BEUDAMED
    FDA Enforcement Class II Ongoing

    TERUMO HydroPearl Compressible Microspheres for Embolisation REF 8HP2S600

    Recall: Z-0868-2024 · Reported February 7, 2024

    Enforcement

    Recall Number
    Z-0868-2024
    Event ID
    93692
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    MICROVENTION INC.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    February 7, 2024
    Initiation Date
    December 21, 2023
    Classification Date
    January 31, 2024
    Address
    35 Enterprise, Aliso Viejo, CA, 92656, United States

    Description

    TERUMO HydroPearl Compressible Microspheres for Embolisation REF 8HP2S600

    Reason

    Due to, during the manufacturing process, the prescribed manufacturing and quality processes were not followed and the product was inadvertently distributed.

    Code Info

    Model/Catalog Number: HP2S0600 UDI Code: (01)00816777026118(11)230710(17)260630(10)0000342047 Lot Number: 0000342047

    Distribution

    U.S. Nationwide distribution in the states of AZ, IL, LA, NC, TN, VA, and WI.

    Quantity

    22 units