HeartMate II LVAS Pocket System Controller by Thoratec Corporation: Medical Device Correction
MedSun: Newsletter #93, March 2014

FDA MedWatch Safety Alert

Thoratec Corporation issued a safety advisory because some patients and caregivers have experienced difficulties with the process of changing from a primary system controller to their backup system controller. Consumers who have the HeartMate II LVAS Pocket Controller should immediately contact their doctor for retraining on use of the device and to receive updated patient handbook information. Physicians who prescribe the HeartMate II LVAS Pocket Controller should immediately review the updated labeling and training materials with all clinical personnel responsible for training patients and caregivers on the use of the Pocket System Controller.

Additional Information:

HeartMate II LVAS Pocket System Controller by Thoratec Corporation: Medical Device Correction. FDA MedWatch Safety Alert. March 5, 2014
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm388059.htm


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