ev3 Inc. Announces Completion of Voluntary Recall
PLYMOUTH, Minn., Jan. 6, 2010 (GLOBE NEWSWIRE) -- ev3 Inc. today announced that a voluntary Class I recall of the TrailBlazer Support Catheter was completed in December 2009, and all affected units are in the company's possession.
On January 5, 2010, the U.S. Food & Drug Administration (FDA) disclosed the voluntary recall of the TrailBlazer Support Catheter. The voluntary recall was initiated in November 2009 after the company received reports of cracking on the device near the marker band from physicians during the initial limited market release of the device in the U.S. The action was reported to the FDA, and 28 affected accounts were notified by physician letter. The recall of approximately 350 individual catheters was completed and a final closure report was sent to the FDA in December 2009.
No other ev3 devices were involved in this action. In December, ev3 launched a redesigned TrailBlazer Support Catheter that is currently available globally.
About ev3 Inc.
Since its founding in 2000, ev3 has been dedicated to developing innovative and breakthrough technologies for the endovascular treatment of peripheral vascular and neurovascular diseases. The company offers a comprehensive portfolio of treatment options, including the primary interventional technologies used today -- plaque excision systems, peripheral angioplasty balloons, stents, embolic protection devices, liquid embolics, embolization coils, flow diversion devices, thrombectomy catheters and occlusion balloons. More information about the company and its products can be found at http://www.ev3.net.
ev3, the ev3 logo and TrailBlazer are trademarks of ev3 Inc. and its subsidiaries, registered in the U.S. and other countries.
Contact:
ev3 Inc. Investors and Media Julie Tracy, Sr. Vice President, Chief Communications Officer (949) 680-1375 jtracy@ev3.net