← Every firm
Vantive Us Healthcare LLC FDA Recalls
12 recalls on file across devices, 0 of them Class I and 12 still open. This firm is not matched to a listed company.
Newest first
Class I is the FDA's most serious grade: a reasonable probability of serious harm or death.
| Product |
|---|
| PRISMAFLEX M150 SET, Product Code 109990; Dialyzer, High Permeability With Or Without Sealed Dialysate SystemClass IIJan 6, 2026There is a potential dislodgement of the Prismaflex Set deae |
| OXIRIS SET, Product Code 112016; Dialyzer, High Permeability With Or Without Sealed Dialysate SystemClass IIJan 6, 2026There is a potential dislodgement of the Prismaflex Set deae |
| PRIMSAFLEX M100 SET, Product Code 106697; Dialyzer, High Permeability With Or Without Sealed Dialysate SystemClass IIJan 6, 2026There is a potential dislodgement of the Prismaflex Set deae |
| PRISMAFLEX HF1000 SET, Product Code 107140; Dialyzer, High Permeability With Or Without Sealed Dialysate SystemClass IIJan 6, 2026There is a potential dislodgement of the Prismaflex Set deae |
| PRISMAFLEX ST150 SET US, Product Code 107640US; Dialyzer, High Permeability With Or Without Sealed Dialysate SystemClass IIJan 6, 2026There is a potential dislodgement of the Prismaflex Set deae |
| PRISMAFLEX ST100 SET US, Product Code 107636US; Dialyzer, High Permeability With Or Without Sealed Dialysate SystemClass IIJan 6, 2026There is a potential dislodgement of the Prismaflex Set deae |
| PRISMAFLEX TPE2000 SET, Product Code 114093; Dialyzer, High Permeability With Or Without Sealed Dialysate SystemClass IIJan 6, 2026There is a potential dislodgement of the Prismaflex Set deae |
| PRISMAFLEX HF1000 SET, Product Code 107142; Dialyzer, High Permeability With Or Without Sealed Dialysate SystemClass IIJan 6, 2026There is a potential dislodgement of the Prismaflex Set deae |
| Sharesource Connectivity Platform for Use with Homechoice Claria Product Code 5CGM01 software versions 7.13.3 (ChinaClass IIAug 28, 2025Vantive has identified a software defect within the Sharesou |
| TherMax Blood Warmer Unit-US, PrisMax Accessory, Product Codes: 955630, 955515, 955702, 955631Class IIJul 28, 2025Thermax System may be unable to detect the presence of a bag |
| PrisMax V2-US, Hemodialysis Delivery System, Product Codes: 955626, 955558, 955627, 955701Class IIJul 28, 2025Low deaeration chamber level at post priming tests may lead |
| PrisMax V3 control Unit-US, Hemodialysis Delivery System, Product Code 955724Class IIJul 28, 2025Unexpected PrisMax System alarm T0830: Blood Leak Detected, |