The FDA has issued a Class I recall for the Cook Medical, Inc., Zilver PTX Drug-Eluting Peripheral Stent. All sizes, diameters and lot numbers manufactured prior to April 16 2013 are implicated.
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.
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. Hence the issuance of the FDA’s highest category of recall notice.
Cook Medical sent an Urgent Medical Device Recall letter to all affected customers back in April . The letter identified the affected products, description of the problem, and actions to be taken. The letter instructed customers to stop using the device and quarantine and return all affected products.
Bare metal versions of Cook’s Medical Zilver Flex use a different delivery system and is not included in this recall.