BEUDAMED
    FDA Enforcement Class I Ongoing

    Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO IM 125CM (5PK), REF H749085262402; cardiac catheter

    Recall: Z-1660-2024 · Reported May 22, 2024

    Enforcement

    Recall Number
    Z-1660-2024
    Event ID
    94240
    Classification
    Class I
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Boston Scientific Corporation
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    May 22, 2024
    Initiation Date
    March 21, 2024
    Classification Date
    May 10, 2024
    Address
    1 Scimed Pl, N/A, Maple Grove, MN, 55311-1565, United States

    Description

    Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO IM 125CM (5PK), REF H749085262402; 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.

    Code Info

    UDI/DI 08714729007593, Batch Numbers: 60444872, 60451459, 60451968, 60511220

    Distribution

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

    Quantity

    1065 catheters