Abiomed, Inc. Recall
Impella RP with SmartAssist. Product Code: 0046-0035.
Updated January 27, 2026
Abiomed, Inc. is recalling Impella RP with SmartAssist. Product Code: 0046-0035.. Hazard: Differential pressure (dP) sensor in Impella RP devices may malfunction, causing sensor values to drift.
Is the Abiomed, Inc. recalled? Yes. This product was recalled by FDA on January 27, 2026. Details below.
What is recalled
Impella RP with SmartAssist. Product Code: 0046-0035.
Am I affected
You may be affected if you own this product. Check the brand, model, and lot/date codes listed in the recall against your item.
What to do right now
Voluntary: Firm initiated
The hazard
Differential pressure (dP) sensor in Impella RP devices may malfunction, causing sensor values to drift.
Brands affected
- Source
- FDA
- Category
- Drugs & Medications
- Recall ID
- fda-Z-1469-2026
- Classification
- Class I
- Recalled
- January 27, 2026
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