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U.S. Department of Health and Human Services

Safety

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Gravity Compensating Accessory, High Pressure Range, Sterile, Single Use, by Integra NeuroSciences

Audience: Hospital surgical and neurological healthcare professionals

[Posted 12/11/2008] Integra NeuroSciences and FDA notified healthcare professionals of a recall of the Gravity Compensating Accessory (GCA), manufactured in January, 2008 through May, 2008 and distributed from February 22, 2008, through June 1, 2008. The GCA is part of a 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. The recalled 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. Patients should contact their healthcare professional with any questions or concerns.

[December 11, 2008 - Recall Notice - FDA]