Cardiovascular Systems ViperSheath Sheath Introducer - Recall
MedSun: Newsletter #43, December 2009

FDA MedWatch Safety Alert

Cardiovascular Systems, Inc. and FDA notified healthcare professionals of a nationwide 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. 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.

Additional Information:

FDA MedWatch Safety Alert. Cardiovascular Systems ViperSheath Sheath Introducer – Recall. November 16, 2009.
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm190967.htm


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