Official recall record
Automated Impella® Controller (ref 81986)
- Issuing authority
- Health Canada — Medical Devices
- Published
- 2026-04-28
- Country of alert
- Canada
- Alert level
- Type I
- Alert type
- recall
What the authority reported
Abiomed, Inc. has initiated a voluntary medical device recall (removal) of specific Automated Impella® Controllers (AIC) (Product Code: 0042-0000-CA). A retrospective review of servicing records identified that certain AIC units require specific hardware updates to address potential safety concerns. These updates are intended to mitigate risks that could lead to a delay or loss of hemodynamic support, which may result in serious injury or death.
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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