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

