Official recall record
Impella Controller (ref 82061)
- Issuing authority
- Health Canada — Medical Devices
- Published
- 2026-05-13
- Country of alert
- Canada
- Alert level
- Type I
- Alert type
- recall
What the authority reported
Abiomed, Inc. has issued a voluntary device recall (correction) to notify customers of a potential software error in the Automated Impella Controller ("AIC") which may be forced to restart when used in conjunction with left ventricular Impella devices. This potential software error, in a specific clinical circumstance, could contribute to serious injury or death in certain patient populations. Product is not being removed, and hospital inventory can continue to be used.
What to do
Follow the instructions in the official notice — recall remedies (refund, repair, replacement, or disposal) are defined by the issuing authority and the responsible business, and they differ per recall. Do not rely on summaries, including this one.
Verify at the source:
Health Canada — Medical Devices — official record →
Record last checked against the registry on 2026-05-31.
Record last checked against the registry on 2026-05-31.
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