Early Alert: Dialysis Tubing Set Issue from Vantive

U.S. Food and Drug Administration sent this bulletin at 01/14/2026 03:07 PM EST

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U.S. Food and Drug Administration, Center for Devices and Radiological Health

Early Alert: Dialysis Tubing Set Issue from Vantive

The FDA is aware that Vantive has issued a letter informing affected customers that Prismaflex Control Units have updated use instructions. Vantive stated that Prismaflex Set deaeration chambers may dislodge from the Prismaflex Control Unit. A dislodged deaeration chamber may lead to an “Air in Blood” alarm on the Prismaflex Control Unit. This issue does not affect PrisMax Control Units, as these devices have a different deaeration chamber holder design.

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Questions?

Customers in the U.S. with questions about this Early Alert communication should contact Vantive at 833-542-2778.

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