Abiomed, Inc. recalls Impella RP with SmartAssist. Product Code: 0046-0035.
- Recalling company
- Abiomed, Inc.
- Product
- Impella RP with SmartAssist. Product Code: 0046-0035.
- Reason
- Differential pressure (dP) sensor in Impella RP devices may malfunction, causing sensor values to drift.
- Classification
- Class I – a reasonable probability that use will cause serious adverse health consequences or death
- Recall date
- Jan 27, 2026
- Reported
- Mar 11, 2026
- Distribution
- Worldwide distribution - US Nationwide and the countries of Austria, Canada, Croatia, Czechia, France, Germany, Hong Kong, Italy, Poland, Serbia, Switzerland.
- Status
- Ongoing
- Quantity
- 291 units
- Lot / codes
- Product Code: 0046-0035. UDI-DI: 00813502011869.
- Company location
- Danvers, MA
- Recall type
- Voluntary: Firm initiated
- Recall number
- Z-1469-2026
- Agency
- U.S. Food and Drug Administration (FDA)
View official FDA notice ↗ Search recall number Z-1469-2026 in the FDA Enforcement Report. Also see FDA recall press releases.
If you use this product, check the lot, NDC or model number against the official notice and follow its instructions. Do not stop a prescribed medicine or remove a medical device without talking to your doctor or pharmacist. Report problems to FDA MedWatch. FoodRecallNow summarizes public FDA data and is not medical advice.