Serious riskFDA DeviceMar 11, 2026Class I

Abiomed Impella RP heart pump recalled for possible sensor malfunction

The differential pressure sensor in some Abiomed Impella RP heart pump devices may malfunction, causing inaccurate sensor readings. This affects 179 units distributed worldwide. No injuries have been reported to date.

From the FDA notice · Read the official notice ↗ · All Abiomed recalls

What to do

If you or a family member has an Impella RP device, contact your healthcare provider immediately
Do not stop using your device without medical guidance
Ask your provider about sensor function and whether your device is affected

Official notice ↗

Is yours affected?

Compare your label or packaging with the recalled product.

Product: Impella RP. Product Code: 0046-0011.
Sold in: Nationwide
Made for: Adults (0 months and older)

This recall covers 3 products — see all of them.

Details

Units affected: 179 units
Illnesses reported: None reported
Manufactured in: 22 Cherry Hill Dr, N/A, Danvers, MA, United States
Classification: Class I
Recall number: Z-1471-2026

In the FDA's words

Description: Impella RP. Product Code: 0046-0011. Differential pressure (dP) sensor in Impella RP devices may malfunction, causing sensor values to drift. Product Code: 0046-0011. UDI-DI: 04260113630273. Distributed outside the US. Distribution: Worldwide distribution - US Nationwide and the countries of Austria, Canada, Croatia, Czechia, France, Germany, Hong Kong, Italy, Poland, Serbia, Switzerland. Affected quantity: 179 units
Hazard: Differential pressure (dP) sensor in Impella RP devices may malfunction, causing sensor values to drift.

3 products in this recall

Abiomed Impella RP heart pumps recalled for sensor drift risk

Abiomed is recalling three Impella RP heart pump models because the differential pressure (dP) sensor may malfunction and its readings may drift. The recall covers 4,966 units in total and was distributed in the US and several other countries. No injuries have been reported.

The agency lists each product separately. Check every one you might have.

Impella RP with SmartAssist. Product Code: 0046-0035.
Z-1469-2026 · 291 units
Impella RP Flex with SmartAssist. Product Code: 1000323.
Z-1470-2026 · 4,496 units
Impella RP. Product Code: 0046-0011. (this page)
Z-1471-2026 · 179 units