BEUDAMED
    FDA Recall Open, Classified

    Fogarty Thru-Lumen Embolectomy Catheter, REF: 12TLW805F35

    Recall: Z-0238-2024 · Initiated September 7, 2023

    Recall

    Recall Number
    Z-0238-2024
    Event Number
    93172
    Firm
    Edwards Lifesciences, LLC
    FEI Number
    2015691
    Product Code
    DXE
    Status
    Open, Classified
    Root Cause
    Nonconforming Material/Component
    Initiated
    September 7, 2023
    Posted
    November 6, 2023
    Address
    1 Edwards Way, Irvine, CA, 92614-5688

    Description

    Fogarty Thru-Lumen Embolectomy Catheter, REF: 12TLW805F35

    Reason

    Inadvertent release of embolectomy catheters that may experience slower than normal balloon deflation (greater-than 15 seconds).

    Action

    On 9/7/23, correction notices were sent to customers informing them to take the following actions: 2) Return affected devices. 3) Forward notice to any of your customers who have purchased the impacted devices. 3) Complete and return the acknowledgement form.

    Distribution

    OUS: Singapore, Taiwan, Canada

    Quantity

    185