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-Device2026-06-03Abiomed 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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