BEUDAMED
    FDA Recall Terminated

    Edwards SAPIEN 3 Transcatheter Heart Valve (THV), Model: 9600TFX, Size: 26 mm

    Recall: Z-2435-2018 · Initiated June 11, 2018

    Recall

    Recall Number
    Z-2435-2018
    Event Number
    80394
    Firm
    Edwards Lifesciences, LLC
    FEI Number
    2015691
    Product Code
    NPT
    Status
    Terminated
    Root Cause
    Labeling False and Misleading
    Initiated
    June 11, 2018
    Terminated
    May 23, 2019
    Address
    1 Edwards Way, Irvine, CA, 92614-5688

    Description

    Edwards SAPIEN 3 Transcatheter Heart Valve (THV), Model: 9600TFX, Size: 26 mm

    Reason

    SAPIEN 3 THV was packaged with the incorrect valve size with respect to the label.

    Action

    On 06/11/2018, the firm sent an Urgent Product Recall notice, via sales representative hand delivery, to the customer requesting they return the customer response form and the affected device. The customer was advised to call Customer Service at 1-800-424-3278, if they had any additional questions.

    Distribution

    NJ

    Quantity

    1 Valve