BEUDAMED
    FDA Enforcement Class II Ongoing

    Boston Scientific Guider Softip XF, 40 XF, 8F, Guide Catheter, REF H965100440

    Recall: Z-1582-2022 · Reported August 31, 2022

    Enforcement

    Recall Number
    Z-1582-2022
    Event ID
    90735
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Boston Scientific Corporation
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    August 31, 2022
    Initiation Date
    August 9, 2022
    Classification Date
    August 25, 2022
    Address
    1 Scimed Pl, Maple Grove, MN, 55311-1565, United States

    Description

    Boston Scientific Guider Softip XF, 40 XF, 8F, Guide Catheter, REF H965100440

    Reason

    The impacted products were distributed with an MPXF tip curve shape instead of the 40XF tip curve shape for the Guider/40XF/8FR/90CM guide catheter.

    Code Info

    UDI/DI 08714729202486, Lot/Batch 27339850, Use By 2021-05-18, and UPDATE: Lot/Batch 29308869, Use By 4/27/2025.

    Distribution

    International distribution in the countries of Greece, France, Germany, Italy, Brazil and South Korea. UPDATE: The devices were also distributed to Russia. There was no U.S. distribution.

    Quantity

    184 devices (UPDATED)