AGA Medical Corporation AMPLATZER Delivery System 180-degree curve, order no. 9-DEL-5F-180/60. Product is labeled as Sterile EO. Amplatzer Occluder Device and Delivery System is comprised of delivery sheath, delivery cable, dilator, loading device and pin vise. The Delivery and Exchange Systems are placed onto polyboard backing cards. The backing card is then placed into a smaller of 2 Tyvek pouches. The pouch is then placed inside a larger Tyvek pouch. The kit is assembled at AGA and then sterilized by Steris, Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
AMPLATZER Delivery System 180-degree curve, order no. 9-DEL-5F-180/60. Product is labeled as Sterile EO. Amplatzer Occluder Device and Delivery System is comprised of delivery sheath, delivery cable, dilator, loading device and pin vise. The Delivery and Exchange Systems are placed onto polyboard backing cards. The backing card is then placed into a smaller of 2 Tyvek pouches. The pouch is then placed inside a larger Tyvek pouch. The kit is assembled at AGA and then sterilized by Steris,
Brand
AGA Medical Corporation
Lot Codes / Batch Numbers
M02A28-23, M03A09-11, M03B20-15, M03H06-07, M03J19-05, M03L18-49, M04B02-02, M04C01-19, M04E18-13, M04J13-15
Products Sold
M02A28-23, M03A09-11, M03B20-15, M03H06-07, M03J19-05, M03L18-49, M04B02-02, M04C01-19, M04E18-13, M04J13-15
AGA Medical Corporation is recalling AMPLATZER Delivery System 180-degree curve, order no. 9-DEL-5F-180/60. Product is labeled as Steril due to Tubing utilized in the manufacture of the AMPLATZER Delivery and Exchange System sheaths and dilators was in some cases manufactured by our supplier o. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Tubing utilized in the manufacture of the AMPLATZER Delivery and Exchange System sheaths and dilators was in some cases manufactured by our supplier outside of process parameters; causing a residue to be left on the inside of the tubing.
Recommended Action
Per FDA guidance
Recall notices were sent via e-mail 11/22/04 to physicians, hospitals and distributors who received affected product. Hard copies of the Recall Notices were sent to all customers (international and domestic) via Federal Express 11/22-24/04. A form that is attached to the Recall Notice asks for customers to fill out quantities of affected product and to return the affected product to AGA Medical.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026