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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.
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