Class 1 Recall: Integra NeuroSciences, Gravity Compensating Accessory

Gravity Compensating Accessory, High Pressure Range, Sterile, Single Use, Prescription Use (Rx) only

This product was manufactured in January, 2008 through May, 2008 and distributed from February 22, 2008 through June 1, 2008.

The Gravity Compensating Accessory (GCA) is a part of the system that redirects (shunts) excess fluid from the brain to the abdomen. The GCA prevents too much fluid from being redirected from the brain while sitting or standing.

These devices may leak cerebrospinal fluid which may cause inflammation of brain, spinal cord, or abdominal membranes, pressure on the wound created by implantation of the device, or failure of the shunt system.

The company sent their customers a recall letter on October 9, 2008. The firm also sent letters directly to doctors who may have implanted the recalled device.

Class 1 recalls are the most serious type of recall and involve situations in which there is a reasonable probability that use of these products will cause serious injury or death.

Health care professionals and consumers may report adverse reactions or quality problems experienced with the use of these products to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by FAX.

• Online:www.fda.gov/MedWatch/report.htm
• Regular Mail: use postage-paid FDA form 3500 available at: www.fda.gov/MedWatch/getforms.htm
  Mail to MedWatch 5600 Fishers Lane, Rockville, MD 20852-9787
• FAX: 1-800-FDA-0178