LeMaitre Vascular, Inc. recalls Pruitt Occlusion Catheter. Catalog Numbers: 2103-36
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, E2103-46E2103-56UDI-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 detailsHide
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.
Use of the product may cause temporary or medically reversible adverse health consequences.
Sources & references
- FDA enforcement recordOfficial FDA database entry for Z-1751-2025
- FDA 510(k) clearance · K811276The device's official FDA premarket clearance record
- FDA device classification · DYGOfficial FDA classification for this device type
- CFR regulation · 21 CFR 870.1240The federal regulation governing this device
- FDA recall announcementSearch FDA.gov for the official press announcement
- Find LeMaitre Vascular, Inc.Search for the manufacturer's official notice
- News coverageRecent reporting on this recall and manufacturer
- openFDA data recordThe raw JSON record this page is built from
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 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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