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 ...

The use of left-sided Impella microaxial flow pumps has expanded rapidly for the management of cardiogenic shock, left ...

Device manufacturer Abiomed has recalled the labeling for various models of its left-sided heart pumps due to the potential for the pump catheter to perforate the left ventricle’s wall, the US Food ...

Abiomed is recalling the instructions for use (IFU) for its Impella left-sided blood pumps because the pump catheter may perforate the wall of the left ventricle. According to the recall notice, "use ...