ev3 Endovascular Inc. Trailblazer Support Catheter: Class I Recall
MedSun: Newsletter #45, February 2010

FDA MedWatch Safety Alert

This device 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.

Additional Information:

FDA MedWatch Safety Alert. ev3 Endovascular Inc. Trailblazer Support Catheter: Class I Recall January 5, 2010.
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm196266.htm