TAXUS Express Paclitaxel-Eluting MONORAIL Coronary Stent System (3.5 x 32mm). On August 5, 2004 an additional 38 lots we

FDA device recall Z-1052-04 · posted 2004-07-20 · Terminated

Recall details

Recalling firm

Boston Scientific Scimed

Reason for recall

On a few occasions the balloon has failed to deflate within one minute after deployment of the stent.

Action taken

July 2 and 16, 2004 recall letters were sent to user accounts, such as Hospitals and clinics of the need to recall TAXUS Express2 Paclitaxel-Eluting and Express 2 Coronary Stent Systems. Recall was due to characteristics in the delivery catheters that had the potential to impede balloon deflation during a coronary angioplasty procedure, a condition known as focal neckdown. An additional 38 lots were added to the recall on August 5, 2004, for the same reason.

Root cause

Other

Status

Terminated

Product code

NIQ

Quantity affected

205,983 units plus additional 3,000 units recalled on 8/5/04.

Distribution

Nationwide and Canada

Date initiated

2004-07-01

Date posted

2004-07-20

Date terminated

2006-02-22

Location

Maple Grove, MN