Medtronic, FDA Announce Catheter Recalls
March 30, 2009 – Medtronic and the FDA announced a Class I recall of the Innervision Snap Shunt Ventricular Catheter, BioGlide and Snap Shunt Ventricular Catheter, BioGlide.
The recalls are based on the possibility that the ventricular catheter may become detached from the snap base assembly after implantation and may require emergency corrective surgery. The ventricular catheters are part of a surgically implanted system that redirects excess fluid from the brain to another part of the body.
The recalled product was distributed from April 29, 2004 through Dec. 12, 2008. Patients with questions are encouraged to talk with their physicians. Medtronic customers were contacted with the recall notice on Feb. 13, 2009. The notice informed customers that they should stop using the device, are required to account for each used (implanted) device, are to advise surgeons about the recall and need to return all unused products to the company.
For more information: http://www.fda.gov/medwatch/safety/2009/safety09.htm#Innervision