BEUDAMED
    FDA Recall Open, Classified

    Medline ReNewal Reprocessed ViewFlex Xtra ICE Catheters: ViewFlex Xtra ICE Catheter 9F x 90cm D087031RH 20197344019554

    Recall: Z-1323-2026 · Initiated December 22, 2025

    Recall

    Recall Number
    Z-1323-2026
    Event Number
    98277
    FEI Number
    1417592
    Product Code
    OWQ
    Status
    Open, Classified
    Root Cause
    Under Investigation by firm
    Initiated
    December 22, 2025
    Posted
    February 6, 2026
    Address
    3 Lakes Dr, Medline Industries, LP, Northfield, IL, 60093-2753

    Description

    Medline ReNewal Reprocessed ViewFlex Xtra ICE Catheters: ViewFlex Xtra ICE Catheter 9F x 90cm D087031RH 20197344019554

    Reason

    These lots of reprocessed catheters may contain small particles of residual material. If affected devices are used, there is a risk of inflammatory response, systemic infection, or granulomatous reaction or thrombus reaction which may lead to cerebral or pulmonary embolism, or deep vein thrombosis. Expansion of recall Z-2610/2614-2025

    Action

    On December 22, 2025, the firm issued Urgent Medical Device Recall letters as a follow-up to an earlier action in 2025 for the same issue, but newly identified item numbers and lots of previously identified item numbers. Notably, the products associated with the new/updated action are to be destroyed by the customer on-site for credit, and not returned to the manufacturer.

    Distribution

    Distribution US nationwide.

    Quantity

    650