FDA-Device2026-06-24Class IPROCESSING DEFECT
Abiomed Impella CP Set with SmartAssist recalled for mechanical support interruption risk
Abiomed Impella CP Set recalled for support interruption risk
Abiomed's Impella CP Set with SmartAssist may experience low purge pressure issues that trigger repeated alarms. In some cases, this malfunction can interrupt or stop the device's mechanical heart support function.
- If you use this device, contact Abiomed or your healthcare provider immediately about your specific serial number.
- Do not ignore persistent low purge pressure alarms — report them to your medical team right away.
- Check the device serial number against the affected list (1000080, 1000851, 0048-0014, 0048-0024-JP).
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.
Sold states
US distribution to GA, IA, NE, PA, TX, WA, WI. International distribution to Czech Republic, Norway, and Japan
Affected count
10 units
Manufactured in
22 Cherry Hill Dr, Danvers, MA, United States
Products
Impella CP Set with SmartAssist. Product Codes: 1000080, 1000851, 0048-0014, 0048-0024-JP.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2457-2026More Abiomed, Inc. recalls
- FDA-Device2026-06-24Abiomed Impella Controller recalled for software error risk
- FDA-Device2026-06-03Abiomed Impella Controller recalled for alarm failures and cassette misalignment
- FDA-Device2026-06-03Abiomed Impella Controller recalled for hardware defects affecting motor control and device function
- FDA-Device2026-04-08Abiomed Impella Controller recalled for delayed alarm display with Impella 5.5 pumps
- FDA-Device2026-04-08Abiomed Impella Pump Set purge cassettes recalled for increased leak risk
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