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Heart Pump Recall

1 recall on record · Last recall: Jul 2, 2026

Safety Score

97/100

Excellent

Based on recall frequency and severity over the past 3 years, with older recalls weighted less.

Severity Breakdown

Class I — Serious
0
Class II — Moderate
0
Class III — Low Risk
0
Unclassified
1

Categories

MEDICATION

Recall Timeline

FDAJul 2, 2026

Heart Pump Recall: Abiomed Removes Impella CP Sets with SmartAssist

Specific Impella CP Sets are out of specification; use may result in low purge pressure events from the onset of the case

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