Recall Atlas

Vantive US Healthcare recalls

5 official recalls and safety alerts involving Vantive US Healthcare since 2025-09, from FDA · Device. Newest first. Check the official notice for exact models and batch codes.

This list only includes recalls Recall Atlas has collected since 2021-10. A product not listed here may still be affected; check with Vantive US Healthcare or the relevant agency.

  1. 2026-02-11
  2. US
    Drugs & medicalClass II

    VANTIVE US HEALTHCARE LLC recalls 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.

    FDA · DeviceVANTIVE US HEALTHCARE LLCUS Nationwide distribution.Official notice →
  3. 2025-11-05
  4. US
    Drugs & medicalClass II

    Vantive US Healthcare LLC recalls Sharesource Connectivity Platform for Use with Homechoice Claria Product Code 5CGM01 software versions 7.13.3 (China), 8.13.2 (APAC and…

    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…

    FDA · DeviceVantive US Healthcare LLCWorldwide distribution - US Nationwide and the countries of Australia, Hong…Official notice →
  5. 2025-09-03
  6. US
    Drugs & medicalClass II

    VANTIVE US HEALTHCARE LLC recalls TherMax Blood Warmer Unit-US, PrisMax Accessory, Product Codes: 955630, 955515, 955702, 955631

    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

    FDA · DeviceVANTIVE US HEALTHCARE LLCWorldwideOfficial notice →
  7. US
    Drugs & medicalClass II

    VANTIVE US HEALTHCARE LLC recalls 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:…

    FDA · DeviceVANTIVE US HEALTHCARE LLCWorldwideOfficial notice →
  8. US
    Drugs & medicalClass II

    VANTIVE US HEALTHCARE LLC recalls 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

    FDA · DeviceVANTIVE US HEALTHCARE LLCWorldwideOfficial notice →