Company Recalls Sheath Introducer
November 18, 2009
Cardiovascular Systems (CSI) is recalling certain lots of its ViperSheath sheath introducer due to reports of the sheath stretching or fracturing during use. Developed and manufactured by Thomas Medical and distributed by CSI, the products were distributed from March 25 to Oct. 21. A device fracture may require surgery to remove segments or control bleeding. Vessel dissection or perforation could occur if portions of the device’s coil become exposed, according to an FDA statement.