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U.S. Department of Health and Human Services

Medical Devices

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Integra NeuroSciences, Gravity Compensating Accessory

Class 1 Recall
Date Recall
Initiated:
October 3, 2008
Product:

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.

 

Use:

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.

 

Recalling Firm:

Integra NeuroSciences
311 Enterprise Drive
Plainsboro, New Jersey 08536

 

Reason for Recall:

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.

 

Public Contact:
The company may be contacted at 1-609-275-0500.
FDA District:

New Jersey

 

FDA Comment:

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.  See nearby link to MedWatch.