Abiomed Impella Controller recalled for alarm failures and cassette misalignment
What this means
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
The agency's original wording
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 recalls
- FDA-Device2026-09-30Abiomed Impella Controller recalled for firmware and software defects affecting pressure signal accuracy
- FDA-Device2026-09-23Abiomed Impella Optical Controller recalled for purge cassette recognition failure risk
- FDA-Device2026-09-23Abiomed Impella Optical Controller recalled for purge cassette recognition failure
- FDA-Device2026-09-23Abiomed Impella Controller recalled for purge cassette recognition failure risk
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