BEUDAMED
    FDA Enforcement Class II Ongoing

    Syntel Silicone Thrombectomy Catheter, Sterile, Rx Only. Used in vascular grafts and peripheral venous thrombectomies.

    Recall: Z-1824-2024 · Reported May 22, 2024

    Enforcement

    Recall Number
    Z-1824-2024
    Event ID
    94457
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    LeMaitre Vascular, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    May 22, 2024
    Initiation Date
    April 17, 2024
    Classification Date
    May 15, 2024
    Address
    32 3rd Ave, N/A, Burlington, MA, 01803-4414, United States

    Description

    Syntel Silicone Thrombectomy Catheter, Sterile, Rx Only. Used in vascular grafts and peripheral venous thrombectomies.

    Reason

    The guide tip can become damaged and result in the tip detaching.

    Code Info

    Item No. A4545, A4548, A4554, A4558, A4568; GTIN: 840663109807, 840663109838, 840663109814, 840663109821, 840663109845; Lot No: SST1004, SST1005, SST1006, SST1007, SST1009, SST1010, SST1013, SST1018, SST1019, SST1020, SST1021, SST1022, SST1023, SST1024, SST1025, SST1026, SST1027, SST1028, SST1029, SST1030, SST1031, SST1032, SST1033, SST1034, SST1035, SST1036, SST1037, SST1038, SST1041, SST1042, SST1043, SST1044, SST1045, SST1046, SST1047, SST1048, SST1049, SST1050, SST1051, SST1054, SST1055, SST1056, SST1057, SST1058, SST1059, SST1060, SST1061, SST1062, SST1063, SST1064, SST1065, SST1066, SST1067, SST1068, SST1071.

    Distribution

    Worldwide distribution - US Nationwide and the countries of Australia, Canada, and Spain.

    Quantity

    5,604 units