Class II

Medical Device Recall: PrisMax V3 control Unit-US, Hemodialysis Delivery System, Product Code 955724

VANTIVE US HEALTHCARE LLC · July 28, 2025

Reason for Recall

Unexpected PrisMax System alarm T0830: Blood Leak Detected, when no blood leak is present, or difficulty normalizing the Blood Leak Detector (BLD) leading to PrisMax System alarms T1313: BLD Normalize Failed, T0853: Normalization Failed, or T1205: BLD Self-Test Failure

Distribution

Worldwide

Quantity Affected

2449 units

Source: FDA (openFDA Device Enforcement)

Recall number: Z-2438-2025

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.