PrisMax V3 control Unit-US — Class II medical device recall Z-2438-2025
Ongoing recall by VANTIVE US HEALTHCARE LLC, reported 2025-09-03. Unexpected PrisMax System alarm T0830: Blood Leak Detected, when no blood leak is present, or difficulty norma
| Recall number | Z-2438-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | VANTIVE US HEALTHCARE LLC, Deerfield, IL, United States |
| Recall initiated | 2025-07-28 |
| Classified | 2025-08-26 |
| Reported by FDA | 2025-09-03 |
| Quantity | 2,449 units |
| Reason classes | packaging |
| UPC / GTIN / UDI-DI | 07332414126018 |
Product
PrisMax V3 control Unit-US, Hemodialysis Delivery System, Product Code 955724
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
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2438-2025. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.