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VANTIVE US HEALTHCARE Recalls
12 recalls on record · September 3, 2025 to February 11, 2026 · Medical Devices
Recalls by year
25
26
Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
February 11, 2026Medical DevicesFDA
VANTIVE US HEALTHCARE LLC recalls PRISMAFLEX TPE2000 SET, Product Code 114093; Dialyzer, High Permeability With Or Without Sealed Dialysate System
Hazard: There is a potential dislodgement of the Prismaflex Set deaeration chamber from the Prismaflex Control Unit.
February 11, 2026Medical DevicesFDA
VANTIVE US HEALTHCARE LLC recalls PRISMAFLEX HF1000 SET, Product Code 107142; Dialyzer, High Permeability With Or Without Sealed Dialysate System
Hazard: There is a potential dislodgement of the Prismaflex Set deaeration chamber from the Prismaflex Control Unit.
February 11, 2026Medical DevicesFDA
VANTIVE US HEALTHCARE LLC recalls PRISMAFLEX HF1000 SET, Product Code 107140; Dialyzer, High Permeability With Or Without Sealed Dialysate System
Hazard: There is a potential dislodgement of the Prismaflex Set deaeration chamber from the Prismaflex Control Unit.
February 11, 2026Medical DevicesFDA
VANTIVE US HEALTHCARE LLC recalls PRISMAFLEX M150 SET, Product Code 109990; Dialyzer, High Permeability With Or Without Sealed Dialysate System
Hazard: There is a potential dislodgement of the Prismaflex Set deaeration chamber from the Prismaflex Control Unit.
February 11, 2026Medical DevicesFDA
VANTIVE US HEALTHCARE LLC recalls PRIMSAFLEX M100 SET, Product Code 106697; Dialyzer, High Permeability With Or Without Sealed Dialysate System
Hazard: There is a potential dislodgement of the Prismaflex Set deaeration chamber from the Prismaflex Control Unit.
February 11, 2026Medical DevicesFDA
VANTIVE US HEALTHCARE LLC recalls OXIRIS SET, Product Code 112016; Dialyzer, High Permeability With Or Without Sealed Dialysate System
Hazard: There is a potential dislodgement of the Prismaflex Set deaeration chamber from the Prismaflex Control Unit.
February 11, 2026Medical DevicesFDA
VANTIVE US HEALTHCARE LLC recalls PRISMAFLEX ST150 SET US, Product Code 107640US; Dialyzer, High Permeability With Or Without Sealed Dialysate System
Hazard: There is a potential dislodgement of the Prismaflex Set deaeration chamber from the Prismaflex Control Unit.
February 11, 2026Medical DevicesFDA
VANTIVE US HEALTHCARE LLC recalls PRISMAFLEX ST100 SET US, Product Code 107636US; Dialyzer, High Permeability With Or Without Sealed Dialysate System
Hazard: There is a potential dislodgement of the Prismaflex Set deaeration chamber from the Prismaflex Control Unit.
November 5, 2025Medical DevicesFDA
Vantive US Healthcare LLC recalls Sharesource Connectivity Platform for Use with Homechoice Claria Product Code 5CGM01 software versions 7.13.3 (China
Hazard: Vantive has identified a software defect within the Sharesource Claria software, which may cause a patient s updated prescription program settings to not be properly saved on the actual cycler that the patient is using to perform their therapy. As a result, the clinician may think that the patient is receiving the correct prescribed therapy because of what is erroneously displayed on the clinician's remote Sharesource application, when in fact the cycler that is with the patient is actually delivering an outdated and incorrect therapy.
September 3, 2025Medical DevicesFDA
VANTIVE US HEALTHCARE LLC recalls TherMax Blood Warmer Unit-US, PrisMax Accessory, Product Codes: 955630, 955515, 955702, 955631
Hazard: Thermax System may be unable to detect the presence of a bag on the Thermax Blood Warmer Unit leading to difficulty setting up therapy, or PrisMax System alarm T2284: Thermax Disposable Not Inserted
September 3, 2025Medical DevicesFDA
VANTIVE US HEALTHCARE LLC recalls PrisMax V3 control Unit-US, Hemodialysis Delivery System, Product Code 955724
Hazard: 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
September 3, 2025Medical DevicesFDA
VANTIVE US HEALTHCARE LLC recalls PrisMax V2-US, Hemodialysis Delivery System, Product Codes: 955626, 955558, 955627, 955701
Hazard: Low deaeration chamber level at post priming tests may lead to PrisMax System alarm T2309: Air Detected in Prime resulting in multiple additional priming cycles