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Heart Pumps

All articles tagged with #heart pumps

health1 year ago•2 min saved

"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.

via Fox Business|

#abbott-laboratories #fda-recall #health

health1 year ago•6 min saved

"FDA Recalls Abbott Heart Pumps After 14 Deaths, 270+ Injuries"

The FDA has issued a Class 1 recall for the HeartMate II and HeartMate 3 heart pumps, manufactured by Thoratec Corp., due to hundreds of injuries and at least 14 deaths. The devices, used for end-stage heart failure patients, have been associated with a buildup of "biological material" that reduces their ability to circulate blood, leading to serious complications. Abbott Laboratories, the manufacturer, has communicated the risk to customers and is working with the FDA to investigate the reported injuries and deaths. The delayed action has raised concerns about transparency and reporting of issues with approved medical devices, as physicians are not mandated to report adverse events to federal regulators.

via CBS News|

#abbott-laboratories #fda #health