Abiomed, Inc. recalls Impella CP Set with SmartAssist. Product Codes: 1000080
- Recalling company
- Abiomed, Inc.
- Product
- Impella CP Set with SmartAssist. Product Codes: 1000080, 1000851, 0048-0014, 0048-0024-JP.
- Reason
- 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.
- Classification
- Class I – a reasonable probability that use will cause serious adverse health consequences or death
- Recall date
- May 18, 2026
- Reported
- Jun 24, 2026
- Distribution
- US distribution to GA, IA, NE, PA, TX, WA, WI. International distribution to Czech Republic, Norway, and Japan
- Status
- Ongoing
- Quantity
- 10 units
- Lot / codes
- GTIN: 00813502012279. Product Codes (Serial Number): 1000080 (677223, 672986, 673252, 644591, 645428, 644314, 613525), 1000851 (636173), 0048-0014 (499250), 0048-0024-JP (661216).
- Company location
- Danvers, MA
- Recall type
- Voluntary: Firm initiated
- Recall number
- Z-2457-2026
- Agency
- U.S. Food and Drug Administration (FDA)
View official FDA notice ↗ Search recall number Z-2457-2026 in the FDA Enforcement Report. Also see FDA recall press releases.
If you use this product, check the lot, NDC or model number against the official notice and follow its instructions. Do not stop a prescribed medicine or remove a medical device without talking to your doctor or pharmacist. Report problems to FDA MedWatch. FoodRecallNow summarizes public FDA data and is not medical advice.