BEUDAMED
    FDA Recall Terminated

    Edwards Lifesciences IntraClude Intra-Aortic Occlusion Device, model number ICF100, 10.5 Fr (3.5 mm) x 39.4" (100 cm) ThruPort System. Packaged sterile and non-pyrogenic in a sealed, peel-type pouch For use in patients undergoing cardiopulmonary bypass.

    Recall: Z-1758-2015 · Initiated May 5, 2015

    Recall

    Recall Number
    Z-1758-2015
    Event Number
    71269
    Firm
    Edwards Lifesciences, LLC
    FEI Number
    1713910
    Product Code
    DXC
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    May 5, 2015
    Posted
    June 11, 2015
    Terminated
    December 12, 2017
    Address
    12050 Lone Peak Pkwy, Draper, UT, 84020-9414

    Description

    Edwards Lifesciences IntraClude Intra-Aortic Occlusion Device, model number ICF100, 10.5 Fr (3.5 mm) x 39.4" (100 cm) ThruPort System. Packaged sterile and non-pyrogenic in a sealed, peel-type pouch For use in patients undergoing cardiopulmonary bypass.

    Reason

    Potential device damage on the strain relief near the hub area, which may result in blood leakage.

    Action

    Urgent Medical Device Safety Notice letters were sent via Fed-Ex by May 05, 2015. As part of the customer instructions in the safety notice, customers were requested to review the notice to understand the potential hazard, complete and return the acknowledgement form, and forward copies of the Safety Notice to any organization where the potentially affected devices have been transferred. The device will only be distributed to customers who have returned the acknowledgement form. Questions should be directed to Edwards Customer Service at 800-424-3278.

    Distribution

    Nationwide Distribution -- US, including the states of Alabama, Arizona, California, Colorado, Connecticut, Florida, Georgia, Idaho, Illinois, Kentucky, Louisiana, Massachusetts, Maine, Michigan, Missouri, Mississippi, North Carolina, Nebraska, New Jersey, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin, and West Virginia.

    Quantity

    3,360 units.