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Medtronic Recalls Shunt Catheters

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Medtronic Inc. is recalling  its  BioGlide Ventricular Shunt Catheters.  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 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. 

The Food & Drug Administration has deemed the action a class I recall.  A class I recall is issued when a device poses a risk of serious injury and death.

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

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.

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. According to the company, approximately 3000 catheters were distributed between 2002 and 2009, and approximately 300 catheters were unused.

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