Recall Z-229-2014— 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 LVAD Pump and Pock Controller Kit; 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.. 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 LVAD Pump and Pock Controller Kit; 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.
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.