Class I Recall for Trailblazer Support Catheters


The U.S. Food & Drug Administration (FDA) has issued its most serious Class I recall for the Trailblazer Support Catheter, marketed by ev3 Endovascular, Inc. This type of recall is implemented when there is a reasonable probability that serious adverse health consequences or death could occur from using a product.

The catheter device is inserted into a vein or artery through the skin to direct and support a guide wire for access of blood vessels.  This allows wire exchanges and  provides a delivery route for solutions to diagnose or  treat patients.

Approximately 350 devices are included  in this recall.  They were manufactured from September 11, 2009 through September 29, 2009 and distributed between September 21, 2009 and October 27, 2009. The complete list of model and lot numbers can be found here.

The recall notice warns the Trailblazer Support Catheter might crack near the radiopaque marker band, which could cause serious patient injury such as insufficient oxygen supply to tissues, blood vessel damage, heart attack, limb amputation, unplanned surgery, or death.

On November 6, 2009, ev3 Endovascular, Inc. sent customers a letter detailing the recall. All affected products have since been returned to the company.