BEUDAMED
    FDA Enforcement Class I Terminated

    Edwards SAPIEN 3 Ultra Transcatheter Heart Valve System (SAPIEN 3 Ultra Delivery System) (20 mm) 9630TF20 UDI:00690103201239

    Recall: Z-2224-2019 · Reported August 28, 2019

    Enforcement

    Recall Number
    Z-2224-2019
    Event ID
    83293
    Classification
    Class I
    Status
    Terminated
    Product Type
    Devices
    Firm
    Edwards Lifesciences, LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    August 28, 2019
    Initiation Date
    July 9, 2019
    Classification Date
    August 21, 2019
    Termination Date
    September 15, 2020
    Address
    1 Edwards Way, N/A, Irvine, CA, 92614-5688, United States

    Description

    Edwards SAPIEN 3 Ultra Transcatheter Heart Valve System (SAPIEN 3 Ultra Delivery System) (20 mm) 9630TF20 UDI:00690103201239

    Reason

    The action has been initiated to address reports of burst balloons which have resulted in significant difficulty retrieving the device into the sheath and withdrawing the system from the patient during procedures

    Code Info

    All Lots

    Distribution

    US: VA, CA, GA, MA, MD, NY, OR, WA, MN, TN, AL, KS OUS: United Kingdom, Switzerland, Sweden, Spain, Portugal, Poland, Norway, Netherlands, Italy, Ireland, Germany, Finland, Denmark, Canary Islands, Canada, Austria

    Quantity

    362 units