Health Canada — Medical Devices · Canada · 2026-04-28 · Type I
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Reported risk: 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.
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