Serious riskFDA DeviceMar 11, 2026Class I

Abiomed Impella RP Flex device recalled for possible sensor drift

The differential pressure sensor in some Abiomed Impella RP Flex with SmartAssist heart pump devices may malfunction, causing inaccurate sensor readings. This is a Class I recall affecting approximately 4,496 devices 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 have an Impella RP Flex device, contact your healthcare provider or Abiomed immediately
Do not discontinue use without medical guidance—work with your doctor on next steps
Verify your device's product code (1000323) and UDI-DI (00813502012811) against Abiomed's recall information

Official notice ↗

Is yours affected?

Compare your label or packaging with the recalled product.

Product: Impella RP Flex with SmartAssist. Product Code: 1000323.
Sold in: Nationwide
Made for: Adults (0 months and older)

This recall covers 3 products — see all of them.

Details

Units affected: 4,496 units
Illnesses reported: None reported
Manufactured in: 22 Cherry Hill Dr, N/A, Danvers, MA, United States
Classification: Class I
Recall number: Z-1470-2026

In the FDA's words

Description: Impella RP Flex with SmartAssist. Product Code: 1000323. Differential pressure (dP) sensor in Impella RP devices may malfunction, causing sensor values to drift. Product Code: 1000323. UDI-DI: 00813502012811. Distribution: Worldwide distribution - US Nationwide and the countries of Austria, Canada, Croatia, Czechia, France, Germany, Hong Kong, Italy, Poland, Serbia, Switzerland. Affected quantity: 4,496 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. (this page)
Z-1470-2026 · 4,496 units
Impella RP. Product Code: 0046-0011.
Z-1471-2026 · 179 units