A catheter used for various treatments at medical facilities has been recalled by the Food and Drug Administration (FDA) as part of a Class 1 recall. A class 1 recall is the most serious type of action issued by the FDA and involves situations in which there is a reasonable probability that use of these products will cause serious adverse health consequences or death.
The recalled product, the Trailblazer Support Catheter made by ev3 Endovascular Inc., is a device that is introduced into a vein or artery through the skin in order to guide and support a guide wire during access of blood vessels to allow wire exchanges and to provide a passage to deliver solutions to diagnose or to treat patients. The recall was issued because the 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.
The recalled devices were manufactured from September 11, 2009, through September 29, 2009, and distributed from September 21, 2009, through October 27, 2009. Ev3, Inc. sent a notice to all its customers on November 6, 2009, and states that to date all affected products have been returned to the firm.
Any adverse reactions or qualifying problems experienced with this or any other product should be reported to the FDA’s MedWatch Adverse Event Reporting Program at www.fda.gov/MedWatch.