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Abiomed, Inc. recalls Impella CP Set with SmartAssist. Product Codes: 1000080, 1000851, 0048-0014, 0048-0024-JP.
Recalled June 24, 2026 · FDA recall Z-2457-2026 · Abiomed
Hazard
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. · FDA Class I
Units
10 units
Sold at
US distribution to GA, IA, NE, PA, TX, WA, WI. International distribution to Czech Republic, Norway, and Japan
Description
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.
Product
Impella CP Set with SmartAssist. Product Codes: 1000080, 1000851, 0048-0014, 0048-0024-JP.
Manufacturer(s)
Abiomed, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →