Trailblazer Support Catheters Subject to Class I Recall

The <"">Trailblazer Support Catheter marketed by ev3 Endovascular, Inc. has been recalled. The U.S. Food & Drug Administration (FDA) has classified the Trailblazer Support Catheter recall Class I, its most serious recall action.

The Trailblazer Support Catheter is a device that is introduced into a vein or artery through the skin in order to guide and support a guide wire during access of blood vessels to allow wire exchanges and to provide a passage to deliver solutions to diagnose or to treat patients.

About 350 devices are involved in this recall. 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.

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.

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.

Class I recalls involve situations in which there is a reasonable probability that use of a product will cause serious adverse health consequences or death.

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