FDA MedWatch Safety AlertsOriginal article
Heart Pump Recall: Abiomed Removes Impella CP Sets with SmartAssist
RegulatorynegativeImpella CPNegative
AI Analysis
Summary
Abiomed issued a recall of specific Impella CP Sets with SmartAssist due to out-of-specification manufacturing that may cause low purge pressure events during use.
Outcome Details
Product recall of Impella CP Sets with SmartAssist due to out-of-specification components; use may result in low purge pressure events
Importance:7/10
Sentiment:
-0.80
recallmedical devicesafety issueFDA MedWatch
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Published by FDA MedWatch Safety Alerts on July 2, 2026 4:00 AM