MINNEAPOLIS--(BUSINESS WIRE)--Medtronic, Inc. (NYSE: MDT) today announced that the U.S. Food and Drug Administration (FDA) has classified its communication to physicians related to inflammatory mass formation associated with intrathecal drug delivery as a Class I Recall. On January 16, 2008, Medtronic sent a letter to inform clinicians worldwide of an increase in the rate of reported inflammatory mass cases in patients who have received intrathecal drug delivery through its implantable infusion systems. This letter was an update to two previous communications on this topic that Medtronic issued in 2001 and 2003. The classification from the FDA does not change the recommendations made to physicians in the January 2008 letter and there is no new action required of physicians or patients.
