Peripheral Balloon Catheters Recalled Due to Shaft Cracks

 

January 3, 2011

January 3, 2011 – ev3, a Covidien company, has initiated a voluntary recall of specific lots of the NanoCross .014-inch Over-the-wire (OTW) peripheral transcatheter angioplasty (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 NanoCross 0.014” OTW PTA Dilatation Catheter is intended to dilate stenoses in the iliac, femoral, iliofemoral, popliteal, infra-popliteal, and renal arteries. It is also used for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. The company said catheter failure may lead to unplanned intravascular or open surgery, significant vasospasm, prolonged tissue ischemia, injury, infarct, bleeding and/or death.

In a letter dated Nov. 10, 2010, ev3 notified healthcare facilities of the NanoCross .014 OTW PTA dilatation catheters voluntary recall. In this letter, it was requested that all affected products are located and removed from use. Detailed steps were also provided about the return and disposition of these affected products to ev3.

Class I recalls are the most serious type of recall and involve situations in which there is a reasonable probability that use of these products will cause serious adverse health consequences or death.

Questions should be directed to ev3 at 763.398.7000.

For more information: www.fda.gov/Safety/Recalls/ucm238306.htm

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