AMPLATZER Delivery System 45-degree curve, order no. 9-DEL-9F-45/80. Product is labeled as Sterile EO. Amplatzer Occlude

FDA device recall Z-0355-05 · posted 2004-12-24 · Terminated

Recall details

Recalling firm

AGA Medical Corporation

Reason for recall

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.

Action taken

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.

Root cause

Other

Status

Terminated

Product code

GBK

Quantity affected

13,168

Distribution

Product has been distributed throughout the US and Internationally, including Canada, Europe and Australia.

Date initiated

2004-11-23

Date posted

2004-12-24

Date terminated

2006-12-26

Location

Golden Valley, MN