Two implanted heart devices used by patients in end-stage heart failure are now under a strict U.S. Food and Drug Administration recall, after being tied to 273 known injuries and 14 deaths ...

The devices, small enough to fit in the palm of a hand, are implanted ... FDA's recall notice, the devices can cause buildup of "biological material" that reduces their ability to help the heart ...

"When deciding whether a recall warrants device removal from the field, the FDA considers the frequency ... system includes tiny clips implanted in the heart's mitral valve and the equipment ...

Two implanted heart devices used by patients in end-stage heart failure are now under a strict U.S. Food and Drug Administration recall, after being tied to 273 known injuries and 14 deaths, the ...

The device can be used by patients awaiting a heart transplant or ... a HeartMate II or HeartMate 3 implant. That information is proprietary. The FDA recall notices show worldwide distribution ...

The US Food and Drug Administration (FDA) has granted breakthrough device designation to BiVACOR’s titanium Total Artificial ...

“When deciding whether a recall warrants device removal from the field, the FDA considers the frequency ... system includes tiny clips implanted in the heart’s mitral valve and the equipment ...

A pair of heart devices linked to hundreds ... have received a HeartMate II or HeartMate 3 implant. That information is proprietary. The FDA recall notices show worldwide distribution of more ...

“When deciding whether a recall warrants device removal from the field, the FDA considers the frequency and severity ... Abbott’s MitraClip system includes tiny clips implanted in the heart’s mitral ...