CSI Recalls Sheath Introducers Amid Breakage Fears

Law360, New York (November 17, 2009, 6:07 PM EST) -- St. Paul, Minn.-based Cardiovascular Systems Inc. has announced a voluntary recall of all lots of its ViperSheath catheter sheath introducers amid concerns that the sheaths may stretch or fracture during use.

The U.S. Food and Drug Administration published Cardiovascular Systems' notice regarding the voluntary recall on its Web site Monday, noting that the company had initiated the nationwide recall Nov. 2.

The ViperSheath line is developed and manufactured by Indianapolis-based Thomas Medical Products Inc. and distributed by Cardiovascular Systems, according to the news release. It is...
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