Cook Medical, Inc Zilver PTX Drug-Eluting Peripheral Stent: Class 1 Recall – Complaints of Delivery System Tip Separation

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 delivery 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.  This recall includes all sizes, diameters and lot numbers prior to April 16, 2013.

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