Recall Monitor
Health ProductsType I recall

Automated Impella® Controller

· Published by Health Canada · Official notice

Details

Alert type: Health product recall
Category: Health products - Medical devices - Cardiovascular
Product: Automated Impella® Controller
Issue: Medical devices - Performance
What to do: Contact the manufacturer if you require additional information.
Audience: Healthcare
Recall class: Type I
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Products

Affected productsLot or serial numberModel or catalogue number
Automated Impella® ControllerIC23690042-0000-CA
Automated Impella® ControllerIC23700042-0000-CA
Automated Impella® ControllerIC15720042-0000-CA
Automated Impella® ControllerIC26860042-0000-CA
Automated Impella® ControllerCI16650042-0000-CA
Automated Impella® ControllerIC15440042-0000-CA
Automated Impella® ControllerIC26870042-0000-CA

Issue

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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