FDA Device Recall Z-1471-2026

Abiomed, Inc. · Danvers, MA

Class I — life-threatening Ongoing

Highest impact — Class I device recall — FDA determination that use of, or exposure to, the device will cause serious adverse health consequences or death. Distribution is nationwide and the recall remains in progress.

Device

Impella RP. Product Code: 0046-0011.

Lot / serial / GTIN: Product Code: 0046-0011. UDI-DI: 04260113630273. Distributed outside the US.

Quantity: 179 units

Reason for recall

Differential pressure (dP) sensor in Impella RP devices may malfunction, causing sensor values to drift.

Recall record

Recall number: Z-1471-2026
Classification: Class I
Status: Ongoing
Voluntary or mandated: Voluntary: Firm initiated
Firm notification: Letter
Distribution: Worldwide distribution - US Nationwide and the countries of Austria, Canada, Croatia, Czechia, France, Germany, Hong Kong, Italy, Poland, Serbia, Switzerland.
Recall initiated: 2026-01-27
Classified by FDA Center: 2026-02-27
FDA published: 2026-03-11
Recalling firm: Abiomed, Inc.
Firm location: Danvers, MA

Operational response

A Class I device recall indicates a strong likelihood of serious adverse health consequence or death from continued use. Identify affected units by serial number, lot, or GTIN against your inventory and against implanted-device patient registry. Pull affected inventory from active use immediately. For implanted devices, follow the recalling firm’s patient-notification protocol; in most cases this requires informing affected patients and their treating physicians directly.

For the official FDA enforcement record, see FDA's Recall Search.

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