FDA-Device2026-03-11Class IPROCESSING DEFECT
Abiomed Impella RP heart pump recalled for sensor malfunction risk
OTHERNationwide distribution
Stop using affected Abiomed Impella RP devices
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
Hazard
Differential pressure (dP) sensor in Impella RP devices may malfunction, causing sensor values to drift.
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, Inc. recalls
- FDA-Device2026-07-22Abiomed Impella CP heart pump introducer recalled for potential sheath leakage
- FDA-Device2026-07-22Abiomed Impella CP Introducer Kit recalled for potential fluid leakage
- FDA-Device2026-07-22Abiomed Impella CP heart pump recalled for introducer sheath leakage risk
- FDA-Device2026-07-22Abiomed Impella 5.5 SmartAssist S2 heart pump recalled for introducer sheath leakage risk
- FDA-Device2026-07-22Abiomed Impella RP Flex heart pump recalled for introducer sheath leakage risk
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