Cordis recalls its CROSSOVER Sheath Introducer

Cordis CorporationOct 29 2009

Cordis Corporation announced today a nationwide voluntary recall of all lots of the CROSSOVER^™ Sheath Introducer due to complaints about stretching or fracture of the sheath during use.

The CROSSOVER^™ Sheath Introducer is 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.

In the event of a device fracture, separated segments of the device can embolize downstream in the bloodstream and impede blood flow distal to the point where it lodges, resulting in ischemia or infarct to the distal extremity. 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. The physician may be required to perform unplanned open surgery to remove the retained segments or control bleeding. If a procedure has been completed successfully using the product, there is no concern.

To date, Cordis has received six complaints about the CROSSOVER^™ Sheath Introducer. No permanent patient injuries have been reported. In two instances, successful surgical intervention was performed to retrieve a portion of the sheath.

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, seven days a week.

The recall encompasses products distributed from August 14, 2009 to September 23, 2009 and includes the following lot ranges and catalog numbers:

• Lot range: U0000025 through U0000059
• Catalog numbers: 403545S, 403585S, 403645S, 403685S, 403745S, 403785S

Cordis has apprised the U.S. Food and Drug Administration (FDA) of this action. Any adverse events experienced with the use of this product and/or quality problems should be reported the FDA’s MedWatch Program by fax at 1-800-FDA-0178, by mail at MedWatch, HF-2, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787, or on the MedWatch website at www.fda.gov/medwatch.