Z-2111-2023 Class I Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- July 26, 2023
- Initiation Date
- June 14, 2023
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 9252 units
Product Description
Impella 2.5 intravascular micro axial blood pump, Product Number 005042
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 Pattern
Worldwide distribution - US Nationwide.
Code Information
UDI-DI: 00813502011081;