Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
PrisMax V3 control Unit-US Recalled by VANTIVE US HEALTHCARE LLC Due to Unexpected PrisMax System alarm T0830: Blood Leak Detected,...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact VANTIVE US HEALTHCARE LLC directly.
Affected Products
PrisMax V3 control Unit-US, Hemodialysis Delivery System, Product Code 955724
Quantity: 2449 units
Why Was This Recalled?
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
Where Was This Sold?
Worldwide
About VANTIVE US HEALTHCARE LLC
VANTIVE US HEALTHCARE LLC has 11 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report