BEUDAMED
    FDA Enforcement Class II Terminated

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

    Recall: Z-2435-2018 · Reported July 25, 2018

    Enforcement

    Recall Number
    Z-2435-2018
    Event ID
    80394
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Edwards Lifesciences, LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    July 25, 2018
    Initiation Date
    June 11, 2018
    Classification Date
    July 13, 2018
    Termination Date
    May 23, 2019
    Address
    1 Edwards Way, Irvine, CA, 92614-5688, United States

    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.

    Code Info

    Use By: 2020-01-24, Serial #: 6005731, UDI #: (01)00690103194357(17)200124(21)6005731

    Distribution

    NJ

    Quantity

    1 Valve