BEUDAMED
    FDA Recall Open, Classified

    TERUMO HydroPearl Compressible Microspheres for Embolisation REF 8HP2S600

    Recall: Z-0868-2024 · Initiated December 21, 2023

    Recall

    Recall Number
    Z-0868-2024
    Event Number
    93692
    Firm
    MICROVENTION INC.
    FEI Number
    3013556777
    Product Code
    NOY
    Status
    Open, Classified
    Root Cause
    Device Design
    Initiated
    December 21, 2023
    Posted
    January 31, 2024
    Address
    35 Enterprise, Aliso Viejo, CA, 92656

    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.

    Action

    On 12/21/2023, the firm sent an "URGENT MEDICAL DEVICE RECALL" Letter via FedEx Overnight Certified Letter to customers informing them that MicroVention is recalling one lot (#00003420470 of HYDRPEARL Microsphere Device (HP2S0600) due to the firm no following the prescribed manufacturing and quality processes and the affected product was inadvertently released for distribution. Specifically, the in-processing ageing step was mistakenly extended an additional five (5) days. Customers are instructed to: 1. Immediately stop using and quarantine the impacted HYDROPEARL device. 2. Inform all individuals with their organization of the recall and forward to any organizations that they may have received the affected products. 3. Complete the CUSTOMER ACKNOWLEDGEMENT FORM to [email protected] 4. If their institution has any affected inventory, contact Customer Care at 800-888-3786 or email [email protected] to request a recall return and received RGA details to return the device(s). For questions or assistance, contact Director, Post-Market Surveillance at [email protected]

    Distribution

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

    Quantity

    22 units