The FDA has issued a Class I recall of Zilver PTX Drug-Eluting Peripheral Stent.
Bloomington, Ind.-based Cook Medical initiated a voluntary recall of the stent on April 24 after the company received complaints about delivery system tip separation. Two adverse events, including one death, occurred in cases where a tip separation was reported.
Class I recalls are the most serious type of recall and involve situations in which there is a reasonable probability that use of the products will cause serious adverse health consequences or death. Potential adverse events related to the of Zilver PTX Drug-Eluting Peripheral Stent include possible surgery to remove the catheter tip; vascular occlusion due to an unretrieved catheter tip; thrombosis; amputation; and possible cardiac arrest.
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. The recall includes all sizes, diameters and lot numbers prior to April 16, 2013. Those with the device should stop using it, quarantine any inventory and return it for credit.
Bare metal versions of Zilver Flex use a different delivery system and are not included in this recall.