BEUDAMED
    FDA Recall Open, Classified

    Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO AR MOD (5PK), REF H74908526892; cardiac catheter

    Recall: Z-1682-2024 · Initiated March 21, 2024

    Recall

    Recall Number
    Z-1682-2024
    Event Number
    94240
    Firm
    Boston Scientific Corporation
    FEI Number
    3002095335
    Product Code
    DQO
    Status
    Open, Classified
    Root Cause
    Under Investigation by firm
    Initiated
    March 21, 2024
    Posted
    May 10, 2024
    Address
    1 Scimed Pl, Maple Grove, MN, 55311-1565

    Description

    Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO AR MOD (5PK), REF H74908526892; cardiac catheter

    Reason

    An increase in complaints related to an inability to advance the guidewire through the lumen of the device for certain batches. There is evidence of the polyurethane layer delaminating and in some instances material detachment in the catheters inner lining.

    Action

    Boston Scientific issued an Urgent Medical Device Removal notice to its consignees on 03/21/2024 via overnight delivery. The notice explained the issue, the potential risk, and requested the removal of the affected products. Distributors were directed to notify their consignees.

    Distribution

    Worldwide distribution. US, US Territories, EMEA, Canada, LATAM and Asia Pacific countries/regions.

    Quantity

    4942 catheters