Medtronic recalls additional defibrillators
22 April 2005
Redmond,, Wash. USA. Medtronic, Inc. (NYSE:MDT) announced that it has
identified an additional 396 monophasic LIFEPAK(R) 500 automated external
defibrillators (AEDs) to be included in a voluntary recall originally
announced on Feb. 25, 2005. The company will be contacting the owners of the
additional 396 devices that are in use worldwide.
The affected AEDs may continue to display a "connect electrodes" message
and may not analyze the patient's heart rhythm even when the electrodes are
properly connected. Failure to analyze the patient's heart rhythm will
inhibit defibrillation, if it is needed.
The company has already completed the updates or upgrades to the devices
originally identified as affected. The company plans to complete the update
or upgrade to the additional affected devices by May 31, 2005. Affected AEDs
may remain in service, and customers with devices in this additional group
are currently being contacted with recommendations for use and replacement
schedules. Only certain monophasic LIFEPAK 500 AEDs manufactured in 1997 are
included in this action.
Customers with further questions about this issue should call
1-877-873-7630 or visit
www.medtronic-ers.com/500 to determine if their device is included in
The U.S. Food and Drug Administration (FDA) was apprised of the
additional devices the week of April 18, 2005. FDA classified the original
action February 24, 2005 as a Class I recall. The FDA defines Class I as a
situation in which there is reasonable probability that the use of or
exposure to the product will cause serious adverse health consequences or
The LIFEPAK 500 is used by first responders such as firefighters, police
and others trained in CPR/AED use and are first to arrive at the scene of a
cardiac incident but do not have significant medical training.