MINNEAPOLIS--(BUSINESS WIRE)--Medtronic, Inc. (NYSE: MDT) announced that the U.S. Food and Drug Administration (FDA) classified as Class I its voluntary recall action initiated on February 11, 2009 of its BioGlide® Ventricular Snap Shunt Catheter (Cat. #s 27782, 27708 and 27802) – the cerebral ventricular catheter component of a shunt for the treatment of hydrocephalus. FDA defines Class I recalls as, “a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.” This recall action (applicable to units in the United States, Ireland and Australia) involved the retrieval of unused product and safety notification of implanted product of these three catalog numbers of Medtronic Cerebral Ventricular Catheters. Approximately 3,000 catheters have been distributed between 2002 and 2009. It is estimated that there are 300 unused catheters.
