Recalls for HeartMate II LVAS Pocket System Controller

Thoratec Corporation Issues Worldwide Urgent Medical Device Correction Letter to Update its Labeling Regarding the Use of the HeartMate II® LVAS Pocket System Controller
03/05/2014 Food Recall

On March 4, 2014, Thoratec Corporation initiated a voluntary worldwide Medical Device Correction in order to update its labeling and training materials for the HeartMate II® LVAS Pocket System Controller (the “Pocket Controller”).

  • Company:
    Thoratec Corporation
  • Problem
    Difficulties encountered when changing from a primary system controller to a backup system controller