Vantive

Vantive US Healthcare is recalling certain Prismaflex TPE2000 dialysis sets because the deaeration chamber may detach from the Prismaflex Control Unit during use. This could interrupt dialysis treatment. The recall affects units manufactured on or after June 2024.

The deaeration chamber in certain Prismaflex HF1000 dialyzer sets may become loose or detached from the Prismaflex Control Unit during use. This could affect the proper function of the dialysis equipment. The recall affects units manufactured on or after lot 24F0094CA.

Vantive US Healthcare is recalling Prismaflex HF1000 dialyzer sets because the deaeration chamber may come loose from the Prismaflex Control Unit during use. This affects units manufactured on or after lot 24G0034CA. No injuries have been reported.

Vantive US Healthcare is recalling Prismaflex M150 dialyzer sets because the deaeration chamber may separate from the Prismaflex Control Unit during use. This could disrupt dialysis treatment. The recall affects units manufactured on or after June 24, 2024.

Vantive US Healthcare is recalling Prismaflex M100 dialyzer sets because the deaeration chamber may separate from the control unit during use. This affects units manufactured on or after lot 24F0077CA. The FDA has classified this as a Class II recall.

Vantive US Healthcare is recalling certain OXIRIS dialyzer sets because a part called the deaeration chamber may come loose from the Prismaflex Control Unit during use. This could interrupt dialysis treatment. No injuries have been reported so far.

Vantive US Healthcare has recalled Prismaflex ST150 dialyzer sets because the deaeration chamber may become loose and detach from the control unit during use. This affects units manufactured on or after June 24, 2025. No injuries have been reported.

The deaeration chamber in certain Vantive Prismaflex ST100 dialyzer sets may detach from the control unit during use. This could interrupt treatment. The recall affects units manufactured on or after lot 24G0072.

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.