Abiomed Impella Controller recalled for alarm failures and cassette misalignment
Abiomed Impella Controller recalled for electrical and alignment faults
Certain Impella Controller (AIC) consoles contain electrical faults including alarm failures, power-path problems, and inaccurate motor sensing. Additionally, improper alignment between the purge cassette and motor drive can prevent the purge system from priming correctly, requiring users to switch to a backup console.
- Check if your Impella Controller serial number matches the recalled list provided by Abiomed
- Contact your Abiomed representative or device supplier for inspection or replacement
- Ensure a backup AIC console is available if your unit is affected
Retrospective submission for following issues identified: 1. Alarm failures, power-path faults, electrical-short risks, and inaccurate motor-current sensing were identified in certain AIC consoles. 2. There is improper alignment between the purge cassette and the motor drive in the AIC. This can result in a piston block event and lead to the inability to complete priming of the purge system, requiring the user to switch to backup AIC console.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2238-2026More Abiomed, Inc. recalls
- 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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