Automated Impella® Controller

Product Automated Impella® Controller Issue Medical devices - Performance What to do Contact the manufacturer if you require additional information. Audience Healthcare

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.

Automated Impella® Controller

RA-81986