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 ...

A new warning is being issued over a heart pump whose use could perforate the heart. The device has already been linked to over 100 injuries and 49 deaths. These left-sided Impella heart pumps are ...

A troubled heart pump that has now been linked to 49 deaths and dozens of injuries worldwide will be allowed to remain in use, despite the Food and Drug Administration’s decision to issue an alert ...

Johnson & Johnson’s Abiomed division is once again the subject of a Class I recall for its Impella heart pumps, this time pertaining to a potential safety conflict in patients with transcatheter ...

The Food and Drug Administration (FDA) has issued a Class I recall, the highest-level alert, for heart pumps that have been linked to nearly 50 deaths. Impella heart pumps are used for short term ...

A pricey high-tech pump that maintains blood flow during heart procedures could be more dangerous to patients than its low-tech predecessor, a pair of recent studies finds. The Impella device is ...

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 ...

With only a 50% survival rate, the heart attack complication known as cardiogenic shock is one of the direst challenges faced by emergency room and ICU clinicians. A dangerous sudden worsening in ...

When he was 25 years old, Thorsten Siess, a mechanical engineering student at the University of Aachen in Germany had an idea: What if there was a way to keep the heart pumping blood during surgery or ...