FDAHealthMay 18, 2026
Abiomed, Inc. — Impella CP Set with SmartAssist. Product Codes: 1000080, 1000851, 0048-0014, 0048-0024-JP.
⚠️ 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.
Is this relevant to me?
- Geography
- US, GA, IA, NE, PA, TX, WA, WI
- Source agency
- FDA
- Category
- Health
- Published
- May 18, 2026
US distribution to GA, IA, NE, PA, TX, WA, WI. International distribution to Czech Republic, Norway, and Japan
What's affected?
- Product
- Impella CP Set with SmartAssist. Product Codes: 1000080, 1000851, 0048-0014, 0048-0024-JP.
- Brand
- Abiomed, Inc.
- Lot code
- GTIN: 00813502012279. Product Codes (Serial Number): 1000080 (677223, 672986, 673252, 644591, 645428, 644314, 613525), 1000851 (636173), 0048-0014 (499250), 0048-0024-JP (661216).
Additional details
GTIN: 00813502012279. Product Codes (Serial Number): 1000080 (677223, 672986, 673252, 644591, 645428, 644314, 613525), 1000851 (636173), 0048-0014 (499250), 0048-0024-JP (661216).
What should I do?
Recommended action
Class I recall. Voluntary: Firm initiated Quantity affected: 10 units.
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