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FDA Issues Recall for Zilver PTX DES
The Zilver PTX drug-eluting peripheral stent has received a Class I recall from the FDA after a small number of complaints were received concerning the stent’s delivery system separating at the tip of the inner catheter.
The recall includes all sizes, diameters and lot numbers of the Zilver PTX stent (Cook Medical) prior to April 16, 2013. The recall does not include bare-metal versions of the Zilver Flex, which use a different delivery system.
Potential adverse events that may occur in cases of breakage of the inner catheter, according to a release issued by the FDA, include possible surgery to remove the catheter tip, vascular occlusion due to an unretrieved catheter tip, thrombosis, amputation, possible cardiac arrest and death.
On April 24th, Cook Medical sent an urgent medical device recall letter to all affected customers, which detailed the affected products, description of the problem and actions to be taken. The letter instructed customers to stop using the device; quarantine and return all affected products; and complete the product reply form and return the affected products for credit to Cook Medical.
For more information on this recall, the FDA press release can be viewed here.