Abbott has recalled the HeartMate Touch Communication System due to potential issues with the HeartMate 3 left ventricular assist device where the pump may unexpectedly stop or start. This can lead to serious adverse health consequences including lightheadedness, loss of consciousness, and even death. The FDA has classified this recall as Class I, the most serious type. There have been eight reported injuries but no deaths. The recall affects 1560 systems distributed in the US between May 7, 2020, and December 18, 2023. Abbott has provided guidance on how to handle the issue and customers with questions can contact Abbott Technical Support.
Source link
Abbott Recalls HeartMate Touch System
