FDA-Device2026-03-11Class IPROCESSING DEFECT
Abiomed Impella RP with SmartAssist recalled for pressure sensor malfunction
What this means
The differential pressure sensor in certain Abiomed Impella RP heart pump devices may malfunction and provide inaccurate readings. This could affect the device's ability to monitor and respond appropriately during use. About 291 devices worldwide are affected.
- Contact Abiomed immediately if you or a family member is using an Impella RP device
- Do not rely on sensor readings without verifying with your healthcare provider
- Work with your medical team to determine next steps for your specific situation
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
291 units
Manufactured in
22 Cherry Hill Dr, N/A, Danvers, MA, United States
Products
Impella RP with SmartAssist. Product Code: 0046-0035.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1469-2026More 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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