Impella RP recall
Impella RP. Product Code: 0046-0011.
Why was Impella RP recalled?
Differential pressure (dP) sensor in Impella RP devices may malfunction, causing sensor values to drift.
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?
Product Code: 0046-0011. UDI-DI: 04260113630273. Distributed outside the US.
- Product
- Impella RP. Product Code: 0046-0011.
- Recalling firm
- Abiomed, Inc.
- Quantity
- 179 units
- Distribution
- Worldwide distribution - US Nationwide and the countries of Austria, Canada, Croatia, Czechia, France, Germany, Hong Kong, Italy, Poland, Serbia, Switzerland.
- Recall date
- March 11, 2026
- Classification
- Class I
- Status
- Ongoing
- Agency
- FDA (device)