Medical device maker ev3 Endovascular, Inc. has recalled about 350 Trailblazer Support Catheters. Customers were notified of the recall in November, and all devices have been returned to the firm.
The Food & Drug Administration has deemed this action a Class I recall. Class I recalls are the agency’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.
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.
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.
