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 22:51:56Z
Source ID
Z-2602-2026
Payload hash
69c3e9dd3d2e961c9a96850d

Summary

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

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