BEUDAMED
    FDA Enforcement Class I Terminated

    WaveCrest Left Atrial Appendage (LAA), Occlusion System (32 mm), Catalog Numbers WCR1523 and WCR2523.

    Recall: Z-2878-2018 · Reported September 5, 2018

    Enforcement

    Recall Number
    Z-2878-2018
    Event ID
    80720
    Classification
    Class I
    Status
    Terminated
    Product Type
    Devices
    Firm
    Biosense Webster, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    September 5, 2018
    Initiation Date
    May 7, 2018
    Classification Date
    August 30, 2018
    Termination Date
    November 14, 2020
    Address
    15715 Arrow Hwy, N/A, Irwindale, CA, 91706-2006, United States

    Description

    WaveCrest Left Atrial Appendage (LAA), Occlusion System (32 mm), Catalog Numbers WCR1523 and WCR2523.

    Reason

    When attempting to recapture the 32-mm device, the tip of the delivery sheath may fold or buckle, resulting in increased retraction force and difficulty or failure to recapture the device.

    Code Info

    All lots.

    Distribution

    No U.S. Distribution. International Distribution only.

    Quantity

    25 units