BEUDAMED
    FDA Enforcement Class II Ongoing

    TufTex Over-the-Wire Embolectomy Catheter. All Catalog numbers: 1651-34, 1651-38, 1651-44, 1651-48, 1651-58, 1651-64, 1651-68, 1651-78, 1651-84, 1651-88, E1651-34, E1651-38, E1651-44, E1651-48, E1651-64, E1651-68, E1651-78, E1651-84, E1651-88, 1651-44J, 1651-48J, 1651-84J, 1651-88J.

    Recall: Z-1750-2025 · Reported May 21, 2025

    Enforcement

    Recall Number
    Z-1750-2025
    Event ID
    96716
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    LeMaitre Vascular, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    May 21, 2025
    Initiation Date
    April 11, 2025
    Classification Date
    May 12, 2025
    Address
    32 3rd Ave, Burlington, MA, 01803-4414, United States

    Description

    TufTex Over-the-Wire Embolectomy Catheter. All Catalog numbers: 1651-34, 1651-38, 1651-44, 1651-48, 1651-58, 1651-64, 1651-68, 1651-78, 1651-84, 1651-88, E1651-34, E1651-38, E1651-44, E1651-48, E1651-64, E1651-68, E1651-78, E1651-84, E1651-88, 1651-44J, 1651-48J, 1651-84J, 1651-88J.

    Reason

    During internal product testing, it was observed that some packages to have incomplete seals (sterile barrier).

    Code Info

    UDI-DI: 00840663100651, 00840663100668, 00840663100675, 00840663100682, 00840663100699, 00840663100705, 00840663100712, 00840663100729, 00840663107551, 00840663100736, 00840663100743, 00840663100750, 00840663100767, 00840663100774, 00840663100781, 00840663100798, 00840663100804, 00840663100811, 00840663100828, 00840663100835, 00840663107568, 00840663100842, 00840663100859, 00840663100866. Catalog numbers: 1651-34, 1651-38, 1651-44, 1651-48, 1651-68, 1651-78, 1651-84, 1651-88, E1651-34, E1651-38, E1651-44, E1651-48, E1651-64, E1651-68, E1651-78, E1651-84, E1651-88. Lots not expired with the following prefix: OTW, QOT, XOT, COT

    Distribution

    Nationwide distribution. International distribution to ARGENTINA, AUSTRALIA, AUSTRIA, BELGIUM, BRAZIL, BULGARIA, CAMBODIA, CANADA, CHILE, COLOMBIA, COSTA RICA, CYPRUS, CZECHIA, DENMARK, DOMINICAN REPUBLIC, EGYPT, EL SALVADOR, ESTONIA, FINLAND, FRANCE, GEORGIA, GERMANY, GREECE, GUATEMALA, GUYANA, HONG KONG, HUNGARY, INDIA, INDONESIA, IRELAND, ISRAEL, ITALY, JAPAN, JORDAN, KUWAIT, LATVIA, LEBANON, LITHUANIA, MALAYSIA, MALTA, MEXICO, MONGOLIA, MOROCCO, NETHERLANDS, NEW ZEALAND, NICARAGUA, NORTH MACEDONIA, NORWAY, OMAN, PANAMA, PARAGUAY, PHILIPPINES, POLAND, QATAR, ROMANIA, RUSSIA, SAUDI ARABIA, SERBIA, SINGAPORE, SLOVAKIA, SLOVENIA, SOUTH AFRICA, SOUTH KOREA, SPAIN, SWEDEN, SWITZERLAND, TAIWAN, THAILAND, TRINIDAD AND TOBAGO, TUNISIA, TURKIYE, UNITED ARAB EMIRATES, UNITED KINGDOM, VENEZUELA, VIETNAM.

    Quantity

    237,611 units