MINNEAPOLIS--(BUSINESS WIRE)--Physio-Control, Inc., a wholly-owned subsidiary of Medtronic, Inc., (NYSE: MDT), announced today the U.S. Food and Drug Administration (FDA) has classified the company’s decision to perform a voluntary correction of LIFEPAK 15 monitor/defibrillators manufactured prior to December 16, 2009 as a Class I recall. Analysis conducted by Physio-Control verified the affected devices were manufactured with an internal component that could cause an electrical short that leads to the device turning off/on by itself or a power loss. A loss of power could delay or prevent delivery of defibrillation therapy. There have been no adverse patient events related to this potential issue.
