Processing Magazine

J&J Recalls 130,000 Balloon Catheters

January 28, 2008
A unit of Johnson & Johnson has recalled more than 130,000 balloon catheters used in surgery to clear arteries clogged with plaque, the Associated Press reported.

The Food and Drug Administration announced the recall on its Web site recently, saying the balloons do not deflate properly, and could potentially cause heart attack or death. A spokesman for Johnson & Johnson''s Cordis Corp. said no deaths have been reported as a result of the defect.

Cordis recalled the catheters Jan. 14, sending letters to physicians warning them not to use the devices. About 60,000 of the recalled catheters were distributed in the U.S., with the rest sold overseas.

The devices are labeled Fire Star and DuraStar Dilation Catheters. Both models were manufactured in Mexico and distributed worldwide between March 2007 and January 2008.

A spokesman for Cordis said the recall is not expected to materially impact company earnings.