A device made by Medtronic Inc. to drain excess fluid in the brain, primarily in children, has been recalled by the Food and Drug Administration (FDA) because a piece can dislodge and remain in the skull. No deaths or serious injuries have been reported.
The Fridley-based medical technology company said there have been nine reports of the tip of its BioGlide Ventricular Snap Shunt Catheter disconnecting from its implanted base, requiring revision surgery. The product is made in California.
The FDA has given the recall its most-serious status, meaning the malfunction could lead to serious injury or death.
Medtronic said about 3,000 of the catheters have been distributed between the product's launch in October 2002 and this year, with roughly 2,500 to 2,700 implanted in patients.
The first report of failure occurred in early December, and by mid-March the company said it had contacted all users of the catheter.
The device is part of a system used to treat a condition called hydrocephalus, which is characterized by an excessive accumulation of fluid in the brain that can occur in both adults and children. Experts estimate that hydrocephalus affects approximately one in every 500 children.
Patients treated with a failing device may experience nausea, vomiting, headache, lethargy, a change in "mental status," seizures and visual disturbances.
The recall involves the following models: Innervision Snap Shunt Ventricular Catheter, BioGlide, catalog number 27782; Snap Shunt Ventricular Catheter, BioGlide, catalog numbers 27802 and 27708.
