Brain Shunt Recall: Gravity Compensating Accessory

The FDA posted a notice yesterday about a Class 1 recall issued by Integra NeuroSciences for their Gravity Compensating Accessory (High Pressure Range), part of a brain shunt system used to prevent too much fluid from being redirected from the brain to the abdomen while sitting or standing.

The device is being recalled because it may leak cerebrospinal fluid, which could cause inflammation of the spinal cord, brain or abdominal membranes, failure of the shunt system or exert pressure on the wound created by implantation of the device.

 
The product is marketed as the “Gravity Compensating Accessory (GCA), High Pressure Range, Sterile, Single Use, Prescription Use (Rx) only”. The recalled devices were distributed between February 22, 2008 through June 1, 2008.

A brain shunt is a hole or passage which redirects fluid from the brain to the abdomen, and the Gravity Compensating Accessory (GCA) is designed to counterbalance the effect of gravity within the shunt system. It prevents the sudden loss of too much cerebrospinal fluid from the central nervous system when an individual stands or sits.

The Gravity Compensating Accessory comes in three ranges of pressure or flow resistance, low, medium and high. It consists of stainless steel balls that change flow resistance through a ball and cone mechanism.

The FDA posted notice of the brain shunt device recall on their MedWatch page on December 11, 2008, notifying hospital surgical and neurological healthcare professions about the problems with the product.

The recall was first initiated by Integra NeuroSciences on October 3, 2008 and the company has sent letters directly to hospitals and other customers to directly notify doctors who may have implanted the device.

The brain shunt accessory recall was classified as a Class 1 recall, which indicates that use of the product poses a reasonable probability of serious injury or death.