Catheter consists of a radiopaque delivery sheath, translucent loading device, dilator, plastic vise, delivery cable, and pusher catheter. The delivery system also includes a high pressure Hemostasis valve with a swivel luer connector. The loading device, also with a full thread swivel luer connector, allows a positive fit and seal between sheath and loader. The translucent loader allows for visualization of the device and potentially the presence of air during transfer of device to the sheath.
• Code Information: Order no. 9-TVSP7F-180/80, Lot Numbers: M03K16-18, M03K24-10, M03K28-30, M03L06-36, M03L12-04, M03M02-10, M04B17-36, M04E18-12, M04E27-16, M04H31-16, M04L15-16, M05C09-09, M05C25-06, M05D20-17, M05E05-20, M05E23-39. Order no. 9-TVSP8F-180/80, Lot Numbers: M03J17-08, M03K16-19, M03K24-11, M03K28-31, M03L06-37, M03L12-05, M03M02-11, M03M30-10, M04B17-37, M04E27-17, M04L08-10, M05A13-05, M05C25-08, M05E05-07, M05F17-10. Order no. 9-TVSP9F-180/80, Lot Numbers: M03J17-09, M03K16-20, M03K24-12, M03K28-32, M03L06-38, M03L12-06, M04E27-18, M04H03-21, M04L15-18, M05D11-12, M05D20-19.
• 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: 14,941
• 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.