Class I

Medical Device Recall: Impella CP Set with SmartAssist. Product Codes: 1000080, 1000851, 0048-0014, 0048-0024-JP.

Abiomed, Inc. · May 18, 2026

Reason for Recall

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.

Distribution

US distribution to GA, IA, NE, PA, TX, WA, WI. International distribution to Czech Republic, Norway, and Japan

States Affected

GA, IA, NE, PA, TX, WA, WI

Quantity Affected

10 units

Source: FDA (openFDA Device Enforcement)

Recall number: Z-2457-2026

Status: ongoing

SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.

Abiomed, Inc. Medical Device Recall: Impella CP Set with SmartAssist. Product Codes: 1000080, 1000851, 0048-0014, 0048-0024-JP. | SafeCheck