Dialysis control units recalled over false blood leak detection alarms
PrisMax V3 Control Units are recalled because of unexpected blood leak alarms when no leak is present, or difficulty normalizing the blood leak detector. 2,449 units are affected.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: Rubric level 2 covers precautionary recalls; the stated consequence is false or failed alarms rather than any described patient harm.
Plain-English summary
The PrisMax V3 Control Unit-US Hemodialysis Delivery System, product code 955724, UDI 07332414126018, is being recalled across all serial numbers. The recall covers 2,449 units distributed worldwide.
The system may raise the unexpected alarm T0830, Blood Leak Detected, when no blood leak is present, or there may be difficulty normalizing the Blood Leak Detector, leading to alarms T1313 BLD Normalize Failed, T0853 Normalization Failed or T1205 BLD Self-Test Failure. The FDA classified the action as Class II. The notice does not describe a patient consequence beyond the alarms.
Dialysis units operating these systems should follow the manufacturer's instructions for handling the alarms and for any corrective action.
The recalled product
- Product
- PrisMax V3 control Unit-US, Hemodialysis Delivery System, Product Code 955724
- Manufacturer
- VANTIVE US HEALTHCARE LLC
- Category
- Medical Device — Dialysis
- Affected units
- 2,449
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- UDI 07332414126018
- All serial numbers
Distribution
Distribution scope not specified by the agency.
Part of a larger recall action
This product is one of 3 recalled by VANTIVE US HEALTHCARE LLC under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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