Class II

Medical Device Recall: Impella 5.5 with SmartAssist¿ S2, Impella 5.5 with SmartAssist S2 Set, AU.

Abiomed, Inc. · December 4, 2025

Reason for Recall

Device packaged in incorrect outer box carton.

Distribution

International distribution to the country of Australia.

Quantity Affected

2 units

Source: FDA (openFDA Device Enforcement)

Recall number: Z-1030-2026

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.