The FDA has issued an early alert warning of a “potentially high-risk” device safety issue regarding the Prismaflex control units, manufactured by Vantive, noting that the sets may continue to be used with some precautions.

The control units are primarily used for continuous renal replacement therapy and other renal replacement therapies in critically ill patients with acute renal failure.

According to the alert, Vantive has been made aware of reports of the control units’ deaeration chambers potentially dislodging from the control unit and falling out of the proper upright position.

The chamber’s dislodging could result in an “Air in Blood” alarm during the priming phase prior to the initiation of therapy or during therapy.

Importantly, the alarm could lead to delays or interruptions of therapy, in addition to blood loss due to clotting and failure to return blood manually, according to the alert.

No serious injuries or deaths had been reported as of December 17, 2025, and the FDA notes that users may continue to perform therapy using affected Prismaflex sets.

“Vantive is aware of customers who have experienced this issue and attempted to further secure the deaeration chamber in an upright position,” the alert explains.

Users should “monitor the deaeration chamber during therapy to ensure it remains in an upright position within the holder,” the FDA advises.

Should a repositioning to an upright position be necessary, users should make sure there are no kinks in the tubing and that the deaeration chamber remains visible.

If the Prismaflex control unit issues an “Air in Blood” alarm, users should check to determine if air is indeed present, and if not, check to see if the deaeration chamber has been dislodged from its holder, while making sure no clots are present. 

In the absence of dislodgement, the operator’s manual instructions for an “Air in Blood” alarm should be followed.

If dislodgement has occurred with clotting, the instructions for those circumstances in the Prismaflex control unit operator’s manual should be followed to discontinue the therapy and replace the set.

Only when dislodgement occurs without clotting or any other alarms and the chamber is secured in an upright position the corresponding instructions within the Prismaflex control unit operator’s manual be followed to proceed with treatment.

Of note, there have not been similar reports with the PrisMax control units, which feature a different deaeration chamber holder design.

The specific product information of affected devices is detailed on the FDA Alert page.