Recall Z-0364-05 ยท GBK
AGA Medical Corporation
AMPLATZER Exchange System 45-degree curve, order no. 9-EXCH-12F-45/80. 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
| Date | Dec 24, 2004 (initiated Nov 23, 2004) |
| Status | Terminated |
| Reason | 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. |
| Root cause | Other |
| Action | 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. |
| Quantity | 631 |
| Distribution | Product has been distributed throughout the US and Internationally, including Canada, Europe and Australia. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.