FDA-Device2026-03-11Class IPROCESSING DEFECT
Abiomed Impella RP heart pump recalled for sensor malfunction risk
What this means
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.
- 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
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
179 units
Manufactured in
22 Cherry Hill Dr, N/A, Danvers, MA, United States
Products
Impella RP. Product Code: 0046-0011.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1471-2026More 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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