FDA: Class I recall of Abbott coronary dilatation catheters

Editor's Note

The Food & Drug Administration on February 19 identified the recall by Abbott Vascular of its NC Trek RX and NC Traveler RX Coronary Dilatation Catheters (diameter 4.0 mm, 4.5 mm, and 5.00 mm) as Class I, the most serious.

The recall was initiated because of failure of the balloons to deflate as intended. The issue is because of weaker material close to the balloon bond resulting from excessive exposure to heat during the manufacturing process.

Abbot has received 13 complaints related to this issue, and one death has been reported.

Distribution dates were August 2019 to January 2020.