fda_recall · device_recall · critical
Abiomed, Inc. — Class I recall: Impella CP Set with SmartAssist. Product Codes: 1000080, 1000851, 0048-0014, 004…
- Event date
- 2026-06-24 00:00:00Z
- Observed
- 2026-07-09 22:51:58Z
- Source ID
- Z-2457-2026
- Payload hash
- f8d6e53d6f8a5979360290e0…
Summary
Exposure to the low purge pressure occurrence may result in persistent low purge pressure alarms and, in some cases, interruption or loss of mechanical circulatory support. Status: Ongoing.
Entities
Informational only. Not legal, financial, or medical advice.