Cook Medical Initiates Voluntary Recall of Zilver PTX Due to Potential for Delivery System Catheter Separation

April 24, 2013—Cook Medical (Bloomington, IN) announced that the company has initiated a nationwide/global voluntary recall of its Zilver PTX drug-eluting peripheral stent. The recall is based on its investigation into a small number of complaints that the device's delivery system had separated at the tip of the inner catheter. The company advised that it received 13 complaints of delivery system tip separation with an occurrence rate of 0.043%. Two adverse events, including one death, occurred in cases in which a tip separation was reported.

According to Cook's announcement, potential adverse events that may occur in cases in which inner delivery catheter breakage occurs include: possible surgery to remove the catheter tip; vascular occlusion due to an unretrieved catheter tip; thrombosis; amputation; and possible cardiac arrest.

These devices were distributed to medical institutions in the United States between December 13, 2012 and April 16, 2013. Cook has initiated a voluntary global recall of all sizes, diameters, and lot numbers (Catalog number ZIV6*****PTX). Consignees should stop using the device, quarantine any inventory, and return it for credit, stated the company.

The US Food and Drug Administration (FDA) has been made aware of this recall. The company stated that any adverse events should be reported to Cook Medical Customer Relations at (800) 457-4500 or (812) 339-2235, Monday through Friday between 7:30 am and 5:00 pm Eastern Time, or via email at CustomerrelationsNA@cookmedical.com. 

Adverse events or quality problems experienced with the use of this product may also be reported to the FDA online at http://www.fda.gov/Safety/MedWatch/HowToReport/default.htm, where there is a form available to fax or mail, or by phone at FDA (800) FDA-1088.

The recall is specific to the delivery system, not the stent itself, noted Rob Lyles, Vice President and Global Leader of Cook Medical’s Peripheral Interventional clinical division, in the press release. If a patient has had a Zilver PTX stent implanted and the delivery system was removed safely and intact, that patient is at no risk and is not affected by this recall. Bare-metal versions of Cook Medical’s Zilver Flex stent use a different delivery system that is not included in this recall.

Mr. Lyles stated, “We initiated a voluntary global recall because while the occurrence of the component separation was very low, we felt the risk to patients required us to act with an abundance of caution.”

In the press release, the company stated that its investigation identified an internal component of the delivery system used to implant the stent that did not consistently meet established design criteria. Cook advised that it has conducted an exhaustive quality assessment and audit of the affected components to ensure satisfactory performance of the delivery system in the future.

In the United States, the device received FDA premarket application approval in November 2012. It received CE Mark clearance in August 2009 and is approved for sale in 54 countries including Japan, Australia, and Brazil. The device is manufactured at Cook’s facility in Limerick, Ireland.