Cook Medical: Trouble Ahead Following Zilver PTX Stent Recall

Cook Medical (Bloomington, IN) may face dire financial ramifications over a recall of its Zilver PTX stent. While the company hasn't released numbers on the impact of the Class I recall, the device has been used in over 30,000 patients around the world since its approval in 2009.

With each stent generating $2,750 in the United States for the company, the recall could prove costly to Cook Medical. The Zilver PTX first landed FDA approval in November of last year. According to the Millenium Research Group, the company may sell as many as 40,000 units annually. This represents $110 million in annual revenue that could come under fire.

The Zilver PTX Class I recall doesn't impact devices that are already implanted in patients. However, devices sold between December 13th of 2012 and April 16th of 2013 have been recalled. New Zilver PTX stents manufactured in the company's facility in Limerick, Ireland have also been recalled. The company is currently awaiting approval to send out replacement Zilver stents.

For Cook Medical, all this bad news comes with a silver lining. Last week, the company landed approval from FDA regulators for a new bile duct stent. The approval gives Cook Medical access to the 35,000 patients who suffer from obstructed bile ducts every year.

The company first landed CE Mark approval in Europe for its biliary stent one year ago. Since that time, the company has sold 1200 of the devices.