Integra NeuroSciences is recalling Gravity Compensating Accessories used with brain shunting systems. According to the Food & Drug Administration (FDA) notice, the Gravity Compensating Accessory recall is a Class I recall – the agency’s most serious type.
A shunt is a tube that is placed in one of the fluid-filled chambers inside the brain. When infection or disease causes an excess of cerebrospinal fluid in the ventricles, the shunt is placed to drain the excess fluid to the abdomen. When working properly, the Gravity Compensating Accessory prevents fluid from being redirected from the brain while sitting or standing
The recall involves the Gravity Compensating Accessory, High Pressure Range, Sterile, Single Use, Prescription Use (Rx) only. The device was manufactured in January, 2008 through May, 2008 and distributed from February 22, 2008 through June 1, 2008.
The Integra Neurosciences Gravity Compensating Accessory recall was initiated on October 9, 2008. At that time, Integra Neurosciences informed its customers of the recall via a letter. The firm also sent letters directly to doctors who may have implanted the recalled device.
According to the FDA, the Integra NeuroSciences Gravity Compensating Accessory is being recalled because it may leak cerebrospinal fluid. According to the recall notice, this 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.
A Class I recall indicates that a device poses a reasonable probability of serious injury or death.
Patients and practitioners seeking more information on the Integra Neurosciences Gravity Compensating Accessory recall may contact the company at 1-609-275-0500. Health care professionals and consumers may report adverse reactions or quality problems experienced with the use of this device to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail or by FAX.
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