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.
Recalled Catheter Model Numbers
SC-014-135
SC-018-090
SC-035-065
SC-035-135
SC-014-150
SC-018-150
SC-035-090
SC-035-150
Effected Lot Numbers
7828282, 7792290, 7792584, 7805570, 7805797, 7806392, 7820252, 7790666, 7791887, 7803307, 7835331, 7822400, 7822593, 7800446, 7800555, 7800756, 7800779, 7800809, 7801822, 7801875, 7803305, 7803306, 7820273, 7834779, 7834845, 7824905, 7832205
For more information, please contact ev3, Inc. at 1-800-716-6700, Monday - Friday, 8:00 AM - 5:00 PM, Central Time. All affected product should be returned to the firm.
Class 1 is the most serious of all medical recalls and involve situations in which there is a reasonable probability that use of these products will cause serious adverse health consequences or death.
If a defective medical device has injured you or a loved one, it is critical to contact an experience medical attorney as soon as possible. The medical attorneys at Arnold & Itkin LLP help those who have suffered serious medical injuries as the result of defective medical devices get the care they need and the compensation they deserve. For a Free consultation concerning your medical injury, please fill out the FREE Case Review form on this page or call 866-222-2606 today.
