Abiomed, Inc. recalls Impella 5.0 intravascular micro axial blood pump, Product Nu
Recalled Product
Impella 5.0 intravascular micro axial blood pump, Product Number 005062
Hazard / Issue
There is a potential risk for unintentional interaction of the Impella motor housing with the distal stent of a transcatheter aortic valve replacement (TAVR) resulting in destruction of the impeller blades. This has resulted in low flow from the damaged Impella system. Systemic embolization of the fractured impeller material is a possibility.
Issued by
FDA
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