ViperSheath Catheter Sheath Recall

Posted on Dec 10, 2009 in Medical Products

St. Paul, Minn.-based Cardiovascular Systems, Inc. (CSI) is recalling all lots of the ViperSheath^TMSheath Introducer after reports of the devices fracturing and stretching, the U.S. Food and Drug Administration announced Monday. Developed and manufactured by Thomas Medical Products, Inc. and distributed by CSI, the catheter sheaths facilitate entry of an intravascular device through the skin. A device fracture may require unplanned open surgery to remove sheath segments or control bleeding. CSI has received three reports of ViperSheath complications related to this recall.

The devices were distributed from March to October 2009 and include lot numbers S28117 through S29174 and the following catalog numbers: VPR-ISH 5 X 85, VPR-ISH 6 X 85, VPR-ISH 7 X 85, VPR-ISH 5 X 45, VPR-ISH 6 X 45, VPR-ISH 7 X 45.

CSI has notified all customers of the recall and is arranging for the return of all products.