Class 2 Device Recall Prismax

• Date Initiated by Firm: July 28, 2025
• Date Posted: August 26, 2025
• Recall Status: Open, Classified
• Recall Number: Z-2438-2025
• Recall Event ID: 97233
• 510(K)Number: K193482
• Product Classification: Dialyzer, high permeability with or without sealed dialysate system - Product Code KDI
• Product: PrisMax V3 control Unit-US, Hemodialysis Delivery System, Product Code 955724
• Code Information: UDI 07332414126018, All serial numbers
• FEI Number: 3038195011
• Recalling Firm/ Manufacturer: VANTIVE US HEALTHCARE LLC; 510 Lake Cook Rd; Deerfield IL 60015-4964
• For Additional Information Contact: Vantive's customer service; 800-284-4060
• Manufacturer Reason for Recall: Unexpected PrisMax System alarm T0830: Blood Leak Detected, when no blood leak is present, or difficulty normalizing the Blood Leak Detector (BLD) leading to PrisMax System alarms T1313: BLD Normalize Failed, T0853: Normalization Failed, or T1205: BLD Self-Test Failure
• FDA Determined Cause: Under Investigation by firm
• Action: 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 FieldActions@vantive.com. 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
• Quantity in Commerce: 2449 units
• Distribution: Worldwide
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.

• 510(K) Database: 510(K)s with Product Code = KDI