FDAHealthJanuary 27, 2026
Abiomed, Inc. — Impella RP. Product Code: 0046-0011.
⚠️ Differential pressure (dP) sensor in Impella RP devices may malfunction, causing sensor values to drift.
Is this relevant to me?
- Geography
- Nationwide
- Source agency
- FDA
- Category
- Health
- Published
- January 27, 2026
Worldwide distribution - US Nationwide and the countries of Austria, Canada, Croatia, Czechia, France, Germany, Hong Kong, Italy, Poland, Serbia, Switzerland.
What's affected?
- Product
- Impella RP. Product Code: 0046-0011.
- Brand
- Abiomed, Inc.
- Lot code
- Product Code: 0046-0011. UDI-DI: 04260113630273. Distributed outside the US.
Additional details
Product Code: 0046-0011. UDI-DI: 04260113630273. Distributed outside the US.
What should I do?
Recommended action
Class I recall. Voluntary: Firm initiated Quantity affected: 179 units.
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