CLEVELAND — Forty-one-year-old Mark Kader is a husband, father of five, registered nurse, and associate clinical consultant for Abiomed, a medical device company. He's passionate about educating ...

Abiomed ($ABMD) gained FDA clearance for another iteration of its Impella heart pump, an important win for a product line that's become vital to Abiomed's bottom line ...

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.

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 ...

After the FDA handed out a Class I label earlier this month for a recall of miniaturized internal heart pumps developed by Johnson & Johnson’s Abiomed division, an update from the agency has now ...

Recent drug device recalls include Olympus endoscope needles, Abiomed heart pump controllers, and Teva blood pressure drug over cancer risk.

Abiomed is recalling some of its Impella 5.5 with SmartAssist devices in response to complaints about purge fluid leaking from the purge sidearm of the pump. Today, the US Food and Drug Administration ...

NEW ORLEANS – The Impella 5.0 and 5.5 left ventricular assist device failed to measure up on outcomes when used for high-risk patients undergoing ventricular tachycardia (VT) ablation therapies, ...

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 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 ...