BEUDAMED
    FDA Recall Open, Classified

    TheraSphere Administration Set, REF OTT-SPE-FP-001 (990264.SPE)

    Recall: Z-2328-2021 · Initiated July 23, 2021

    Recall

    Recall Number
    Z-2328-2021
    Event Number
    88369
    Firm
    Boston Scientific Corporation
    FEI Number
    3002095335
    Product Code
    NAW
    Status
    Open, Classified
    Root Cause
    Component change control
    Initiated
    July 23, 2021
    Posted
    August 19, 2021
    Address
    1 Scimed Pl, Maple Grove, MN, 55311-1565

    Description

    TheraSphere Administration Set, REF OTT-SPE-FP-001 (990264.SPE)

    Reason

    Potential for leaks and loosening at the patient catheter connection

    Action

    The firm disseminated a Medical Device Product Advisory on 07/23/2021 by overnight mail delivery. The letter explained the issue and directed users to ensure a firm connection is made between the outlet luer and the patient catheter prior to, and during ThersSphere administration.

    Distribution

    Worldwide distribution - US Nationwide and the countries of Belgium, Canada, Germany, Spain, France, United Kingdom/Great Britain, Hong Kong, Ireland, Israel, India, Italy, Netherlands, Poland, Portugal, Saudi Arabia, Singapore, Switzerland, Turkey, and Argentina.

    Quantity

    4200 sets