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PrisMax V2-US, Hemodialysis Delivery System, Product Codes:… recallZ-2437-2025 · Vantive US Healthcare LLC · initiated Jul 28, 2025

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

Low deaeration chamber level at post priming tests may lead to PrisMax System alarm T2309: Air Detected in Prime resulting in multiple additional priming cycles

FDA root cause category: Under Investigation by firm

What the company is doing

Vantive issued an Urgent Medical Device Correction notice to it consignees on 0728/2025 via USPS first class mail. The notice explained the issues with the devices, hazard involved, and requested the following: Actions to be Taken by Customers 1. Operators may continue to safely use the PrisMax Systems and TherMax Blood Warmer Units per the associated Operator s Manuals and on-screen instructions. If further assistance is required, please contact your local Vantive account representative. Please ensure that all operators of these devices are made aware of this Urgent Medical Device Correction notification. Vantive recommends that a copy of this notification is posted within the appropriate location of your facility. 2. As corrections become available, a local Vantive representative will contact your facility to determine the correction plan and schedule the associated correction(s) for impacted devices. 3. If you received this communication directly from Vantive, complete the enclosed Vantive Customer Reply Form and return it to Vantive by scanning and e-mailing it to [email protected]. Returning the customer reply form promptly will confirm your receipt of this notification and prevent you from receiving repeat notices. If you do not return the customer reply form, you will receive an email and/or phone call from Vantive to confirm your receipt of this notification. 4. If you purchased this product from a distributor, please note that responding using the Vantive Customer Reply Form is not applicable. If a response is requested by your distributor or wholesaler, please respond to the supplier according to their instructions. 5. If you distributed this product to other facilities or departments within your institution, please forward a copy of this communication to them. 6. If you are a dealer, wholesaler, distributor/reseller, or original equipment manufacturer (OEM) that distributed any affected product to other facilities, please notify your

Recall details

Recall number
Z-2437-2025
Status
Open, Classified
Initiated by the company
Jul 28, 2025
Posted by the FDA
Aug 26, 2025
Recalling firm
Vantive US Healthcare LLC
Quantity
4772 units
Product code
KDI
FDA submissions
K190910
Distribution
Worldwide

Product description

PrisMax V2-US, Hemodialysis Delivery System, Product Codes: 955626, 955558, 955627, 955701

Code information (models, lots, serial numbers)

UDI 00085412639499, All Serial Numbers

Devices named in this recall

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

Sources and updates

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