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 ...

These include 600,000 coronary stents, 200,000 implantable pacemakers, about 200,000 heart ... if the FDA approved their devices after premarket testing, she said. Most device recalls are based ...

When someone’s heart doesn’t beat quite right, an implantable ... That recall is just one of 157 captured in a new analysis of cardiovascular devices in Annals of Internal Medicine by a ...

Abbott Laboratories has announced that its implantable heart device, MitraClip, has not been recommended for approval by reviewers at the US Food and Drug Administration. Clinical trials ...

In 2013, the FDA approved an implantable device to treat leaky heart valves ... in the MitraClip line have been the subject of three recalls. A former employee has alleged in a federal lawsuit ...

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.