Impella devices have been the subjects of a series of Abiomed letters and FDA early alerts and recall notices. In January, Abiomed sent an urgent medical device correction about a malfunction risk ...

The U.S. FDA posted notice of a medical device correction of Abiomed Inc.'s Impella series of left-side blood pumps because of the risk of perforation of the left ventricle during device placement.

For patients who have acute MI with cardiogenic shock (AMICS), Medicare claims data aren’t detailed enough to show whether use of the Impella percutaneous microaxial left ventricular assist device ...