Class I Recall for Trailblazer Support Catheters

A Class I recall has been issued for  Trailblazer Support Catheters marketed by ev3 Endovascular, Inc.  According to the recall notice, the Trailblazer Support Catheter may crack near the radiopaque marker band. This may result in serious patient injury, including insufficient oxygen supply to the tissues, damage to blood vessels, heart attack, limb amputation, unplanned surgery, and/or death.

Class I recalls are the Food & Drug Administration's most serious type of recall, and involve situations in which there is a reasonable probability that use of a product will cause serious adverse health consequences or death.

The Trailblazer Support Catheters subject to this recall were manufactured from September 11, 2009 through September 29, 2009 and distributed from September 21, 2009 through October 27, 2009. A complete list of model and lot numbers included in this recall can be found here.

On November 6, 2009, ev3 Endovascular, Inc. sent a letter to their customers detailing the recall. All affected products have since been returned to the firm.The recall included about 350 devices.