BEUDAMED
    FDA Enforcement Class II Ongoing

    Autotome RX 20mm CUT WIRE Cannulating Sphincterotome, Material Number (UPN) M00545170. The device is used in selective cannulation of the bile duct.

    Recall: Z-2350-2024 · Reported July 24, 2024

    Enforcement

    Recall Number
    Z-2350-2024
    Event ID
    94827
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Boston Scientific Corporation
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    July 24, 2024
    Initiation Date
    June 12, 2024
    Classification Date
    July 12, 2024
    Address
    100 Boston Scientific Way, Marlborough, MA, 01752-1234, United States

    Description

    Autotome RX 20mm CUT WIRE Cannulating Sphincterotome, Material Number (UPN) M00545170. The device is used in selective cannulation of the bile duct.

    Reason

    Foreign material may be present on the enclosed section of the cutting wire which may lead to inability to optimally bow the sphincterotome. This issue may lead to prolongation of procedure.

    Code Info

    UDI-DI (GTIN) 08714729444749 Lot 33280747 Expiration Date: January 23, 2027

    Distribution

    Domestic distribution nationwide.

    Quantity

    256 US, 39 OUS