Certain Automated Impella Controllers (AICs), the main control interface for the Impella catheter (Abiomed/Johnson & Johnson MedTech), should not be used after another issue potentially affecting pump ...
The Impella heart pump is a small pump that a healthcare professional can insert without surgery. It can help maintain blood flow in people who have CAD, are recovering from cardiogenic shock, or are ...
Abiomed is recalling all Impella left-sided blood pumps in the US over a potential safety issue when used in patients with a transcatheter aortic valve replacement (TAVR) stent ― something that is not ...
DANVERS, Mass.--(BUSINESS WIRE)--Abiomed (Nasdaq: ABMD) announces the U.S. Food and Drug Administration (FDA) has accepted and closed the post-approval study reports related to the pre-market ...
For Abiomed’s beleaguered family of Impella heart pumps, Class I recalls are becoming a monthly event. The devices have racked up their third recall in as many months, the latest of which focuses on ...
BOSTON, MA—While the medical community awaits updated guidelines on the use of mechanical circulatory support (MCS) following the DanGer Shock trial, experts here at THT 2025 debated how strong any ...
Johnson & Johnson's (NYSE:JNJ) Abiomed unit has issued a recall for some of its Impella 5.5 with Smart Assist heart pumps over concerns that leaks could cause the pump to stop, which could result in ...
According to the World Health Organization, diseases of the circulatory system, including heart disease such as heart attacks, are still among the most common causes of death worldwide. Recovering the ...
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 ...
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, ...