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ev3 Endovascular Inc. Trailblazer Support Catheter: Class I Recall - Schlichter, Bogard & Denton Sponsored Links ev3 Endovascular Inc. Trailblazer Support Catheter: Class I Recall - Schlichter, Bogard & Denton A recall of the Trailblazer Support Catheter has been announced by the Food and Drug Administration (FDA) and e3 Endovascular, Inc. By Patricia Woloch Category: 0 Submit your Articles Here! A recall of the Trailblazer Support Catheter has been announced by the Food and Drug Administration (FDA) and e3 Endovascular, Inc. This is a Class I Recall, the most serious classification of recalls, and has been issued in connect with reported adverse events. So far, no deaths have been linked to the defective catheters. Class I Recalls A Class I Recall is the most type of recall issued by the FDA. It means that there is a reasonable probability that the product will cause a serious adverse health event or death if used. The Trailblazer Support Catheter is a medical device, and patients in whom the device was used may not even know its name or function. However, all of the defective catheters have been returned and are no longer in use. The Problem with the Defective Catheters The defective catheters were recalled because they can develop a crack near the radioplaque marker band. If this occurs it can cause: • Insufficient oxygen supply to tissues • Limb amputation • Heart attack • Damage to blood vessels • Unplanned surgery • Death Why the Defective Catheter May Have Been Used There are many types of catheters used for a wide variety of medical procedures. A commonly known type of catheter is the urinary catheter. The recalled catheters were used for endovascular procedures, meaning that they were placed in an artery or vein for treatment of heart conditions. The Trailblazer Support Catheter is used to “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.” Recalled Catheters The recalled catheters were manufactured from September 11, 2009 through September 29, 2009 and distributed from September 21, 2009 through October 27, 2009. In November, 2009, ev3 Endovascular Inc. sent letters to its customers explaining the problem, which products were affected and how to locate and remove the defective medical devices. What You Should Do If you have been injured by a defective medical device, you may be entitled to compensation including compensation for any medical bills associated with correcting the problem and any subsequent medical problems that the defective device has caused. If you have lost a loved one to injuries caused by a defective medical device you may be entitled to compensation for wrongful death. If you believe that you or a loved one has been injured by a medical device that was discovered to be defective or dangerous in any way, please visit the website of Schlichter, Bogard & Denton, experienced defective drug attorneys serving clients nationwide. ev3 Endovascula 0 Subcategories Computers & Internet > Year 2000 Problem > Year 2000 Problem > > ev3 Endovascula 0 Articles