ev3 NanoCross .014inch OTW PTA Dilatation Catheter: Class I Recall - Potential for cracking or breaking
MedSun: Newsletter #56, January 2011

FDA MedWatch Safety Alert

There is potential for cracking or breaking during use. Cracking or breaking of the catheter shaft can result in the inability to inflate or deflate the balloon, and can result in separation of catheter components and potential embolization catheter fragments. Ev3 notified healthcare facilities of the issue with the NanoCross .014” OTW PTA Dilatation Catheter and requested that all affected products are located and removed from use.

Additional Information:

FDA MedWatch Safety Alert. ev3 NanoCross .014" OTW PTA Dilatation Catheter: Class I Recall - Potential for cracking or breaking. December 28, 2010.
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm238291.htm


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