FDA MedWatch Safety AlertsOriginal article
Early Alert: Heart Pump Controller Issue from Abiomed
RegulatoryImpella ControllerNegative
AI Analysis
Summary
Abiomed is removing certain Impella Controller units following a retrospective review of servicing records that identified hardware, firmware, and/or software issues. This regulatory action represents a safety concern with the heart pump control device.
Outcome Details
Device removal due to hardware, firmware, and/or software issues identified in retrospective servicing records review
Importance:6/10
Sentiment:
-0.70
device safetyproduct recallFDA MedWatchcardiac deviceregulatory action
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Published by FDA MedWatch Safety Alerts on September 23, 2026 4:00 AM