BEUDAMED
    FDA Enforcement Class II Terminated

    Rebel Monorail PtCr Coronary Stent System, REF / Catalog No. H7493927324300, Rebel MR OUS 3.0mm x 24mm. The Rebel Monorail (MR) Stent System is a balloon expandable Platinum Chromium (PtCr) Alloy stent pre-mounted on a Monorail Catheter.

    Recall: Z-0580-2020 · Reported December 4, 2019

    Enforcement

    Recall Number
    Z-0580-2020
    Event ID
    84152
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Boston Scientific Corporation
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Telephone
    Report Date
    December 4, 2019
    Initiation Date
    October 24, 2019
    Classification Date
    November 26, 2019
    Termination Date
    March 20, 2023
    Address
    1 Scimed Pl, Maple Grove, MN, 55311-1565, United States

    Description

    Rebel Monorail PtCr Coronary Stent System, REF / Catalog No. H7493927324300, Rebel MR OUS 3.0mm x 24mm. The Rebel Monorail (MR) Stent System is a balloon expandable Platinum Chromium (PtCr) Alloy stent pre-mounted on a Monorail Catheter.

    Reason

    Certain dilation and extension catheters are being recalled because these catheters may have missed the hydrophilic coating step, which creates a lubricious surface on the devices, during the manufacturing process.

    Code Info

    Lot / GTIN Number / Use By: 24077337 / 8714729843443 / 2019-07-17.

    Distribution

    Nationwide including Washington D.C. and Puerto Rico. OUS to include Canada.

    Quantity

    14,145 devices total