AGA Medical Corporation AMPLATZER Exchange System 180-degree curve, order no. 9-EXCH-6F-180/80. Product is labeled as Sterile EO. The AMPLATZER Exchange System is comprised of the identical components as the AMPLATZER Delivery System, which is comprised of delivery sheath, delivery cable, dilator, loading device and pin vise. The only exception is the dilator component in the Exchange System has a larger inner lumen to allow passage over an AMPLATZER delivery cable. Exchange Systems are placed onto polyboard Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
AMPLATZER Exchange System 180-degree curve, order no. 9-EXCH-6F-180/80. Product is labeled as Sterile EO. The AMPLATZER Exchange System is comprised of the identical components as the AMPLATZER Delivery System, which is comprised of delivery sheath, delivery cable, dilator, loading device and pin vise. The only exception is the dilator component in the Exchange System has a larger inner lumen to allow passage over an AMPLATZER delivery cable. Exchange Systems are placed onto polyboard
Brand
AGA Medical Corporation
Lot Codes / Batch Numbers
M02B14-09, M02C25-16
Products Sold
M02B14-09, M02C25-16
AGA Medical Corporation is recalling AMPLATZER Exchange System 180-degree curve, order no. 9-EXCH-6F-180/80. Product is labeled as Steri 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