Impella 5.0 intravascular micro axial blood pump, Product Number 005062
Reported: July 26, 2023 Initiated: June 14, 2023 #Z-2112-2023
Product Description
Impella 5.0 intravascular micro axial blood pump, Product Number 005062
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.
Details
- Recalling Firm
- Abiomed, Inc.
- Units Affected
- 9252 units
- Distribution
- Worldwide distribution - US Nationwide.
- Location
- Danvers, MA
Frequently Asked Questions
What product was recalled? ▼
Impella 5.0 intravascular micro axial blood pump, Product Number 005062. Recalled by Abiomed, Inc.. Units affected: 9252 units.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on July 26, 2023. Severity: Critical. Recall number: Z-2112-2023.
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