Impella RP. Product Code: 0046-0011.
FDA Recall #Z-1471-2026 — Class I — January 27, 2026
Product Description
Impella RP. Product Code: 0046-0011.
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
179 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: 0046-0011. UDI-DI: 04260113630273. Distributed outside the US.
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated