BEUDAMED
    FDA Recall Open, Classified

    Syntel Silicone Thrombectomy Catheter, Sterile, Rx Only. Used in vascular grafts and peripheral venous thrombectomies.

    Recall: Z-1824-2024 · Initiated April 17, 2024

    Recall

    Recall Number
    Z-1824-2024
    Event Number
    94457
    Firm
    LeMaitre Vascular, Inc.
    FEI Number
    1220948
    Product Code
    DXE
    Status
    Open, Classified
    Root Cause
    Under Investigation by firm
    Initiated
    April 17, 2024
    Posted
    May 15, 2024
    Address
    32 3rd Ave, Burlington, MA, 01803-4414

    Description

    Syntel Silicone Thrombectomy Catheter, Sterile, Rx Only. Used in vascular grafts and peripheral venous thrombectomies.

    Reason

    The guide tip can become damaged and result in the tip detaching.

    Action

    Consignees were mailed an URGENT MEDICAL DEVICE RECALL Notification, dated 4/10/2024. The notification instructs consignees to inspect their inventory for and quarantine affected devices, complete and return the provided Response Form to [email protected], and return affected devices for credit. If product was further distributed, the recall notification is to be forwarded for customer awareness. Consignees with any questions are to contact Rose Lerer at [email protected] from Monday through Friday, 8:00 AM to 4:30 PM EST.

    Distribution

    Worldwide distribution - US Nationwide and the countries of Australia, Canada, and Spain.

    Quantity

    5,604 units