FDA Announces Recall Of Defective Medical Device

by Staff Blogger | April 30th, 2013

April 30, 2013

The U.S. Food and Drug Administration (FDA) announced the voluntary recall of the Zilver® PTX® Drug Eluting Stent manufactured by Cook Medical due to malfunctions that could compromise patient safety.

The device is a expanding metal mesh tube that is coated with a medication. The device is used to keep arteries in the body from narrowing and is commonly used in the treatment of Peripheral Artery Disease. The affected devices were sold worldwide between December of 2012 and April of 2013.

The product was declared a Defective Medical Device after the FDA received reports of two serious adverse events, including one death, related to the use of the product.

According to an FDA press release, the problem is that the catheter tip can separate from the rest of the device, which can cause the catheter tip to become lodged in the artery and block blood flow. This can result in numerous health problems including thrombosis and cardiac arrest.

Those who are in possession of the affected products have been instructed to halt use of the devices immediately and to quarantine any remaining stock of the product.

Ferrer, Poirot & Wansbrough and their team of Dallas Personal Injury Attorneys recognize the risks that can be posed through the use of certain medical devices. The firm encourages anyone who has been injured through the use of a recalled product to discuss their legal rights with an attorney.