Impella 5.5 with SmartAssist intravascular micro axial recall
Impella 5.5 with SmartAssist intravascular micro axial blood pump, Product Numbers 0550-0008 and 1000100
Why was Impella 5.5 with SmartAssist intravascular micro axial 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.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
UDI-DI: 00813502011531, 00813502012828;
- Product
- Impella 5.5 with SmartAssist intravascular micro axial blood pump, Product Numbers 0550-0008 and 1000100
- Recalling firm
- Abiomed, Inc.
- Quantity
- 9252 units
- Distribution
- Worldwide distribution - US Nationwide.
- Recall date
- July 26, 2023
- Classification
- Class I
- Status
- Ongoing
- Agency
- FDA (device)