HeartMate II LVAS Pocket System Controller by Thoratec Corporation Recalled (Class I) [Update]
[Update] The FDA classified the recall as Class I. Patients have not been intensively trained on connecting the new controller that requires a different approach. Improper connection of the controller causes the device not to function.
The affected devices are:
- HeartMate II Implant Kit with Pocket Controller: Catalog Numbers 106015 and 106016
- Pocket Controller: Catalog Numbers 106762 and 106017
- HeartMate II LVAD Pump and Pocket Controller Kit: Catalog Number 107801
- Pocket Controllers that have been removed from packaging: Model Number 105109 (found on side of each unit)
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