Abiomed, Inc.: Impella LD intravascular micro axial blood pump, Product Number 005082

Hazard

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.

Details from the source

Reason for recall: 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. Distribution: Worldwide distribution - US Nationwide. Quantity: 9252 units Lot/code info: UDI-DI: 00813502011227;

UPC codes

00813502011227

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.