Automated Impella Controller (AIC) - A retrospective review identified that there are AIC units requiring specific hardware updates to address potential safety concerns. These hardware updates have been implemented through Abiomed s servici

Source: FDA | Recall date: 06/03/2026

Don't want to manually check every recall?

Track your baby products and get automatic recall alerts when something may affect your family.

Start Free Recall Tracking How Tracking Works

Learn more about the baby product recall tracker, automatic email item adding, or recall monitoring plans.

Affected product: Automated Impella Controller (AIC)

Summary: A retrospective review identified that there are AIC units requiring specific hardware updates to address potential safety concerns. These hardware updates have been implemented through Abiomed s servicing process; therefore, AICs that have not received service are pending these

Hazard: A retrospective review identified that there are AIC units requiring specific hardware updates to address potential safety concerns. These hardware updates have been implemented through Abiomed s servicing process; therefore, AICs that have not received service are pending these

Open Official Recall Notice Back to Home

Don't want to manually check every recall?

Track your baby products and get automatic recall alerts when something may affect your family.

Start Free Recall Tracking How Tracking Works

Learn more about the baby product recall tracker, automatic email item adding, or recall monitoring plans.