Cardiovascular Systems Initiates Recall of ViperSheath

Washington, DC: Cardiovascular Systems, Inc (CSI), has announced a recall of all lots of the ViperSheathTMSheath Introducer on behalf of Thomas Medical due to reports about stretching or fracture of the sheath during use. CSI initiated the nationwide recall on November 2, 2009.

The ViperSheathTM Sheath Introducer is a product developed and manufactured by Thomas Medical Products, Inc., and distributed by CSI. It is a long-coil reinforced, kink-resistant catheter sheath that facilitates percutaneous, or through the skin, entry of an intravascular device.

Thomas Medical initiated this recall due to the possibility of fractures in the device. In the event of a device fracture, separated segments of the device may require unplanned open surgery to remove the retained segments or control bleeding. Since this device is coil reinforced, any separation of the cannula (a flexible tube inserted into the body) has the potential to expose portions of the coil, creating the potential for vessel dissection or perforation.

To date, CSI is aware of three instances where a ViperSheathTM Sheath Introducer encountered the issues related to this recall. No permanent patient injuries have been reported.

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Published on Nov-17-09