Thoratec Corporation has issued a voluntary worldwide recall of its HeartMate II LVAS Pocket System Controller in order to update its labeling and training materials. Thoratec received five reports of serious injury and four reports of death because some patients and caregivers had difficulty with the process of 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.
FDA has given the recall the most serious classification --Class I -- because use of this product may cause serious adverse health consequences, including death. 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. No product needs to be returned.
[1] FDA, "Thoratec Corporation, HeartMate II LVAS Pocket System Controller - Insufficient Labeling and Training for Patients Switched from the EPC Controller," March 4, 2014.
FDA has given the recall the most serious classification --Class I -- because use of this product may cause serious adverse health consequences, including death. 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. No product needs to be returned.
[1] FDA, "Thoratec Corporation, HeartMate II LVAS Pocket System Controller - Insufficient Labeling and Training for Patients Switched from the EPC Controller," March 4, 2014.
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