Impella devices have been the subjects of a series of Abiomed letters and FDA early alerts and recall notices. In January, Abiomed sent an urgent medical device correction about a malfunction risk ...

The FDA today issued a warning related to certain heart pump technologies made by Johnson & Johnson MedTech's Abiomed unit.

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 ...

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 ...

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.

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.

Johnson & Johnson’s (NYSE:JNJ) Abiomed has issued an Early Alert regarding its Automated Impella Controllers (AIC) for Impella heart pumps, a device crucial for patients with severe heart conditions.

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 ...

WAILUKU (HawaiiNewsNow) - The world’s smallest heart pump has made its way to Maui. Nine months after launching at Maui Memorial Medical Center, the island’s only acute-care hospital, it has saved ...

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 ...