FDA-Device2026-06-24Class IPROCESSING DEFECT
Abiomed Impella CP Set with SmartAssist recalled for mechanical support interruption risk
What this means
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).
The agency's original wording
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.
Intended for
Adults
Illnesses reported
None reported
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 recalls
- FDA-Device2026-07-22Abiomed Introducer Kit 23 Fr recalled for potential sheath leakage risk
- FDA-Device2026-07-22Abiomed Impella CP Smart Assist Set recalled for introducer sheath leakage risk
- FDA-Device2026-07-22Abiomed Intro Kit heart pump introducer recalled for potential fluid leakage risk
- FDA-Device2026-07-22Abiomed Impella CP heart pump recalled for introducer sheath leakage risk
- FDA-Device2026-07-22Abiomed Impella 5.5 Smart Assist Set recalled for introducer sheath leakage risk
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