DANVERS, Mass.--(BUSINESS WIRE)--The United States Food and Drug Administration (FDA) has granted 510(k) clearance to Abiomed (Nasdaq: ABMD) for its Impella Low Profile Sheath. Compared to the ...
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 ...
Abiomed has issued a “device correction” for all types of its Impella left-sided mechanical circulatory support devices because the pumps’ labeling does not fully address the precautions needed when ...
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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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