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

["U.S. Food & Drug Administration (FDA)" <fda@xxxxxxxxxxxxxxxxxxxxxxx>]

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

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

04/25/2013 11:00 AM EDT

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.

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