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.
This recall has been terminated (originally issued December 19, 2006).
- Company
- Aga Medical Corporation
- Recall Initiated
- October 2, 2006
- Posted
- December 19, 2006
- Terminated
- October 9, 2008
- Recall Number
- Z-0256-2007
- Quantity
- 1,967
- Firm Location
- Golden Valley, MN
- Official Source
- View on FDA website ↗
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.
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.
Lot / Code Info
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.
Root Cause
Other
Action Taken
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.