FDA-Device2026-03-11Class IPROCESSING DEFECT
Abiomed Impella RP Flex heart pump recalled for sensor malfunction risk
What this means
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.
- 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
The agency's original wording
Hazard
Differential pressure (dP) sensor in Impella RP devices may malfunction, causing sensor values to drift.
Intended for
Adults
Illnesses reported
None reported
Sold states
Worldwide distribution - US Nationwide and the countries of Austria, Canada, Croatia, Czechia, France, Germany, Hong Kong, Italy, Poland, Serbia, Switzerland.
Affected count
4,496 units
Manufactured in
22 Cherry Hill Dr, N/A, Danvers, MA, United States
Products
Impella RP Flex with SmartAssist. Product Code: 1000323.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1470-2026More Abiomed recalls
- FDA-Device2026-07-22Abiomed Introducer Kit 23 Fr recalled for potential sheath leakage risk
- FDA-Device2026-07-22Abiomed Impella CP Smart Assist Set recalled for introducer sheath leakage risk
- FDA-Device2026-07-22Abiomed Intro Kit heart pump introducer recalled for potential fluid leakage risk
- FDA-Device2026-07-22Abiomed Impella CP heart pump recalled for introducer sheath leakage risk
- FDA-Device2026-07-22Abiomed Impella 5.5 Smart Assist Set recalled for introducer sheath leakage risk
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