
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.