Home / Recalls / LeMaitre Vascular, Inc. / Z-1750-2025

Z-1750-2025 Class II Ongoing

Recalled by LeMaitre Vascular, Inc. — Burlington, MA

FDA device recall Z-1750-2025 was initiated by LeMaitre Vascular, Inc. on April 11, 2025 and is designated Class II. Reason for recall: During internal product testing, it was observed that some packages to have incomplete seals (sterile barrier). The recall status is ongoing. Affected quantity: 237,611 units.

Recall Details

Product Type: Devices
Report Date: May 21, 2025
Initiation Date: April 11, 2025
Termination Date: N/A
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 237,611 units

Product 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 for Recall

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

Distribution Pattern

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.

Code Information

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

Other recalls by LeMaitre Vascular, Inc.

Z-1574-2026 Class II — Artegraft Vascular Graft; REF#: AG740; (February 10, 2026)
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Z-0072-2026 Class II — Artegraft Collagen Vascular Graft. Model/Catalog/Part Numbers: AG630M, AG636M, (August 25, 2025)
Z-1751-2025 Class II — Pruitt Occlusion Catheter. Catalog Numbers: 2103-36, 2103-46, 2103-56, E2103-36, (April 11, 2025)
Z-1752-2025 Class II — Pruitt Irrigation Occlusion Catheter. Catalog Numbers: 2102-09, E2102-09. (April 11, 2025)
Z-1824-2024 Class II — Syntel Silicone Thrombectomy Catheter, Sterile, Rx Only. Used in vascular grafts (April 17, 2024)
Z-2468-2023 Class II — The Chevalier Valvulotome is a device used to disrupt the valves of veins which (July 13, 2023)
Z-0228-2023 Class II — TufTex Embolectomy Catheter, Model No. This catheter has a latex balloon and (September 30, 2022)
Z-1529-2021 Class II — LeverEdge Contrast Injector: 35 cc syringe with ISO 594 female luer lock - Produ (April 6, 2021)