April 30, 2013 – A worldwide recall has been issued for the Cook Medical Zilver PTX Drug Eluting Peripheral Stent, the first device of its kind designed to be used in the superficial femoral artery (SFA). The recall was ordered after Cook Medical received a number of complaints about the device separating at the tip of the inner catheter. Two adverse events, including one death, occurred in patients where a tip separation was reported.
Free Cook Zilver PTX Stent Recall Lawsuit Evaluation: If you or a loved one suffered a serious injury after receiving a Cook Zilver PTX Stent included in this recall, you should contact our law firm immediately. You may be entitled to compensation by filing a suit against Cook Medical and we can help.
What’s the Problem?
According to a press release issued today by the U.S. Food & Drug Administration (FDA), potential adverse events that may result from the breakage of an inner delivery catheter include:
- possible surgery to remove the catheter tip
- vascular occlusion due to an unretrieved catheter tip
- cardiac arrest
Cook Zilver PTX Stents were distributed to medical facilities nationwide between December 13, 2012 and April 16, 2013. This recall affects all sizes, diameters and lot numbers (Catalog number ZIV6*****PTX). Institutions that received the devices should stop using them immediately, quarantine any inventory, and return it to Cook Medical for credit.
It is important to note that this recall is specific to the delivery system, not the stent itself. If a patient has had a Cook Zilver PTX Stent implanted and the delivery system was removed safely and without incident, the individual is at no risk and should disregard this recall. Bare metal versions of the Zilver Flex stent use a different delivery system, and are not affected by this action.
The problem with the stent may lie with an internal component of the delivery system which did not consistently meet established design criteria. Cook Medical has performed a quality assessment and audit of the affected components to ensure satisfactory performance in the future.
The Cook Zilver PTX Stent received FDA premarket application approval in November 2012, and received CE Mark clearance in August 2009. The device is manufactured at Cook’s facility in Limerick, Ireland, and is approved for sale in 54 countries.
“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,” said Rob Lyles, vice president and global leader of Cook Medical’s Peripheral Interventional clinical division.
Do I Have a Cook Zilver PTX Stent Recall Lawsuit?
The Medical Device Litigation Group at our law firm is an experienced team of trial lawyers that focus on the representation of plaintiffs in Cook Zilver PTX Stent recall lawsuits. We are handling individual litigation nationwide and currently accepting new Cook Zilver PTX Stent complications cases in all 50 states.
Free Cook Zilver PTX Stent Recall Lawsuit Evaluation: If you or a loved one suffered a serious injury after receiving a Cook Zilver PTX Stent included in this recall, you should contact our law firm immediately. You may be entitled to compensation by filing a Cook Zilver PTX Stent recall suit and we can help.