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U.S. Department of Health and Human Services

Safety

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Cardiovascular Systems ViperSheath Sheath Introducer - Recall

Audience: Cardiological and interventional radiological healthcare professionals, hospital risk managers

[UPDATED 12/04/2009] Recall classified as Class I. 

[Posted 11/17/2009] 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.

The recall encompasses products distributed from March 25, 2009 to October 21, 2009, and includes the following lot ranges and catalog numbers:

  • Lot range: S28117 through S29174
  • 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

[12/04/2009 - Recall Notice - FDA]
[11/16/2009 - Press Release - Cardiovascular Systems, Inc.]