BEUDAMED
    FDA Recall Open, Classified

    WATCHDOG Hemostasis Valve Kit, UPN H74939343A022 (outer package), UPN H74939343A020 (inner package)

    Recall: Z-1592-2023 · Initiated April 5, 2023

    Recall

    Recall Number
    Z-1592-2023
    Event Number
    92072
    Firm
    Boston Scientific Corporation
    FEI Number
    3002095335
    Product Code
    DTL
    Status
    Open, Classified
    Root Cause
    Process control
    Initiated
    April 5, 2023
    Posted
    May 16, 2023
    Address
    1 Scimed Pl, Maple Grove, MN, 55311-1565

    Description

    WATCHDOG Hemostasis Valve Kit, UPN H74939343A022 (outer package), UPN H74939343A020 (inner package)

    Reason

    The firm received complaints of the Insertion Tool component being occluded, resulting in the inability to pass a guidewire through the tool.

    Action

    Boston Scientific issued an URGENT MEDICAL DEVICE PRODUCT REMOVAL notice on 04/05/2023 by overnight mail. The notice explained the issue and the hazard and requested the consignee segregate the devices pending return. Medical facilities who distributed the devices and distributors were directed to send the notice to their customers.

    Distribution

    Worldwide

    Quantity

    1300 units