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NanoCross catheters recalled

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The company ev3 has initiated a voluntary recall of the NanoCross .014” OTW PTA Dilation Catheter because of the potential of cracking or breaking during use. The FDA has classified this as a class I recall.

A cracked or broken catheter shaft could result in the inability to inflate or deflate the balloon, resulting in material separation and possible embolization. This could cause unplanned intravascular or open surgery, vasospasm, prolonged tissue ischemia, bleeding and/or death.

The NanoCross .014” OTW PTA Dilation Catheter is used to dilate stenosis in the iliac, femoral, iliofemoral, popliteal, infra-popliteal and renal arteries, and to treat obstructive lesions of native or synthetic arteriovenous dialysis fistulae.

The recall affects certain lots of the NanoCross .014” OTW PTA Dilation Catheters manufactured between May 27, 2010 and October 18, 2010. Only the catheters from the lots specified on this site are affected by the recall.

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