Cordis Crossover Catheter Sheath Introducer Recall Issued

A recall has been issued by Cordis Corporation for their Crossover Sheath Introducer for catheters, which has been found to stretch or fracture. This could cause fragments to enter the bloodstream and potentially cause an embolism or other life-threatening injury.

The Cordis Crossover Catheter Sheath Introducer recall affects all lots distributed between August 14, 2009 and September 23, 2009 with catalog numbers 403545S, 403585S, 403645S, 403685S, 403745S, and 403785S. The introducers were manufacturd by Thomas Medical Products, Inc. and distributed by Cordis Corporation.

The Crossover is a coil-reinforced catheter sheath which is used to thread catheter tubes into the body through a vein or artery.

At least six reports have been received of the sheath introducers failing. If the devices fracture, the fragments have the potential of entering the bloodstream and lodging inside a vein or artery, disrupting the flow of blood. There is also a possibility that the coil inside the sheath could poke through if the sheath fractures, possibly dissecting or perforating a blood vessel.

In two cases, surgery was performed in order to remove fragments of the Crossover Sheath Introducer from patients’ bodies.

Cordis says that it has contacted all customers via Federal Express and is arranging for the return of all of the recalled products. Anyone who has experienced an adverse effect due to defective Cordis Sheath Introducers should report the incident to the FDA’s MedWatch program at http://www.fda.gov/medwatch/report.htm.