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 ...

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 ...

Abiomed has recalled 466 of its Impella 5.5 with SmartAssist heart pumps after receiving customer complaints about purge fluid leaking from the purge sidearm of the pump. "If a purge leak occurs, the ...

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 ...

To date, according to the FDA’s recall notice, Abiomed has received 179 complaints related to the issue with its Impella 5.5 devices, including three reported injuries. The company hasn’t received any ...

The FDA has issued an early alert regarding certain Abiomed Impella system components after the company recommended removing specific products from use because of an increased risk of purge leaks. In ...

Please provide your email address to receive an email when new articles are posted on . Abiomed is recalling specific Impella 5.5 left ventricular device systems due to product leakage. The FDA ...

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 ...

More Impella left-sided blood pumps are under Class I recall, this time for potential interactions with transcatheter aortic valve replacement (TAVR) stents, the FDA announced Thursday. The affected ...