"FDA Recalls Heart Pumps Linked to 14 Deaths and Hundreds of Injuries"

The FDA has announced the voluntary recall of nearly 14,000 HeartMate II and HeartMate 3 Left Ventricular Assist System (LVAS/LVAD) heart pumps produced by Abbott Laboratories' Thoratec Corp. due to an issue called Extrinsic Outflow Graft Obstruction, which can lead to serious injuries or death. The devices work by assisting the heart's pumping function, but biological material buildup can obstruct the device over time, affecting its effectiveness. There have been 273 reported injuries and 14 deaths associated with this issue, and while the devices remain on the market, Abbott has communicated with customers about the potential problem and provided recommendations for early detection and treatment.