All lots of the ViperSheath Sheath Introducer have been recalled because of a breakage risk. According to Cardiovascular Systems Inc.’s (CSI) recall notice, there have been three reports of fracturing or stretching occurring when the ViperSheath Sheath Introducer is in use.
The device was developed and manufactured by Thomas Medical Products, Inc., and distributed by CSI. 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 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
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.
No permanent patient injuries have been reported. In the instances where the device has fractured, successful surgical interventions were performed to retrieve a portion of the sheath
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.
