Brain Shunt Device Recalled by FDA

Device May Leak Cerebrospinal Fluid Resulting in Adverse Health Effects

The FDA has issued a Class I recall of the Gravity Compensating Accessory (GCA), High Pressure Range, Sterile, Single Use, Prescription Use (Rx) only. The device is 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.

The GCA is being recalled because it 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. This product was manufactured in January, 2008 through May, 2008 and distributed from February 22, 2008 through June 1, 2008.

The manufacturer, Integra NeuroSciences, 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.

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Published on Dec-11-08