FDA-Device2023-07-26Class I
Impella 5.5 with SmartAssist intravascular micro axial blood pump, Product Numbers 0550-0008 and 1000100
Abiomed, Inc.
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.
Sold states
Worldwide distribution - US Nationwide.
Affected count
9252 units
Manufactured in
22 &, 24 Cherry Hill Dr, Danvers, MA, United States
Products
Impella 5.5 with SmartAssist intravascular micro axial blood pump, Product Numbers 0550-0008 and 1000100
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2114-2023Don't want to check this manually?
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