The FDA and Cardiovascular Systems have issued 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 to control bleeding. Since this device is coil reinforced, any separation of the cannula has the potential to expose portions of the coil, creating the potential for vessel dissection or perforation.
Cardiovascular Systems said it has been made aware of three instances where a ViperSheath encountered the issues related to this recall, and no permanent patient injuries have been reported. In these instances, surgical interventions were performed to retrieve a portion of the sheath.
The recall encompasses products distributed from March 25 to Oct. 21, and including the following:
- Lot range: S28117 through S29174; and
- 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 and VPR-ISH 7 X 45.
The St. Paul, Minn.-based company said it does not expect the voluntary recall to have a material effect on its financial results, as the "product accounts for less than one percent of [its] current revenue."