Impella CP Set with SmartAssist. Product Codes: 1000080, 1000851, 0048-0014, 0048-0024-JP.
Class I
- Recalling firm
- Abiomed, Inc.
- Reason for recall
- 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.
- Distribution pattern
- US distribution to GA, IA, NE, PA, TX, WA, WI. International distribution to Czech Republic, Norway, and Japan
- State
- MA
- Status
- Ongoing
- Recall number
- Z-2457-2026
- Recall initiated
- May 18, 2026
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