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On March 20, 2017, Abbott-Thoratec issued a recall of 28,882 HeartMate II LVAS Pocket System Controllers following reports of at least 70 malfunctions after patients attempted to exchange controllers while away from the hospital. The FDA recall notice reports that these malfunctions resulted in 19 injuries and 26 deaths. The recalled Model/Item numbers are 105109, 106015, 106762 and 107801, and were distributed between July 2012 and December 2016.
The law firm of Meshbesher and Spence is currently investigating claims involving the recalled Pocket System Controllers. If you or a loved one suffering injury after a malfunction of this device, call us today for a free consultation.