Impella RP with SmartAssist. Product Code: 0046-0035.
FDA Recall #Z-1469-2026 — Class I — January 27, 2026
Product Description
Impella RP with SmartAssist. Product Code: 0046-0035.
Reason for Recall
Differential pressure (dP) sensor in Impella RP devices may malfunction, causing sensor values to drift.
Recalling Firm
Abiomed, Inc. — Danvers, MA
Classification
Class I — Reasonable probability of serious adverse health consequences or death.
Product Type
Devices
Product Quantity
291 units
Distribution
Worldwide distribution - US Nationwide and the countries of Austria, Canada, Croatia, Czechia, France, Germany, Hong Kong, Italy, Poland, Serbia, Switzerland.
Code Information
Product Code: 0046-0035. UDI-DI: 00813502011869.
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated