"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.