Recall of HeartMate II LVAS Pocket System Controllers
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…