Abiomed has announced a recall of some Impella 5.5 with SmartAssist systems after receiving complaints from customers reporting purge fluid leaking from the purge sidearm of the pump. The Impella 5.5 ...

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 ...

Abiomed has begun a recall of several hundred of its Impella heart pumps after receiving nearly 200 complaints, and the FDA this week gave it a Class I rating, indicating a heightened risk of injury ...

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 ...

The use of left-sided Impella microaxial flow pumps has expanded rapidly for the management of cardiogenic shock, left ...

Abiomed is recalling the instructions for use (IFU) for its Impella left-sided blood pumps because the pump catheter may perforate the wall of the left ventricle. According to the recall notice, "use ...

The FDA has opened up the use of Johnson & Johnson’s miniaturized heart pumps to certain pediatric patients, including those suffering from acute heart failure and cardiogenic shock. The agency ...

Abiomed removed 466 heart pumps from the market after customers complained about leaking fluid from the purge sidearm and three injuries were reported, the FDA said June 5. The device, the Impella 5.5 ...

The U.S. FDA reported a class I recall for a subset of the Impella 5.5 with Smartassist due to leakage of purge fluid from a pump sidearm that could ultimately lead to a loss of pump function. Abiomed ...

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, ...

Impella 2.5, the main product for Danvers, MA-based Abiomed Inc., has received FDA premarket approval (PMA) for use in elective and urgent high-risk percutaneous coronary intervention (PCI) procedures ...

DANVERS, Mass.--(BUSINESS WIRE)--Abiomed (NASDAQ: ABMD) announces the United States Food and Drug Administration (FDA) has approved the company's investigational device exemption application to start ...