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RecallWatchMedical Device Safety
Class IIOngoingZ-1751-2025

LeMaitre Vascular, Inc. recalls Pruitt Occlusion Catheter. Catalog Numbers: 2103-36

LeMaitre Vascular, Inc.Burlington, MA, United StatesReported May 21, 2025 · 1 year ago
Legal News Analyst ·

Reason for recall

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

Affected product

Check your device

Enter a lot, serial, REF, or UDI number from your device's label to check it against this recall's listed codes.

Affected products & lots

  • Pruitt Occlusion Catheter. Catalog Numbers: 2103-36, 2103-46, 2103-56, E2103-36, E2103-46E2103-56
    UDI-DI 00840663101535Catalog # Numbers

What the firm is doing

LeMaitre notified OUS consignees beginning on 04/11/2025, and US consignees on 04/23/2025 via email and letter. Consignees were instructed to not use the devices, immediately quarantine any on hand, and complete and return the response form. Once received a LeMaitre Vascular representative will contact customers to provide return instructions. If the products were transferred or further distributed, customers were instructed to notify those customers and provide a copy of the recall letter.

DistributionShow details

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.

Class IIWhat this means

Use of the product may cause temporary or medically reversible adverse health consequences.

Sources & references

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.

Taylor Coteus
Legal News Analyst

Taylor Coteus is RecallWatch's Legal News Analyst, covering FDA medical-device enforcement and patient-safety litigation. He reviews every recall against the FDA's official openFDA record before it is published and is responsible for corrections and editorial accuracy.

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