FDA Announces Thoratec Voluntary Device Correction Letter
The U.S. Food and Drug Administration (FDA) on Sept. 14 announced that a voluntary device correction letter was sent from Thoratec Corporation concerning the HeartMate II LVAS. The letter reminds hospitals to “monitor the expiration date of the backup battery contained within the HeartMate II ‘Pocket’ System Controller”. According to Thoratec Corporation, the backup battery has a 36 month expiration date. If the expiration date passes, an advisory alarm will sound, but the HeartMate II LVAS will continue to function normally.
Keywords: Heart-Assist Devices, Hospitals, Monitoring, Physiologic, United States Food and Drug Administration
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