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 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 ...
Johnson & Johnson’s Abiomed division is once again the subject of a Class I recall for its Impella heart pumps, this time pertaining to a potential safety conflict in patients with transcatheter ...
Johnson & Johnson’s Abiomed has asked customers to quarantine certain Impella devices over a risk linked to four serious injuries, the Food and Drug Administration said Wednesday. Abiomed wrote to ...
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 ...
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 has issued a “device correction” for all types of its Impella left-sided mechanical circulatory support devices because the pumps’ labeling does not fully address the precautions needed when ...
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 ...
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 ...
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