FDA Device recall Z-2438-2025
PrisMax V3 control Unit-US, Hemodialysis Delivery System, Product Code 955724
- FDA Device
- Class II
- ongoing
- Published 2025-09-03
On 2025-09-03 the FDA classified a Class II recall of PrisMax V3 control Unit-US, Hemodialysis Delivery System, Product Code 955724 by Vantive Us Healthcare, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2438-2025 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2025-07-28 |
| Published | 2025-09-03 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Vantive Us Healthcare |
| Distribution | n/a |
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
Identifiers
| code_info | UDI 07332414126018, All serial numbers |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2438-2025%22
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