There are new and revised warnings about the instructions for use of a certain type of heart pump that could lead to a risk of heart perforation, according to an alert issued by the pump's ...
The use of left-sided Impella microaxial flow pumps has expanded rapidly for the management of cardiogenic shock, left ...
DANVERS, Mass.--(BUSINESS WIRE)--Abiomed (Nasdaq: ABMD) announces the U.S. Food and Drug Administration (FDA) has accepted and closed the post-approval study reports related to the pre-market ...
Abiomed updated warnings on more than 60,000 Impella Left Sided Heart Pumps because the device might cut the wall of the heart’s left ventricle, the FDA said March 21. After 129 serious injuries, ...
The labeling for several mechanical circulatory support devices is under a sweeping class I recall due to the risk of left ventricle perforations, the FDA announced Wednesday. While not subject to a ...
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