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U.S. Department of Health and Human Services

Safety

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ev3 Endovascular Inc. Trailblazer Support Catheter: Class I Recall

Audience: Vascular healthcare professionals, hospital risk managers

[Posted 01/05/2010] ev3 Endovascular, Inc. and FDA notified healthcare professionals of a Class I Recall of the Trailblazer Support Catheter. 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. See the Recall Notice for a listing of affected model and lot numbers, manufactured from September 11, 2009 through September 29, 2009 and distributed from September 21, 2009 through October 27, 2009.

[01/05/2010 - Recall Notice - FDA]