BEUDAMED
    FDA Recall Open, Classified

    PASCAL Precision Transcatheter Valve Repair System, Models: 20000ISM and 20000IS

    Recall: Z-2479-2023 · Initiated July 27, 2023

    Recall

    Recall Number
    Z-2479-2023
    Event Number
    92804
    Firm
    Edwards Lifesciences, LLC
    FEI Number
    2015691
    Product Code
    NKM
    Status
    Open, Classified
    Root Cause
    Process change control
    Initiated
    July 27, 2023
    Posted
    August 29, 2023
    Address
    1 Edwards Way, Irvine, CA, 92614-5688

    Description

    PASCAL Precision Transcatheter Valve Repair System, Models: 20000ISM and 20000IS

    Reason

    Due to a manufacturing issue, when using valve repair systems, intended to repair insufficient mitral and/or tricuspid valves, users experienced resistance when attempting to release the implant from the delivery system by rotating the release knob. Additional torque required to initiate rotation of the release wire from the implant, could cause implant rotation or additional implant implantation.

    Action

    On 7/27/23, recall notices were sent to customers and distributors who were asked to do the following: 1) Stop using and work with your firm representative to return affected devices. 2) Share this notice with the appropriate clinical staff at your site. 3) Complete and return the customer acknowledgement form. 4) Distributors: Notify your customers by sending this customer notification to any of your customers who have purchased the impacted devices.

    Distribution

    International distribution to the countries of Austria, Belgium, Switzerland, Germany, Cyprus, Israel, UK, Greece, Ireland, Italy, Luxembourg, Poland.

    Quantity

    92