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CSI Says ViperSheath Sheath Introducer Could Break, Recall Issued

Nov 18, 2009 | Parker Waichman LLP

Cardiovascular Systems Inc (CSI) has initiated a recall of all lots of the ViperSheath Sheath Introducer on behalf of Thomas Medical.  According to the recall notice, Thomas Medical has received reports of fracturing or stretching occurring when the ViperSheath Sheath Introducer is in use.

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

It In the event of a device fracture, separated segments of the ViperSheath Sheath Introducer 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 ViperSheath Sheath Introducer encountered the issues related to this recall. No permanent patient injuries have been reported. In these instances, successful surgical interventions were performed to retrieve a portion of the sheath

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

CSI has notified all customers by FedEx about the recall and is arranging for the return of all products. Customers with questions may contact CSI at 1-877-274-0360.

The ViperSheath Sheath Introducer recall was first announced on November 2, and CSI's recall notice was posted on the Food & Drug Administration's Web site yesterday.

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