Vantive updates instructions after dialysis system tubing issue

The FDA issued a notice related to updated instructions for the Vantive Prismaflex control units after reports of a potential tubing issue.

Vantive, the former kidney care unit of Baxter, issued a letter on Jan. 6 informing customers of the updated instructions. The FDA said it became aware of the “potentially high-risk device issue” related to the Prismaflex tubing sets. These sets, used with Prismaflex control units or PrisMax control units, help provide continuous fluid management and renal replacement therapies, blood purification or therapeutic plasma exchange.

According to Vantive, the Prismaflex set deaeration chambers may dislodge from the Prismaflex control unit. This issue does not affect PrisMax control units, as those devices have a different deaeration chamber holder design. A dislodged deaeration chamber may lead to an “Air in Blood” alarm on the Prismaflex control unit. The alarm may occur during the priming phase prior to initiating therapy or during therapy. This may result in delays or interruptions to therapy and blood loss due to clotting and failure to return blood manually.

As of Dec. 17, 2025, Vantive reports no serious injuries or deaths related to the issue.

Vantive told customers to monitor the deaeration chamber during therapy to ensure it remains in an upright position within the holder. They may continue to perform therapy using affected sets.

Other steps to consider when securing the chamber in an upright position include ensuring no kinks appear in the tubing and the deaeration chamber remains visible. If the unit issues an “Air in Blood” alarm, users should check for the presence of air. If they see no air present, they should check for the dislodging of the deaeration chamber.

List of affected devices: