Medtronic Ventricular Catheter Recall: May Detach After Shunt Implanted

Medtronic Neurologic Technologies and the FDA announced a Class I recall on March 27, 2009, for Snap Shunt Ventricular Catheters distributed between April 2004 and December 2008, as the snap base assembly may detach after surgical implantation of the shunt. This could cause potentially serious injury and expose the patient to a risky emergency surgery to correct the problem.

The Medtronic ventricular catheter recall applies to all versions and all lot numbers of the “Innervision Snap Shunt Ventriular Catheter, BioGlide” and “Snap Shunt Ventricular Catheter, BioGlide”, with catalog numbers 27782, 27708 and 27802.

Ventricular catheters are part of a shunt system that is implanted surgically for the redirection of excess cerebrospinal fluid from the lateral ventricles of the brain to a different part of the body, such as the abdomen. Shunts are used to treat hydrocephalus, a condition where excess cerebrospinal fluid accumulates in the brain.

Medical providers have been urged to stop using the Medtronic catheter. The action was classified as a “Class I” recall, which is the most serious type of recall, involving situations where there is a reasonable probability that the use of the product will cause serious injury or death.

Medtronic sent notice to their customers of the Snap Shunt Ventricular Catheter recall on February 13, 2009, and requested that they inform surgeons about the recall and to return all unused devices to the company.