Vantive Healthcare recalls PrisMax V3 control units with product code 95572: Unexpected blood leak alarms may occur without actual blood leaks, risking dialysis safety. Affected units have specific serial numbers.
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
Vantive Healthcare is recalling PrisMax V3 control units for hemodialysis that may trigger false blood leak alarms. This could lead to system errors during dialysis treatments if not addressed.
The system may incorrectly alarm for blood leaks when none exist, causing the dialysis machine to stop treatment or display errors. This could lead to interrupted dialysis sessions or incorrect system responses.
Hemodialysis patients using the PrisMax V3 control units with product code 955724 are most at risk. Patients should check if their unit has the affected serial numbers.
Check for product code 955724 on the PrisMax V3 control unit. All units with serial numbers starting with 07332414126018 are affected.
If your PrisMax V3 control unit alarms for blood leaks without actual blood leaks, stop using it immediately.
The PrisMax V3 control units may trigger false blood leak alarms, which could cause the dialysis system to stop treatment or display errors.
Check for product code 955724 and serial numbers starting with 07332414126018 on the control unit.
If your unit alarms for blood leaks without actual blood leaks, stop using it immediately. Contact Vantive Healthcare for further instructions.
We’ve drafted a message you can send Vantive Healthcare to request your refund or repair — edit it as you like.
Subject: Recall Z-2438-2025 — Vantive Healthcare Vantive Healthcare Hello, I own a Vantive Healthcare that is covered by recall Z-2438-2025 from Vantive Healthcare. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
