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Medtronic and FDA notified healthcare professionals about a Class I recall of the Innervision Snap Shunt Ventricular Catheter, BioGlide and Snap Shunt Ventricular Catheter, BioGlide due to 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 December 12, 2008. Patients with questions are encouraged to talk with their physicians. Medtronic sent their customers a recall notice on February 13, 2009 informing them 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.
Read the MedWatch safety summary, including a link to the recall notice, at:
http://www.fda.gov/medwatch/safety/2009/safety09.htm#Innervision
You are encouraged to report all serious adverse events and product quality problems to FDA MedWatch at www.fda.gov/medwatch/report.htm
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GovDelivery, Inc. sending on behalf of U.S. Food & Drug Administration (FDA) · 5600 Fishers Lane · Rockville MD 20857 · 800-439-1420
GovDelivery, Inc. sending on behalf of U.S. Food & Drug Administration (FDA) · 5600 Fishers Lane · Rockville MD 20857 · 800-439-1420
