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.

VANTIVE US HEALTHCARE LLC Medical Device Recall: PrisMax V3 control Unit-US, Hemodialysis Delivery System, Product Code 955724 | SafeCheck