Vantive US Healthcare LLC
FDA adverse event reports naming Vantive US Healthcare LLC as the device manufacturer, with recall history from the live FDA recall database. Reporter-supplied name as filed: VANTIVE US HEALTHCARE LLC.
- Total reports
- 5,607
- Deaths
- 41
- Injuries
- 1,324
- Malfunctions
- 4,242
Reports per year
Source: FDA adverse event reports by year received, 2024–2026. Reporting paused during the 2026 MAUDE-to-AEMS transition and has since resumed.
Top device categories
- Set, Administration, For Peritoneal Dialysis, DisposableKDJ2,721
- Dialyzer, High Permeability With Or Without Sealed Dialysate SystemKDI1,545
- System, Peritoneal, Automatic DeliveryFKX1,039
- Dialyzer, Capillary, Hollow FiberFJI170
- Separator For Therapeutic Purposes, Membrane Automated Blood Cell/PlasmaMDP59
- Subsystem, Water PurificationFIP50
- Set, Tubing, Blood, With And Without Anti-Regurgitation ValveFJK12
- Catheter, Hemodialysis, Non-ImplantedMPB4
- System, Hemodialysis, Remote AccessoriesMON3
- Hemodialyzer With Expanded Solute Removal ProfileQAX2
Recent recalls
- 2026-02-02Open, ClassifiedComponent design/selection
PRISMAFLEX ST100 SET US, Product Code 107636US; Dialyzer, High Permeability With Or Without Sealed Dialysate System
There is a potential dislodgement of the Prismaflex Set deaeration chamber from the Prismaflex Control Unit.
- 2026-02-02Open, ClassifiedComponent design/selection
PRISMAFLEX ST150 SET US, Product Code 107640US; Dialyzer, High Permeability With Or Without Sealed Dialysate System
There is a potential dislodgement of the Prismaflex Set deaeration chamber from the Prismaflex Control Unit.
- 2026-02-02Open, ClassifiedComponent design/selection
OXIRIS SET, Product Code 112016; Dialyzer, High Permeability With Or Without Sealed Dialysate System
There is a potential dislodgement of the Prismaflex Set deaeration chamber from the Prismaflex Control Unit.
- 2026-02-02Open, ClassifiedComponent design/selection
PRIMSAFLEX M100 SET, Product Code 106697; Dialyzer, High Permeability With Or Without Sealed Dialysate System
There is a potential dislodgement of the Prismaflex Set deaeration chamber from the Prismaflex Control Unit.
- 2026-02-02Open, ClassifiedComponent design/selection
PRISMAFLEX M150 SET, Product Code 109990; Dialyzer, High Permeability With Or Without Sealed Dialysate System
There is a potential dislodgement of the Prismaflex Set deaeration chamber from the Prismaflex Control Unit.
- 2026-02-02Open, ClassifiedComponent design/selection
PRISMAFLEX HF1000 SET, Product Code 107140; Dialyzer, High Permeability With Or Without Sealed Dialysate System
There is a potential dislodgement of the Prismaflex Set deaeration chamber from the Prismaflex Control Unit.
- 2026-02-02Open, ClassifiedComponent design/selection
PRISMAFLEX HF1000 SET, Product Code 107142; Dialyzer, High Permeability With Or Without Sealed Dialysate System
There is a potential dislodgement of the Prismaflex Set deaeration chamber from the Prismaflex Control Unit.
- 2026-02-02Open, ClassifiedComponent design/selection
PRISMAFLEX TPE2000 SET, Product Code 114093; Dialyzer, High Permeability With Or Without Sealed Dialysate System
There is a potential dislodgement of the Prismaflex Set deaeration chamber from the Prismaflex Control Unit.
- 2025-10-29Open, ClassifiedSoftware design
Sharesource Connectivity Platform for Use with Homechoice Claria Product Code 5CGM01 software versions 7.13.3 (China), 8.13.2 (APAC and Korea), and 8.13.4 (US, EMEA, and LATAM)
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.
- 2025-08-26Open, ClassifiedUnder Investigation by firm
PrisMax V2-US, Hemodialysis Delivery System, Product Codes: 955626, 955558, 955627, 955701
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
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