Hemodialysis Delivery System Blood Leak Detector False Alarms Recall
VANTIVE US HEALTHCARE recalls PrisMax V3 hemodialysis control units due to false blood leak detection alarms and detector normalization failures that could interfere with actual leak detection.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II recall of a hemodialysis delivery system with malfunctions affecting a critical safety feature. The source document contains no reports of patient injuries or hospitalizations. Per the severity rubric, FDA Class II recalls without reported hospitalization classify as High (score 3), given the risk-of-harm nature of a malfunctioning blood leak detector in life-sustaining hemodialysis equipment.
Plain-English summary
VANTIVE US HEALTHCARE LLC is recalling the PrisMax V3 control Unit-US, a hemodialysis delivery system (product code 955724). The recall encompasses approximately 2,449 units distributed worldwide, identified by UDI 07332414126018 with all serial numbers included.
The recalled devices may experience unexpected alarm T0830 indicating blood leak detection when no leak is actually present. Additionally, the devices may have difficulty properly normalizing the blood leak detector, resulting in alarms T1313 (BLD Normalize Failed), T0853 (Normalization Failed), or T1205 (BLD Self-Test Failure).
The blood leak detector is a critical safety feature in hemodialysis systems. Malfunctioning or false alarms could interfere with proper detection and response to actual blood leaks during patient treatment.
Healthcare facilities operating affected units should contact VANTIVE US HEALTHCARE LLC for device replacement or corrective action options.
The recalled product
- Product
- PrisMax V3 control Unit-US, Hemodialysis Delivery System, Product Code 955724
- Manufacturer
- VANTIVE US HEALTHCARE LLC
- Hazard
- false-alarm
- blood-leak-detector-failure
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.
Related recalls
Same category
- HighGE CARESCAPE Telemetry Server may lose patient ECG and oxygen saturation monitoring
FDA (Devices) · 2026-06-03
- HighPhilips Azurion and Allura Imaging Systems Recalled for Hard Drive Degradation
FDA (Devices) · 2026-06-03
- HighPhilips Allura Imaging Systems Hard Drive Degradation Affects Functionality
FDA (Devices) · 2026-06-03
- ModerateMedtronic Deep Brain Stimulation Pocket Adaptor Kits recalled for incorrect expiration dates
FDA (Devices) · 2026-06-03
- SevereMedline spinal injection kits recalled for quality and efficacy concerns
FDA (Devices) · 2026-06-03