ViperSheath Introducer Recall: Reports of Stretching or Fractures of Sheath

A recall has been issued for all lots of the ViperSheath Sheath Introducer for catheters after the manufacturer received reports of the sheaths stretching or fracturing during use. A similar catheter sheath introducer recall was issued for the same reasons last month for the Cordis Crossover, as this could cause fragments to ender the bloodstream and potentially result in an embolism or other life-threatening injury.

The FDA announced the ViperSheath recall on Monday, impacting all lots distributed between March 25 and October 21, 2009. The recall comes after at least three reports of patients who required surgery to remove portions of the sheath from their bodies after it failed.

The ViperSheath is a coil-reinforced catheter sheath which is used to thread catheter tubes into the body through the skin. In addition to the risk of fragments entering the bloodstream, there is also a possibility that the coil inside the sheath could tear through the sheath if it fractures, possibly dissecting or perforating a blood vessel.

The recall includes Cardiovascular Systems, Inc.’s ViperSheath Sheath Introducers with lot numbers from 528117 through S29174, and catalog numbers PR-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.

A Cordis Crossover Sheath Introducer recall was issued on October 26, for the same reasons. Both the Crossover and ViperSheath introducers were manufactured by Thomas Medical Products, Inc.

Cardiovascular Systems says it has notified all of its customers by mail and is arranging for the return of all of the recalled products. Anyone who experiences a problem with the ViperSheath Sheath Introducers or Cordis Crossover Sheath Introducer should contact the FDA’s MedWatch adverse event reporting program at www.fda.gov/medwatch.