FDAHealthJuly 28, 2025
VANTIVE US HEALTHCARE LLC — PrisMax V3 control Unit-US, Hemodialysis Delivery System, Product Code 955724
⚠️ 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
Is this relevant to me?
- Geography
- Unknown
- Source agency
- FDA
- Category
- Health
- Published
- July 28, 2025
Worldwide
What's affected?
- Product
- PrisMax V3 control Unit-US, Hemodialysis Delivery System, Product Code 955724
- Lot code
- UDI 07332414126018, All serial numbers
Additional details
UDI 07332414126018, All serial numbers
What should I do?
Recommended action
Class II recall. Voluntary: Firm initiated Quantity affected: 2449 units.
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