AMPLATZER Duct Occluder, Order No. 9-PDA-006, Device Size 10/8mm, Length 8 mm. Sterile EO. Single Use Only. Manufactured

FDA device recall Z-0464-06 · posted 2006-01-31 · Terminated

Recall details

Recalling firm

AGA Medical Corporation

Reason for recall

The pointed end of a screw securing the occluder to the delivery cable could scrape off microscopic fragments of the polytetrafluorethylene (PTFE) plastic lining of the sheath. Those shavings could potentially migrate into a patient's bloodstream.

Action taken

User facilities and distributors were notified via email beginning 09/06/05. Additionally a hard copy of the recall letter was sent via certified mail or Federal Express. AGA requests that the Response Form be completed and faxed or emailed back to them. AGA Medical staff will assist users in returning product distributed within the US.

Root cause

Other

Status

Terminated

Product code

MAE

Quantity affected

18,725 total

Distribution

OUS to the following countries: Algeria, Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, China, Colombia, Costa Rica, Denmark, El Salvador, Finland, France, Germany, Greece, Guatemala,

Date initiated

2005-09-06

Date posted

2006-01-31

Date terminated

2006-12-26

Location

Golden Valley, MN