BEUDAMED
    FDA Recall Open, Classified

    LIFEPEARL Drug Elutable Microspheres: 200 +/- 50 micrometers, REF: 8LP2S200; 400 +/- 50 micrometers, REF: 8LP2S400

    Recall: Z-2188-2025 · Initiated May 29, 2025

    Recall

    Recall Number
    Z-2188-2025
    Event Number
    96915
    Firm
    MICROVENTION INC.
    FEI Number
    3013556777
    Product Code
    KRD
    Status
    Open, Classified
    Root Cause
    Device Design
    Initiated
    May 29, 2025
    Posted
    July 28, 2025
    Address
    35 Enterprise, Aliso Viejo, CA, 92656

    Description

    LIFEPEARL Drug Elutable Microspheres: 200 +/- 50 micrometers, REF: 8LP2S200; 400 +/- 50 micrometers, REF: 8LP2S400

    Reason

    Drug Elutable Microspheres have a smaller actual average diameter that is not within specification, which may lead to inability to reach the desired treatment location (non-targeted embolization), additional procedure/treatment required, blockage other than target vessel, increased procedure time, incomplete embolization, and/or inability to treat the patient.

    Action

    On 5/29/2025, recall notices were mailed and emailed to customers who were asked to do the following: 1) Inform all individuals within your organization of the recall and forward the recall notice to any organizations that may have received the affected products. 2) Complete and return the customer acknowledgement form via email: [email protected] 3) If your institution has affected inventory call firm's Customer Care at 800-888-3786 or email [email protected] Please direct questions to the firm at [email protected]

    Distribution

    OUS: Italy, Spain, Portugal, Poland, Belgium, Germany, Denmark, France, Kazakhstan, Slovakia, Norway, Greece, Serbia, Turkey, Czech Republic, United Kingdom, Netherlands, Russian Federation, Kuwait, Republic of North Macedonia, Switzerland, Saudi Arabia, Georgia, Lithuania, Romania, Croatia, Chile, Hong Kong , India, Mexico, Taiwan, Vietnam

    Quantity

    1451