Medtronic Recalls BioGlide Ventricular Shunt CathetersMar 30, 2009 | Parker Waichman LLP
A class I recall has been issued for Medtronic BioGlide Ventricular Shunt Catheters. A class I recall is issued when a device poses a risk of serious injury and death.
The recalled Medtronic BioGlide Ventricular Shunt Catheter is part of a system used to treat a condition called hydrocephalus, which is characterized by an excessive accumulation of fluid in the brain. While hydrocephalus occurs in adults, it is most common in children.
According to the recall notice, the defective BioGlide Ventricular Shunt Catheters were recalled because a piece can dislodge from the snap base assembly after implantation and remain in the skull. This can result in additional, corrective surgery. Medtronic has received nine reports of such an occurrence.
The recall involves the following models:
- Innervision Snap Shunt Ventricular Catheter, BioGlide Catalog Number 27782
- Snap Shunt Ventricular Catheter, BioGlide Catalog Number 27802
- Snap Shunt Ventricular Catheter, BioGlide Catalog Number 27708
The recalled Medtronic BioGlide Ventricular Shunt Catheters were manufactured from October, 2002 through December, 2008 and distributed from April 29, 2004 through December 12, 2008. They were sold in the U.S., Australia and Asia.
In February, Medtronic sent their customers a recall notice informing them that they:
- should stop using the device,
- need to return all unused products to the company,
- are required to account for each used (implanted) device, and
- are to advise surgeons about the recall.
According to the company, approximately 3000 catheters were distributed between 2002 and 2009, and approximately 300 catheters were unused.
If a disconnection occurs, patients may present with a return of the symptoms of hydrocephalus. Symptoms of a shunt catheter malfunction include nausea, vomiting, headache, lethargy, a change in "mental status," seizures and visual disturbances.
Patients with the implanted shunt system not experiencing symptoms of shunt malfunction should continue to be managed under the standard patient management protocols, Medtronic said.
Patients with questions about the Medtronic BioGlide Ventricular Shunt Catheter recall are encouraged to talk with their physician or contact Medtronic Neurosurgery at 1-805-571-8400, Monday – Friday, 8 a.m. to 5 p.m. CDT.