![[ Beasley Allen Law Firm Logo ]](http://www.southerninjurylawyer.com/wp-content/themes/system-unity/images/logo.png){kind=logo}
Medical product recalled due to patient injuries
November 4th, 2009 by Jennifer Walker-Journey
A sheath used to deliver therapeutic or diagnostic intravascular devices or fluids through the skin is being recalled by the distributor as a result of complaints about stretching or fracture of the sheath during use which have lead to patient injury, according to an announcement by the Food and Drug Administration (FDA).
The nationwide recall includes all lots of the CROSSOVER Sheath Introducer, a product developed and manufactured by Thomas Medical Products, Inc., and distributed by Cordis. It is a long-coil reinforced, kink-resistant catheter sheath intended for use in arterial and venous procedures requiring the percutaneous, or through the skin, introduction of therapeutic or diagnostic intravascular devices or fluids.
When the device fractures, separated segments of the device can emobolize downstream in the bloodstream and impede blood flow distal to the point where the segments lodge. This can result in ischemia or infarct to the distal extremity. Because the device is coil reinforced, there is a risk of the coil creating the potential for vessel dissection or perforation.
To date, Cordis has received six complaints about the CROSSOVER Sheath Introducer. Two cases required surgical intervention to retrieve a portion of the sheath. Both were performed successfully. No permanent patient injuries have been reported.
The recall includes products distributed between August 14, 2009 and September 23, 2009 and includes lot numbers U0000025 through U0000059 and Catalog numbers: 403545S, 403585S, 403645S, 403685S, 403745S, 403785S.
Cordis has notified all customers by FedEx about the recall and is arranging for the return of all products. Customers with questions may contact Cordis at 1-800-327-7714, 24 hours a day, 7 days a week.
