LeMaitre Vascular, Inc.: Device Recall

Recall #Z-1751-2025 · 04/11/2025

Class II: Risk

Recall Details

Recall Number: Z-1751-2025
Classification: Class II
Product Type: Device
Recalling Firm: LeMaitre Vascular, Inc.
Status: Ongoing
Date Initiated: 04/11/2025
Location: Burlington, MA, United States
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 65,977 units

Reason for Recall

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

Product Description

Pruitt Occlusion Catheter. Catalog Numbers: 2103-36, 2103-46, 2103-56, E2103-36, E2103-46, E2103-56

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.

Other Recalls by LeMaitre Vascular, Inc.

Class II: Risk 09/25/2025

The device was incorrectly packed in the wrong size labeled outer packaging.
Class II: Risk 09/02/2025

The bovine carotid arteries used to produce the impacted grafts from affected lots were sourced using raw material from a supplier that had not been reviewed and approved by the appropriate regulatory authority.
Class II: Risk 08/25/2025

Devices were distributed with incorrect label without CE and UKCA mark, missing patient leaflet and patient implant card.
Class II: Risk 04/11/2025

During internal product testing, it was observed that some packages to have incomplete seals (sterile barrier).
Class II: Risk 04/11/2025

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

View all recalls by LeMaitre Vascular, Inc. →

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.