ev3, Inc. issues a Class 1 medical recall of Trailblazer Support Catheters
Recently, ev3, Inc. of Plymouth, Minn., announced a Class 1 medical recall of their Trailblazer Support Catheters.
Trailblazer Support Catheters are used provide access through the skin to veins and arteries. From there, the catheter is used to provide a support channel for guide wires during access of blood vessels and to allow wire exchanges. The catheter is also used to provide a passage for the delivery of solutions to diagnose or treat patients.
The catheters were recalled because the medical device may crack near the catheter’s radiopaque marker band. A radiopaque band is a marking on the device used so that the catheter will show up clearly on an X-ray.
If the device were to crack and shards of broken catheter where left inside the patient’s body, it could result in serious medical injury, including insufficient oxygen supply to tissues, damage to blood vessels, heart attack, limb amputation, unplanned surgery or even death.
The recalled medical devices include product manufactured from September 11-29, 2009.
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