After a 2023 marred by recalls and FDA wrath, Johnson & Johnson subsidiary Abiomed has once again issued a recall connected to its Impella blood pumps. Categorized as Class I, the most recent recall ...
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 ...
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 ...
March 21 (Reuters) - The U.S. health regulator on Thursday classified corrections made to the instructions for the use of blood pumps manufactured by Johnson & Johnson's (JNJ.N), opens new tab Abiomed ...
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