BEUDAMED
    FDA Recall Open, Classified

    Philips Bridge Prep Kit REF: K12-09098B Sterile EO, Rx ONLY

    Recall: Z-2002-2026 · Initiated April 2, 2026

    Recall

    Recall Number
    Z-2002-2026
    Event Number
    98637
    Firm
    Merit Medical Systems, Inc.
    FEI Number
    1721504
    Product Code
    OEQ
    Status
    Open, Classified
    Root Cause
    Nonconforming Material/Component
    Initiated
    April 2, 2026
    Posted
    April 29, 2026
    Address
    1600 W Merit Pkwy South, Jordan, UT, 84095-2416

    Description

    Philips Bridge Prep Kit REF: K12-09098B Sterile EO, Rx ONLY

    Reason

    catheter may experience resistance when being advanced over the guidewire

    Action

    On April 17, 2026, Merit Medical Issued a Urgent Medical Device Recall notification via: FedEx. Initial notification was issued on April 2, 2026 via E-Mail and FedEx. Merit ask consignees to take the following actions: 1. Ensure that applicable personnel within your organization are made aware of this safety notice. 2. If the product has been further distributed to other facilities, institutions, or manufacturers, please immediately share this safety notice in accordance with your company policies. Please consider communicating the following to your customers: a. For continued safe use of the Philips Bridge" and Philips Bridge" Plus Occlusion Balloons, as outlined in the Prophylactic Directions for Use in the IFU, the following actions should be taken prior to the beginning of any procedure to confirm proper interaction between devices: i. After placement of the guidewire, advance the Balloon over the guidewire. This will confirm that the Balloon can freely be advanced over the entire length of the guidewire without resistance, thereby confirming that the guidewire is compatible with the Balloon. ii. Should resistance be felt during this step, the guidewire should be replaced with an alternate 0.035 stiff/super stiff wire, and Step 1 should be repeated prior to the beginning of the procedure. 3. Please circulate this information to all users of the Philips Bridge", Philips Bridge" Plus, and Bridge" Prep Kit device, or to any organization where the affected product may have been transferred, so that they are aware of the issue. Merit encourages you to instruct your customers to post the safety notice on or near the affected products.

    Distribution

    US Nationwide distribution in the state of CO.