FDA recall record · openFDA

VANTIVE US HEALTHCARE LLC

12 FDA recalls on record (2025–2026) — 12 device. 12 still ongoing.

Class I (most serious)

Class II

Class III

ongoing

How to read this. A recall count is not a quality verdict — large manufacturers recall more simply by volume, and a voluntary recall is the safety system working as intended. The signal to weight is the Class I count (the FDA's most-serious tier — reasonable probability of serious harm or death) and whether recalls are still ongoing. Most recalls are Class II/III. "Ongoing" reflects openFDA's last-published status — device recalls often stay marked ongoing long after they're resolved in practice; confirm current status at the FDA.

Most common reasons

There is a potential dislodgement of the Prismaflex Set deaeration chamber from the Prismaflex Control Unit. 8

Low deaeration chamber level at post priming tests may lead to PrisMax System alarm T2309: Air Detected in Prime resulti 1

Thermax System may be unable to detect the presence of a bag on the Thermax Blood Warmer Unit leading to difficulty sett 1

Vantive has identified a software defect within the Sharesource Claria software, which may cause a patient s updated pre 1

Unexpected PrisMax System alarm T0830: Blood Leak Detected, when no blood leak is present, or difficulty normalizing the 1

Recalls

PRIMSAFLEX M100 SET, Product Code 106697; Dialyzer, High Permeability With Or Without Sealed Dialysate System Class II 2026-01-06 PRISMAFLEX ST100 SET US, Product Code 107636US; Dialyzer, High Permeability With Or Without Sealed Dialysate System Class II 2026-01-06 OXIRIS SET, Product Code 112016; Dialyzer, High Permeability With Or Without Sealed Dialysate System Class II 2026-01-06 PRISMAFLEX M150 SET, Product Code 109990; Dialyzer, High Permeability With Or Without Sealed Dialysate System Class II 2026-01-06 PRISMAFLEX TPE2000 SET, Product Code 114093; Dialyzer, High Permeability With Or Without Sealed Dialysate System Class II 2026-01-06 PRISMAFLEX HF1000 SET, Product Code 107140; Dialyzer, High Permeability With Or Without Sealed Dialysate System Class II 2026-01-06 PRISMAFLEX ST150 SET US, Product Code 107640US; Dialyzer, High Permeability With Or Without Sealed Dialysate System Class II 2026-01-06 PRISMAFLEX HF1000 SET, Product Code 107142; Dialyzer, High Permeability With Or Without Sealed Dialysate System Class II 2026-01-06 PrisMax V2-US, Hemodialysis Delivery System, Product Codes: 955626, 955558, 955627, 955701 Class II 2025-07-28 TherMax Blood Warmer Unit-US, PrisMax Accessory, Product Codes: 955630, 955515, 955702, 955631 Class II 2025-07-28 Sharesource Connectivity Platform for Use with Homechoice Claria Product Code 5CGM01 software versions 7.13.3 (China Class II 2025-08-28 PrisMax V3 control Unit-US, Hemodialysis Delivery System, Product Code 955724 Class II 2025-07-28

RECORDED — these are the FDA's published recall enforcement records (openFDA). Recalls are listed under the exact firm name as filed; a large manufacturer may also file under name variants, so this may not be the company's complete cross-variant record — confirm at the FDA recall database. This page informs and routes; it is not medical advice or a verdict on the company.

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