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 ...

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 ...

With medical devices, recalls are not always what they seem. In some recalls, including some of the most serious, the FDA and the manufacturers let doctors and hospitals continue to use the devices.

The devices are implanted in patients with end-stage heart failure who are waiting for a transplant or as a permanent solution when a transplant is not an option. The recall affects nearly 14,000 ...

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 ...

"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 manufactured by a subsidiary of North Chicago-based Abbott Laboratories has received the FDA’s most serious recall after being linked to hundreds of injuries and at least ...

With medical devices, recalls are not always what they seem. In some recalls, including some of the most serious, the FDA and the manufacturers let doctors and hospitals continue to use the devices.

A pair of heart devices linked to hundreds of injuries and at least 14 deaths has received the FDA’s most serious recall, the agency announced Monday.. The HeartMate 3 is considered the safest ...

In other cases, recalls that don’t remove devices from the market can provide unwarranted reassurance and leave the public at risk, Dhruva said. From 2019 through 2023, there were 338 Class I medical ...

In 2016, medical device giant Abbott issued a recall for its MitraClip cardiac device — “a Class I recall, the most serious type,” the FDA said. “Use of this device may cause serious ...