Cook Medical says its Zilver PTX peripheral stent, which it recalled back in April, is back on the market worldwide.
Three months after the recall of its Zilver PTX peripheral stent, Cook Medical has the device back on the market across the globe.
Rob Lyles, vice president and global leader of Cook’s peripheral intervention business, told MassDevice.com today that the FDA cleared the device to go back on the U.S. market July 25.
"We had already received similar clearances in Europe and Japan," Lyles told us, noting that Australia also OK'd the return to market July 25. "We had received regulatory clearance globally in all the major markets as of the 25th, so late last week we began shipping product back out."