Potential for Delivery System Catheter Separation Prompts Cook Medical To Initiate Voluntary Global Recall of Zilver® PTX® Drug Eluting Stent

Limerick, Ireland — April 24, 2013 — Based on its investigation into a small number of complaints that the delivery system of the device had separated at the tip of the inner catheter, Cook Medical has initiated a nationwide/global voluntary recall of its Zilver® PTX® Drug Eluting Peripheral Stent. Cook received 13 complaints of delivery system tip separation with an occurrence rate of 0.043 percent. Two adverse events, including one death, occurred in cases where a tip separation was reported.