BEUDAMED
    FDA Recall Open, Classified

    Avanta Multi-Patient Administration Tube Sets (AVA 500 MPAT (Part 2 of 2)) used with the Medrad Avanta Injection System; Catalog number: AVA 500 MPAT (Part 2 of 2); Affected material numbers: 87629007, 60729458, 86566648;

    Recall: Z-2296-2026 · Initiated April 24, 2026

    Recall

    Recall Number
    Z-2296-2026
    Event Number
    98881
    Firm
    Bayer Medical Care, Inc.
    FEI Number
    2520313
    Product Code
    DXT
    Status
    Open, Classified
    Root Cause
    Process control
    Initiated
    April 24, 2026
    Posted
    June 3, 2026
    Address
    1 Bayer Dr, Indianola, PA, 15051-9702

    Description

    Avanta Multi-Patient Administration Tube Sets (AVA 500 MPAT (Part 2 of 2)) used with the Medrad Avanta Injection System; Catalog number: AVA 500 MPAT (Part 2 of 2); Affected material numbers: 87629007, 60729458, 86566648;

    Reason

    Supplier changes resulted in a fit issue with the Contrast Flow Control Valve (CFCV) interface on the Avanta Injector System. Multiple customer reports indicate that the stopcock cannot be reliably engaged with the CFCV snap interface. In instances where engagement is achieved through applied force, the connection is unstable, and the stopcock may disengage before or during contrast injection, leading to procedure interruption.

    Action

    On April 24, 2026, URGENT MEDICAL DEVICE RECALL letters were sent to customers. Customers were instructed to immediately halt the use of the affected product and review inventory for impacted product and quarantine. A Return Goods Authorization will be sent to return any remaining affected inventory. Place the affected product in a box and label the outside of the container with the RGA number provided and RECALL ID: SA-2026-RAD-03 in large, bold writing. Use the shipping label provided via email when you receive your RGA number. Please return the affected product as soon as possible. Please distribute this letter to other appropriate departments and personnel within your facility who may need awareness of this recall.

    Distribution

    Worldwide - US Nationwide distribution including in the states of AL, AR, AZ, CA, CO, DE, FL, IA, IL, IN, KS, KY, LA, MA, MD, ME, MO, NC, NY, OH, OK, PA, SC, TN, TX, VA, WI and the countries of AE, BA, BE, CA, CH, CN, DE, DK, ES, FR, GB, HK, HR, IL, KW, MT, MX, NL, RO, RU, SE, ZA.

    Quantity

    11,300 units (1650 US, 9650 OUS)