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Recall Observatory FDA recall evidence

Device product

Impella CP intravascular micro axial blood pump, Product Number 0048-0032

Z-2115-2023

June 14, 2023

Class I

Product summary

Firm
Abiomed, Inc.
Event
Event 92321
Status
Ongoing
Classification
Class I
Quantity
9252 units
Official record key
device-enforcement:Z-2115-2023

Official wording

Reason: 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.

Code information: UDI-DI: 00813502011388;

Distribution pattern: Worldwide distribution - US Nationwide.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.