ev3 Recalls NanoCross™ .014" OTW PTA Dilatation Catheter
January 07, 2011
ev3, a Covidien company, has initiated a voluntary recall of specific lots of the NanoCrossTM .014" OTW PTA Dilatation Catheter due to the potential for the catheter shaft to crack or break during use. Cracking or breaking of the catheter shaft may result in the inability to inflate or deflate the balloon, and may result in material separation and potential embolization. The device failure may lead to unplanned intravascular or open surgery, significant vasospasm, prolonged tissue ischemia, tissue, injury, infarct, bleeding and/or death.
The voluntary recall affects certain lots of the NanoCross .014" OTW PTA Dilatation Catheters manufactured between May 27, 2010, and October 18, 2010. Only the NanoCross .014" OTW PTA Dilatation Catheters from lot numbers listed below is affected by this action. Learn More.