Shunt Ventricular Catheters

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Class One Recall Issued for Shunt Ventricular Catheters

In February 2009, the U.S. Food & Drug Administration (FDA) issued a Class One Recall of Innervision Snap Shunt Ventricular Catheters and BioGlide and Snap Shunt Ventricular Catheters. A Class One Recall is the most serious recall the FDA can issue, it means “there is a reasonable probability that use of these products will serious injury or death.” The recall was necessary because parts of the device were malfunctioning and harming patients.

Ventricular Catheters are part of a shunt, which is a system implanted in patients during surgery. The Ventricular Catheters are designed to redirect excess fluid from the brain to other parts of the body. These shunt systems are used to treat a condition called hydrocephalus. Hydrocephalus is an accumulation of excess cerebrospinal fluid in the brain. The catheters become detached from the whole shunt device. The pieces can become lodged in the skull. Emergency surgery is necessary to correct this problem. There have been nine reports of this occurring so far.

The Ventricular Shunt Catheters are manufactured by Medtronics. Medtronics from October 2002 - December 2008, manufactured the recalled products. The catheters were distributed in the United States from April 2004 - December 2008. The devices affected by the recall are Innversion Snap Shunt Ventricular Catheter, BioGlide Catalog Number 27782, Snap Shunt Ventricular Catheter, BioGlide Catalog Number 27802 and Snap Shunt Ventricular Catheter, BioGlide Catalog Number 27708.

If a disconnection of the device occurs, patients often experience many symptoms. Such symptoms include nausea, vomiting, headache, lethargy, seizures, visual disturbances and “changes” in mental status. If any of these symptoms are observed, patients should be aware they might have a shunt catheter malfunction. Patients may also experience symptoms showing a return of hydrocephalus.

A recall notice has been sent to users of Medtronic’s catheters. Patients should immediately stop using the device and talk to surgeons about their recall. If you believe that you or a loved one has suffered because of Ventricular Shunt Catheters, you may want to speak with an attorney regarding a potential lawsuit. Please CLICK HERE for a free consultation.