Medical device recalled due to risk of blood vessel perforation

A sheath designed to facilitate the entry of an intravascular device through the skin is being recalled by the Food and Drug Administration (FDA) because the device may be fractured, which may require unplanned open surgery to remove the retained segments or control bleeding. The recall includes all lots of the ViperSheath Sheath Introducer made by Thomas Medical and distributed by Cardiovascular Systems, Inc. (CSI).

The ViperSheath Inducer is a long-coil reinforced, kink-resistant catheter sheath. Thomas Medical initiated the recall 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. 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 includes 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

To date, CSI is aware of three instances where a ViperSheath Sheath Introducer encountered the issues related to this product. No permanent patient injuries have been reported. In these instances, 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.

Source: FDA