Federal health officials are warning patients that drug pumps recalled by Medtronic may fail to deliver drugs used to treat chronic pain, spasms and other conditions.
The Food and Drug Administration classified the action as a class-one recall Monday, meaning the defective devices could cause serious harm. The agency says the malfunction is caused by a film that forms on the battery.
Medtronic Inc., based in Minneapolis, first notified physicians of the issue in July and has since updated the pump's design.
The recall affects SynchroMed II implantable pump models 8637-20 and 8637-40, distributed between 2004 and July 2011. As with most implantable device recalls, the manufacturer is not recommending patients have the pumps removed. Instead patients should contact their doctor if they experience symptoms are hear the device alarm.