BEUDAMED
    FDA Enforcement Class II Terminated

    BOX1073076GASB1 BBR GASTRIC BYPASS S(Item Code BOX1073076GASB1 BBR GASTRIC BYPASS S) Product Usage: The Endo GIA universal and Endo GIA universal XL staplers place two, triple-staggered rows of titanium staples and simultaneously divides the tissue between the two, triple-staggered rows. The size of the staples is determined by the selection of the 2.0 mm, 2.5 mm, 3.5 mm or 4.8 mm single use loading unit. The Endo GIA universal staplers will accommodate any of the single use loading unit sizes that are available in the 30 mm, 45 mm and 60 mm lines.

    Recall: Z-1828-2018 · Reported May 23, 2018

    Enforcement

    Recall Number
    Z-1828-2018
    Event ID
    79974
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    COVIDIEN MEDTRONIC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    May 23, 2018
    Initiation Date
    April 26, 2018
    Classification Date
    July 6, 2018
    Termination Date
    June 17, 2020
    Address
    60 NIDDLETOWN AVE 2ND F, NORTH HAVEN, CT, 06473, United States

    Description

    BOX1073076GASB1 BBR GASTRIC BYPASS S(Item Code BOX1073076GASB1 BBR GASTRIC BYPASS S) Product Usage: The Endo GIA universal and Endo GIA universal XL staplers place two, triple-staggered rows of titanium staples and simultaneously divides the tissue between the two, triple-staggered rows. The size of the staples is determined by the selection of the 2.0 mm, 2.5 mm, 3.5 mm or 4.8 mm single use loading unit. The Endo GIA universal staplers will accommodate any of the single use loading unit sizes that are available in the 30 mm, 45 mm and 60 mm lines.

    Reason

    Device may be missing a sled component. The sled component is responsible for staple deployment. This may result in failure to form a staple line when tissue is divided, leading to bleeding or leakage of luminal contents.

    Code Info

    Lot 0215227169

    Distribution

    Worldwide and US Nationwide

    Quantity

    171,271 units in total