Ev3 recalls peripheral artery dilation catheter

December 23, 2010 by MassDevice staff

Covidien plc subsidiary Ev3 Inc. issues a recall for its NanoCross .014" OTW PTA peripheral artery dilatation catheter; Food & Drug Administration classifies recall as serious.

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Ev3 Inc. initiated a recall for certain lots of its NanoCross .014" OTW PTA dilatation catheter.

The Plymouth, Minn.-based Covidien plc (NYSE:COV) subsidiary is taking the peripheral artery surgical instruments off the shelves because of a potential for the catheter's shaft to crack or break during procedures using balloons to dilate blood vessels.

The failure of the device could result in its "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, injury, infarct, bleeding and/or death," the company said in prepared remarks. The device is intended for 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," according to the company.

The recall only affects NanoCross .014 catheters manufactured between May 27, 2010 and Oct 18, 2010, the company said. Ev3 sent a letter to all affect health facilities on Nov. 10. Healthcare provides with questions about their Ev3 products should contact their vendors.