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A medical device recall has been issued for the Thoratec Corporation HeartMate II LVAS Pocket System Controller for insufficient labeling and training for patients switched from the EPC Controller. Thoratec has received five reports of serious injury and four reports of death associated with difficulty in changing from the primary system controller to a back-up system controller. All reports were linked to patients whose HeartMate II LVAS device was originally attached to an older model of controller, the EPC System controller. When the Pocket System Controller became available, patients were switched from the EPC System Controller to the Pocket System Controller. However, these patients did not receive intensive training on connecting the new controller. The design differences between the EPC System Controller and the Pocket System Controller require a different approach to how the device is connected. If the controller is not properly connected, the device cannot function. For more information, please see http://www.fda.gov/MedicalDevices/Safety/ListofRecalls/ucm391322.htm
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