Cook Medical's Zilver PTX drug-eluting stent for peripheral artery disease has been recalled because of a defect in its associated delivery system, the company and the FDA said.
Initiated in late April, the recall covers all lots of the product distributed from Dec. 13, 2012, through April 16 of this year.
The firm said it had received 13 reports that the delivery system had separated at the tip of the inner catheter. Such events could result in surgery to retrieve the catheter tip, vascular blockage from unretrieved tips, thrombosis, amputation, or cardiac arrest, Cook Medical said. The FDA has designated the recall as Class I because of the serious risks.
One patient death has occurred as a result of the problem, the firm said. Another patient suffered an unspecified adverse event.
On the basis of the number of stent systems distributed, Cook Medical estimated that problem had occurred in 0.043% of placements.
The firm said the bare metal version of the stent uses a different delivery system and is not included in the recall. It also emphasized that, when paclitaxel-eluting stents were implanted and the delivery devices removed intact, patients are at no risk.
Customers who bought the paclitaxel-eluting peripheral stent during the period covered by the recall should quarantine remaining inventory and return it to the company for credit.