BEUDAMED
    FDA Recall Terminated

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

    Recall: Z-2878-2018 · Initiated May 7, 2018

    Recall

    Recall Number
    Z-2878-2018
    Event Number
    80720
    Firm
    Biosense Webster, Inc.
    FEI Number
    3003113629
    Product Code
    NGV
    Status
    Terminated
    Root Cause
    Component design/selection
    Initiated
    May 7, 2018
    Terminated
    November 14, 2020
    Address
    15715 Arrow Hwy, Irwindale, CA, 91706-2006

    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.

    Action

    Coherex Medical notified customers via "URGENT FIELD SAFETY NOTICE Coherex WaveCrest Left Atrial Appendage (LAA) Occlusion System (32 mm) Catalog No: WCR1523, Lot Number: All" letter dated May 7, 2018. The letter provided an overview, and important information about the product description and codes, lots subject to removal, why customers were being contacted, What actions are required/instructions, available assistance/contact information, and Reply Form.

    Distribution

    No U.S. Distribution. International Distribution only.

    Quantity

    25 units