FDA-Device2026-03-11Class IPROCESSING DEFECT
Abiomed Impella RP Flex 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 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
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
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, Inc. recalls
- FDA-Device2026-06-03Abiomed Impella Controller recalled for alarm failures and cassette misalignment
- FDA-Device2026-06-03Abiomed Impella Controller recalled for hardware defects affecting motor control and device function
- FDA-Device2026-04-08Abiomed Impella Controller recalled for delayed alarm display with Impella 5.5 pumps
- FDA-Device2026-04-08Abiomed Impella Pump Set purge cassettes recalled for increased leak risk
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