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Friday, May 31, 2013
FDA Issues Class I Recall of Zilver® PTX® Drug-Eluting Stent
The Zilver PTX Drug-Eluting Peripheral Stent was manufactured from Dec. 1, 2012 through April 16, 2013 and distributed from Dec. 13, 2012 through April 16, 2013.
Use: The Zilver PTX Drug-Eluting Peripheral Stent is a self-expanding, small metal, mesh tube with the outer surface coated with the drug Paclitaxel that is implanted in an artery of the thigh. The Paclitaxel coating helps prevents the artery from narrowing again. The Zilver PTX Drug-Eluting Peripheral Stent acts as a scaffold to hold open a narrowed artery caused by Peripheral Artery Disease in the legs and to improve blood flow.
Recalling Firm: Cook Medical, Inc. 750 N Daniels Way Bloomington, Indiana 47404-9102
Reason for Recall: Cook Medical received a small number of complaints that the delivery system of the device had separated at the tip of the inner catheter. Potential adverse events that may occur in cases where the inner deliver catheter breakage occurs include possible surgery to remove the catheter tip, vascular occlusion due to an unretrieved catheter tip, thrombosis, amputation, possible cardiac arrest, and death.