BEUDAMED
    FDA Enforcement Class II Terminated

    Hot AXIOS Stent and Electrocautery - Enhanced Delivery System 20mm x10mm (OUS) UPN: M00553560 - Product Usage: The stent is intended for implantation up to 60 days and should be removed upon confirmation of pseudocyst or walled-off necrosis resolution.

    Recall: Z-0778-2021 · Reported January 13, 2021

    Enforcement

    Recall Number
    Z-0778-2021
    Event ID
    86909
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Boston Scientific Corporation
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    January 13, 2021
    Initiation Date
    December 1, 2020
    Classification Date
    January 6, 2021
    Termination Date
    July 14, 2023
    Address
    300 Boston Scientific Way, Marlborough, MA, 01752-1291, United States

    Description

    Hot AXIOS Stent and Electrocautery - Enhanced Delivery System 20mm x10mm (OUS) UPN: M00553560 - Product Usage: The stent is intended for implantation up to 60 days and should be removed upon confirmation of pseudocyst or walled-off necrosis resolution.

    Reason

    The rotating luer fitting at the distal end of the delivery system handle may become detached from the nose of the delivery during device preparation, stent delivery or use, resulting in delay or procedure or risk of peritonitis developing from leakage of enteric, pseudocyst, or biliary contents into the peritoneal cavity

    Code Info

    Lot Number: 26167277, 26171099, 26152171, 26171383, 26171380, 26152172 Exp. Date Range: 10/8/2021 10/12/2021 GTIN: 08714729951100

    Distribution

    US Nationwide distribution - Foreign: TBD.

    Quantity

    78 units