The FDA and ev3 Endovascular have issued a Class I recall of the Trailblazer support catheter, because the device may crack near the radiopaque marker band, resulting in serious patient injury, including insufficient oxygen supply to the tissues, damage to blood vessels, heart attack, limb amputation, unplanned surgery and/or death.
The recall notice, posted on the FDA's Web site, lists the affected model and lot numbers, manufactured from Sept. 11, 2009, through Sept. 29, 2009, and distributed from Sept. 21, 2009, through Oct. 27, 2009.
This catheter supports a guidewire during access of blood vessels to allow wire exchanges and to provide a passage to deliver solutions to diagnose or to treat patients.
On November 6, 2009, the company sent a letter to its customers stating the summary of the problem, affected products, required actions, instructions to locate and remove all affected products.
All affected products have reportedly been returned to the Plymouth, Minn.-based firm.