FDA Update: Abiomed Recalls Specific Impella 5.5 With SmartAssist Device
On June 5, the U.S. Food and Drug Administration (FDA) announced that Abiomed is recalling specific Impella 5.5 with SmartAssist sets due to reported complications with purge fluid leaking from the purge sidearm of the pump.
The device is used to support the pumping of the heart ventricles for up to 14 days following acute myocardial infarction where ongoing cardiogenic shock is present. Should the leak issue not be resolved, “persistent low purge pressure and purge flow may lead to pump stop and loss of therapy,” causing the agency to identify this as a Class I recall, where use of the device may cause serious injury or death.
For more information and recommendations, access the FDA website.
Keywords: Longitudinal Studies, Myocardial Infarction, Heart Ventricles, Shock, Cardiogenic, United States Food and Drug Administration, ACC Advocacy
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