---
title: "PrisMax V3 control Unit-US, Hemodialysis Delivery System, Product Code 955724 — FDA record Z-2438-2025 | Is It on Recall"
description: "Unexpected PrisMax System alarm T0830: Blood Leak Detected, when no blood leak is present, or difficulty normalizing the Blood Leak Detector (BLD) leading to Pr"
url: https://isitonrecall.com/recall/fda-device-z-2438-2025-prismax-v3-control-unit-us-hemodialysis-delivery-system-product-code-955724/
updated: 2026-10-01
site: "Is It on Recall"
language: en
---

[Recall archive](https://isitonrecall.com/archives/) / FDA device enforcement

# PrisMax V3 control Unit-US, Hemodialysis Delivery System, Product Code 955724 — FDA record Z-2438-2025

Reported ongoing

Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.

Source date Jul 28, 2025. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.

Archive changed Oct 1, 2026. USDA FSIS records are unavailable; [check FSIS directly](https://www.fsis.usda.gov/recalls). [Source coverage and dates](https://isitonrecall.com/sources/).

## What the record says

- **Product**: PrisMax V3 control Unit-US, Hemodialysis Delivery System, Product Code 955724
- **Reason**: 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
- **Classification**: Class II
- **Recalling firm**: VANTIVE US HEALTHCARE LLC
- **Quantity**: 2449 units
- **Agency-reported status**: Ongoing
- **Source record identifier**: Z-2438-2025

[Open the official record](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-2438-2025%22)

[What the recall classes mean](https://isitonrecall.com/guides/recall-classes/). Classification is an agency assessment, not individual medical advice.

## Lot and product identifiers

| Label field | Details supplied by the agency |
| --- | --- |
| Lot, code or applicability | UDI 07332414126018, All serial numbers |

Match all identifying details in the current notice. A brand name alone is not enough.

## Distribution

Worldwide

No US distribution state could be established from this record. Check the official notice.

## Dates in the source

- **Report date**: Sep 3, 2025
- **Recall initiation date**: Jul 28, 2025
- **Center classification date**: Aug 26, 2025

FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.

## What to do next

Read the official notice for the action that applies to your exact product.

[Read the current instructions](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-2438-2025%22)

## Related records

[Medical devices records](https://isitonrecall.com/category/medical-devices/) [VANTIVE US HEALTHCARE LLC records](https://isitonrecall.com/brand/vantive-us-healthcare-llc/)