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 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 ...

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 ...

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 ...

Before he got a HeartMate 3 implanted in January 2022, Sid Covington, of Austin, Texas, said he had researched the device during years of medication therapy and cardiac rehabilitation to treat his ...

The FDA categorized this the most serious type of recall because battery failure can stop the heart device from working, possibly leading to death. For some end-stage heart failure patients, the ...

Grandbrothers. The U.S. Food and Drug Administration (FDA) classified the recall of Getinge's (OTCPK:GNGBF) (OTCPK:GNGBY) heart devices as the agency's Class 1 recall, the most serious type of ...

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 recall comes years after surgeons say ...

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 ...

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.