Amplatzer Cardiac Septal Occluder Delivery Systems labeled as follows: a) AMPLATZER Delivery System, Order no. 9-DEL-5F-

FDA device recall Z-0255-2007 · posted 2006-12-19 · Terminated

Recall details

Recalling firm

AGA Medical Corporation

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.

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.

Root cause

Other

Status

Terminated

Product code

GBK

Quantity affected

90,516

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

Date initiated

2006-10-02

Date posted

2006-12-19

Date terminated

2008-10-09

Location

Golden Valley, MN