fda_recall · device_recall · critical

Abiomed, Inc. — Class I recall: Abiomed Impella CP Set with SmartAssist (10th Generation) containing affected 14…

Event date
2026-07-01 00:00:00Z
Observed
2026-07-09 22:51:52Z
Source ID
Z-2601-2026
Payload hash
2da72b3e5b44104034dc3a28

Summary

Potential for thrombus formation during prolonged use of the introducer. Status: Ongoing.

Informational only. Not legal, financial, or medical advice.