PrismaFlex (dialysis system)

2026: Detection of a defect due to which the device suddenly turned off

On January 14, 2026, the U.S. Food and Drug Administration (FDA) reported a problem with a set of tubes for Vantive dialysis systems ( formerly a division of Baxter). The defect can lead to interruption of therapy and harm to the health of patients.

We are talking about kits designed for use with PrismaFlex control units. The tubes serve to provide continuous fluid regulation and renal replacement therapy, blood purification, or therapeutic plasma exchange.

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Фото: baxterhealthcare.co.uk

According to Vantive, the deaeration chambers in the kit can be displaced from the PrismaFlex control unit holder. This problem does not affect the PrisMax units, since such devices have a different mounting design. Changing the position of the deaeration chamber can trigger the "Air in the blood" alarm: the error manifests itself both during the filling phase before the start of therapy, and during the therapy itself. As a result, delays or interruptions of the treatment course may occur.

As of December 17, 2025, Vantive did not report any serious injuries or deaths related to the problem described. Medical facilities may continue to use the affected equipment, but care must be taken to ensure that the deaeration chamber remains upright inside the holder during therapy. If the PrismaFlex control unit issues an alarm, medical personnel should monitor the presence of air in the blood. When fixing the chamber in the vertical position, it is also necessary to take into account other points, such as the absence of bends in the tubes. Vantive has already sent letters to customers with updated recommendations for operating dialysis systems.^[1]

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