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PRISMAFLEX SET recallZ-1228-2026 · Vantive US Healthcare LLC · initiated Jan 6, 2026

Open, Classified

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Vantive US Healthcare LLC or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

There is a potential dislodgement of the Prismaflex Set deaeration chamber from the Prismaflex Control Unit.

FDA root cause category: Component design/selection

What the company is doing

Vantive issued an Urgent Medical Device Correction notice to its consignees on 01/06/2026 via USPS first class mail. The notice explained the issue, hazard involved, and requested the following: 1. You may continue to perform therapy using the Prismaflex sets listed above. Please monitor the deaeration chamber during therapy to ensure it remains in an upright position within the holder. 2. Vantive is aware of customers who have experienced this issue and attempted to further secure the deaeration chamber in an upright position. If attempting to secure the deaeration chamber in an upright position, please consider the following: . Ensure 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, check if air is present. If there is no air present, check if the deaeration chamber is dislodged from the holder and ensure there are no clots present. 1. If no dislodgement, please follow the operator s manual instructions for Air in Blood alarm. 2. In case of dislodgement with clotting, follow the associated instructions within the Prismaflex Control Unit operator s manual to stop the therapy and replace the set. 3. Only in case of dislodgement without clotting or any other alarms, if the chamber is secured in an upright position, follow the associated instructions within the Prismaflex Control Unit operator s manual to proceed with treatment. Facilities who further distributed the products were directed to notify those departments or facilities. Dealers, wholesalers, distributor/resellers, or original equipment manufacturers (OEM) who further distributed the products were directed to notify their customers. For general questions regarding this communication, please contact Vantive Customer Care at 833-542-CRRT (2778). Vantive Customer Care is available 24 hours a day, seven days a week.

Recall details

Recall number
Z-1228-2026
Status
Open, Classified
Initiated by the company
Jan 6, 2026
Posted by the FDA
Feb 2, 2026
Recalling firm
Vantive US Healthcare LLC
Quantity
137,576 units
Product code
KDI
FDA submissions
K080519
Distribution
US Nationwide distribution.

Product description

PRISMAFLEX M150 SET, Product Code 109990; Dialyzer, High Permeability With Or Without Sealed Dialysate System

Code information (models, lots, serial numbers)

UDI/DI 07332414090005, All lots including and manufactured after 24F0100CA

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

Product lines

Other products in the same recall event

The FDA groups related products into one recall event (event 98180).

Sources and updates

How recalls are matched to devices · Editorial policy · Report an error on this page