BEUDAMED
    FDA Enforcement Class II Ongoing

    Guider Softip Guide Catheter 6F PRE-SHAPED 40 90CM, Catalog number H965100420, cardiac guide catheter

    Recall: Z-0009-2024 · Reported October 11, 2023

    Enforcement

    Recall Number
    Z-0009-2024
    Event ID
    92785
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Boston Scientific Corporation
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    October 11, 2023
    Initiation Date
    July 27, 2023
    Classification Date
    October 3, 2023
    Address
    1 Scimed Pl, N/A, Maple Grove, MN, 55311-1565, United States

    Description

    Guider Softip Guide Catheter 6F PRE-SHAPED 40 90CM, Catalog number H965100420, cardiac guide catheter

    Reason

    Stryker Neurovascular has observed that certain lots of Guider Softip XF Guide Catheters appear to have the incorrect tip curve shape. The impacted products were distributed with a tip curve shape which differs from the labeled tip curve shape.

    Code Info

    GTIN 08714729202462, Lot/Batch Numbers: 25651700, 25651701, 25651702, 25651703, 25651704, 25651705, 25651706, 25651708, 25651709, 25651710, 25651711, 25761340, 25761341, 25761342, 25761343, 25964544, 25964545, 25964546, 25964547, 26019585, 26019586, 26034354, 26034357, 26138841, 26138842, 26138844, 26338705, 26338706, 26338707, 26338708, 26411750, 26411751, 26411752, 26745645, 26745646, 26891497, 27269743, 27654465, 27696356, 27703700, 27809357, 27996305, 26019584, 28107548, 28158175, 26019587, 28502663, 28502664, 28502665, 28584619, 28737891, 28737892, 28737893, 28795036, 28886611, 28886612, 29112775, 29112777, 26138843, 26138845, 26338704, 26338709, 26498390, 26891295, 26891496, 27103345, 27762224, 27809358, 28091480, 28384635, 28502662, 28795035, 28795037

    Distribution

    US Nationwide distribution in the state of Indiana.

    Quantity

    4990 units