Impella CP intravascular micro axial blood pump recall
Impella CP intravascular micro axial blood pump, Product Number 0048-0032
Why was Impella CP intravascular micro axial blood pump 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: 00813502011388;
- Product
- Impella CP intravascular micro axial blood pump, Product Number 0048-0032
- 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)