Recalls for Thoratec Corporation

HeartMate II Left Ventricular Assist System (LVAS) by Thoratec Corporation: Urgent Medical Device Correction - Monitor the Backup Battery Expiration Date
09/16/2015 Medical Recall

Certain preventable advisory alarms may result in patients deciding to attempt a System Controller exchange.

  • Company:
    Thoratec Corporation
Thoratec Issues Voluntary Device Correction
09/15/2015 Food Recall

Thoratec Corporation (NASDAQ: THOR) today issued a voluntary Urgent Medical Device Correction Letter to all hospitals who have patients supported with the HeartMate II LVAS reminding them to monitor the expiration date of the backup battery contained within the HeartMate II “Pocket” System Controller, as specified in the product Instructions for Use. This backup battery has a 36 month expiration date.

  • Company:
    Thoratec Corporation
  • Problem
    Reminder To Hospitals To Check Backup Battery Expiration
HeartMate II LVAS Pocket System Controller by Thoratec Corporation: Medical Device Correction - Updated Labeling and Training Materials
03/05/2014 Medical Recall

Reports of four deaths and five incidents of loss of consciousness or other symptoms of hypoperfusion, occurring in patients who were converted to the Pocket Controller after being originally trained on an older model.

  • Company:
    Thoratec Corporation
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