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Early Recall Alert: Abiomed Automated Impella Controllers (AIC) – may not detect Impella pump

Early Recall Alert: Abiomed Automated Impella Controller (AIC) - see what data Equiptrack clients have access to before the FDA Recall

WHAT IS THIS?

This Early Recall Alert communication is part of the Communications Pilot to Enhance the Medical Device Recall Program.

The FDA has become aware of a potentially high-risk issue.

EARLY ALERT INFORMATION

Why this Early Recall Alert is important:

Abiomed’s Automated Impella Controller (AIC) were recently recalled due to:

— AIC may not detect an Impella pump when connected

— Instructions for Use (IFU) needs to be updated

— Associated with 3 deaths.

Equiptrack clients had access to the data days before the FDA’s public notice.

Download the Report

7-17-2025_Abiomed_AIC_Early_Recall_Alert_Doc
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Abiomed Automated Impella Controller (AIC)
Abiomed Automated Impella Controller (AIC)
Abiomed Automated Impella Controller (AIC)
Abiomed Automated Impella Controller (AIC)

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