Abiomed is recalling the instructions for use (IFU) for its Impella left-sided blood pumps due to the risk of serious health consequences. The US FDA has classified this as a Class I recall, with 129 reported serious injuries and 49 deaths. The affected devices include Impella 2.5, Impella CP, Impella CP with SmartAssist, Impella 5.0, Impella 5.5 with SmartAssist, and Impella LD.
Abiomed is recalling the instructions for use (IFU) for its Impella left-sided blood pumps due to the risk of the pump catheter perforating the wall of the left ventricle. The US FDA has classified this as a Class I recall, the most serious type, as it may cause serious adverse health consequences, including left ventricle perforation or free wall rupture . There have been 129 reported serious injuries, including 49 deaths. The affected devices include Impella 2.
5, Impella CP, Impella CP with SmartAssist, Impella 5.0, Impella 5.5 with SmartAssist, and Impella LD
Abiomed Impella Blood Pumps Recall Instructions For Use Left Ventricle Perforation Free Wall Rupture FDA Class I Recall Serious Injuries Deaths
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