Class 1 recall of the Trailblazer Support Catheter
On January 5, 2010, The FDA issued a MedWatch safety and information report including information about a Class 1 recall of the Trailblazer Support Catheter device.
The recalled catheter is a medical device used to help with the delivery of solutions in the veins or arteries for the treatment of patients.
Class 1 recalls are the most serious type of recall and involve situations in which there is a reasonable probability that use of these products will cause serious adverse health consequences or death.
Specifically, this device may crack near the radiopaque marker band which 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.
Ev3 Endovascular, Inc., has sent a letter to all of its consumers summarizing the problem with the device and requesting the product be returned to their company.
Model Numbers recalled include: SC-014-135, SC-018-090, SC-035-065, SC-035-135, SC-014-150, SC-018-150, SC-035-090, SC-035-150.