Recall Z-1228-2014— Thoratec Corporation
Class I · Terminated
Class I FDA medical device recall by Thoratec Corporation, initiated 2014-03-04, terminated 2015-08-27. FDA's recall record names no specific 510(k) clearance for this event. Product: HeartMate II System Controller Product Usage: HeartMate II is a mechanical device that circulates blood throughout the body when the heart is too weak to pump blood adequately on its own. It is sometimes called a a heart pump or VAD. HeartMate II is a small implantable LVAD. HeartMate II attaches to the heart and is designed to assist or take over the pumping function of the patients left ventricle, the main pumping chamber of the heart.. Reason: Discovery of serious injuries and deaths associated with the process of changing from a primary System controller to their back-up System controller in patients using the Pocket System controller model..
- Recalling firm
- Thoratec Corporation
- Classification
- Class I
- Status
- Terminated
- Initiated
- 2014-03-04
- Terminated
- 2015-08-27
- Firm location
- Pleasanton, CA, United States
Product description
HeartMate II System Controller Product Usage: HeartMate II is a mechanical device that circulates blood throughout the body when the heart is too weak to pump blood adequately on its own. It is sometimes called a a heart pump or VAD. HeartMate II is a small implantable LVAD. HeartMate II attaches to the heart and is designed to assist or take over the pumping function of the patients left ventricle, the main pumping chamber of the heart.
Reason for recall
Discovery of serious injuries and deaths associated with the process of changing from a primary System controller to their back-up System controller in patients using the Pocket System controller model.
Data sourced from openFDA. This site is unofficial and independent of the FDA.