On November 16, 2009, Cardiovascular Systems, Inc. (CSI) (Nasdaq: CSII) announced a recall of all lots of the ViperSheath Sheath 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.

 

Click here to review the FDA Recall Notice.

 

The Recall Notice states that the recall was initiated 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.

 

If you believe that you have been injured by a defective ViperSheath Introducer, contact the Kosieradzki • Smith Law Firm online or call our firm at (763) 746-7800, or toll-free at (888) 545-7640, for a free no-obligation consultation. You can count on and trust the Kosieradzki • Smith Law Firm’s experience, commitment and resources to ensure that your rights are protected.