Impella CP Set with SmartAssist
Abiomed is recalling Impella CP Sets with SmartAssist due to a risk of low purge pressure that may interrupt mechanical circulatory support.
Healthcare providers should review the urgent medical device correction letter provided by Abiomed and follow the updated instructions for managing purge pressure alarms. Contact Abiomed for further technical support or clinical guidance.
Why it was recalled
Abiomed is recalling the Impella CP Set with SmartAssist due to a risk of low purge pressure, which can lead to persistent alarms and the potential interruption or loss of mechanical circulatory support. This issue may cause serious adverse health consequences or death.
Is mine affected?
Check the model, lot, or serial number on the device or its packaging. Yours is affected if it matches one below.
Impella CP Set with SmartAssist. Product Codes: 1000080, 1000851, 0048-0014, 0048-0024-JP.
- UPC
- 00813502012279
- Recall #
- Z-2457-2026
Where it was sold
Distributed in Georgia, Iowa, Nebraska, Pennsylvania, Texas, Washington, and Wisconsin.
Official source
Other recent recalls from Abiomed, Inc.
Editorial summary by Recall Canary · last updated 2026-06-19 · primary source: U.S. Food and Drug Administration · severity reflects the agency's published classification