Thoratec (THOR) issues a global Medical Device Correction in order to update its labeling and training materials for its HeartMate II LVAS Pocket System Controller because some patients and caregivers have had difficulty changing from the primary system controller to the backup system controller.
The difficulties have resulted in four deaths and five cases of unconsciousness and other symptoms of hypoperfusion. Two of the deaths occurred when patients tried to exchange the controllers while alone and without contacting the hospital first per the labeling.
The company sent the Device Correction Notices to hospitals today.
The advisory applies to all HeartMate II LVAS Pocket Controllers manufactured and distributed worldwide to date.
The Pocket Controller has been prescribed to 2,142 patients either at the time of the HeartMate implantation or as a replacement of an older System Controller model. The latter group is at greater risk of having difficulty in the exchange process due to inadequate training on the differences in the models.
Management has notified the FDA and other competent authorities of this action.
Investors should expect abnormal volatility in tomorrow's trading.