Johnson & Johnson’s Abiomed has asked customers to quarantine certain Impella devices over a risk linked to four serious injuries, the Food and Drug Administration said Wednesday. Abiomed wrote to ...

On Thursday, Johnson & Johnson’s (NYSE:JNJ) Abiomed said it is recalling its Impella Left Sided Blood Pumps because the pump catheter may perforate (cut) the wall of the left ventricle in the heart.

Add Yahoo as a preferred source to see more of our stories on Google. The Food and Drug Administration issued an early alert for a correction of Abiomed's Impella RP Flex heart pumps. (Courtesy of ...

DANVERS, Mass.--(BUSINESS WIRE)--The United States Food and Drug Administration (FDA) has granted breakthrough device designation to Abiomed’s (NASDAQ: ABMD) Impella ECP expandable percutaneous heart ...

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.

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 ...

Physicians forced to make rapid-fire choices, with limited evidence, in acute myocardial infarction complicated by cardiogenic shock (AMICS) finally have what they’ve long been waiting for: positive ...

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 ...

SALT LAKE CITY, March 11, 2025 /PRNewswire/ — In a transformative recent study, the Second Heart Assist Inc. Whisper™ device, a next-generation percutaneous mechanical circulatory support (pMCS) ...

ATLANTA -- Routine use of the Impella CP microaxial flow pump significantly improved survival in patients with infarct-related cardiogenic shock, the randomized DanGer Shock trial showed. In more than ...

The US Food and Drug Administration (FDA)-approved labeling for the Impella 5.0 and Impella LD heart pumps (Abiomed) has been expanded to allow for longer support time in critically ill patients, the ...