ev3, a Covidien company, has initiated a voluntary recall of specific lots of the NanoCross .014" OTW PTA Dilatation Catheter due to the potential for the catheter shaft to crack or break during use, which may result in the inability to inflate or deflate the balloon, and may result in material separation and potential embolization.
ev3 said the device failure may lead to unplanned intravascular or open surgery, vasospasm, prolonged tissue ischemia, injury, infarct, bleeding and/or death.
The US Food and Drug Administration (FDA) has classified the recall as a Class I recall, when the agency believes there is a reasonable probability that the use of the recalled product will cause serious adverse health consequences or death.
The NanoCross 0.014" OTW PTA Dilatation Catheter is intended to dilate stenosis in the iliac, femoral, ilio-femoral, popliteal, infra-popliteal, and renal arteries, and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae.
The voluntary recall affects certain lots of the NanoCross .014" OTW PTA Dilatation Catheters manufactured between 27 May 2010 and 18 October 2010.
ev3 said all affected healthcare facilities have been notified of this action in a letter dated 10 November 2010.