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The U.S. Food and Drug Administration has alerted health care providers to an ongoing recall launched by Abiomed Inc for a device that supplies power to a blood pump used on failing hearts.
This week the FDA notified health care providers that it has labeled this action a Class I recall, which means the defect in the device could cause serious injury or death.
The Danvers-based company began warning customers in December of a potential defect in some AB5000 circulatory support systems that could cause the computer in the device to shut down the blood pump without any alarm. The company followed this up with a letter dated Jan. 27, that was delivered when company representatives repaired the devices.
The AB5000 circulatory support systems, used in a hospital setting, supplies power to disposable blood pumps used to support the left and/or right sides of the heart.
The affected devices were manufactured between May 2003 and December 2009.
Company officials declined to comment on the recall.
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