BEUDAMED
    FDA Recall Terminated

    Sorin Group Aortic Arch Cannula, 7 mm x 10 in x 3/8 in, Rx Only, Sterile Product Usage: The Aortic Arch Cannulae are indicated for use in perfusion of the ascending aorta during cardiopulmonary bypass surgery.

    Recall: Z-2871-2017 · Initiated June 9, 2017

    Recall

    Recall Number
    Z-2871-2017
    Event Number
    77699
    Firm
    Sorin Group USA, Inc.
    FEI Number
    1718850
    Product Code
    DWF
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    June 9, 2017
    Terminated
    November 9, 2023
    Address
    14401 W 65th Way, Arvada, CO, 80004-3503

    Description

    Sorin Group Aortic Arch Cannula, 7 mm x 10 in x 3/8 in, Rx Only, Sterile Product Usage: The Aortic Arch Cannulae are indicated for use in perfusion of the ascending aorta during cardiopulmonary bypass surgery.

    Reason

    Identification of excess plastic on the tip of the cannula.

    Action

    LivaNova sent an Urgent Medical Device letter dated June 16, 2017 to affected customers via certified mail or e-mail. The letter identified the affected product, problem and actions to be taken. The notice instructs customers to remove all recalled product from inventory and contact LivaNova Customer Support at 800-650-2623 to arrange for product return and replacement.

    Distribution

    Worldwide Distribution - US Nationwide in the states of : AR, AZ, CA, GA, IL, IN, KS, MI, MN, MO, NC, NE, NY, OK, PA, SD, TX, & VA. and foreign countries of: Canada, Iran, Mexico, & New Zealand.

    Quantity

    105,770 units