LeMaitre Pruitt Occlusion Catheter Recall: Incomplete Sterile Seals
LeMaitre Vascular recalls Pruitt Occlusion Catheters with incomplete sterile seals. Affected catalog numbers include 2103-36, 2103-46, 2103-56 and E variants. Contact for remedy details.
Lower-risk recall
During internal product testing, it was observed that some packages to have incomplete seals (sterile barrier).
Contact the company
What happened, in plain English
LeMaitre Vascular is recalling Pruitt Occlusion Catheters that may have incomplete sterile seals during manufacturing. This could lead to contamination risks during medical procedures if the catheter is used without a proper sterile barrier. Read more at govinfonow.com/recall/52463-lemaitre-pruitt-occlusion-catheter-recall-incomplete-sterile-seals.
Source Summary by GovInfoNow · govinfonow.com/recall/52463-lemaitre-pruitt-occlusion-catheter-recall-incomplete-sterile-seals · Updated August 18, 2026 · FDA enforcement record: FDA #Z-1751-2025
Cite this page
“LeMaitre Pruitt Occlusion Catheter Recall: Incomplete Sterile Seals.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/52463-lemaitre-pruitt-occlusion-catheter-recall-incomplete-sterile-seals. Based on FDA recall #Z-1751-2025 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1751-2025%22&limit=1).
Why it’s dangerous
Incomplete sterile seals could allow contamination during medical procedures. This might lead to infections or other complications if the catheter is used without a proper sterile barrier.
Who’s affected
Healthcare professionals using these catheters for medical procedures are most at risk. Patients receiving the catheters during procedures may also be affected if the seals are incomplete.
How to tell if you have this one
Check for catalog numbers 2103-36, 2103-46, 2103-56, or E2103-36, E2103-46, E2103-56. Products with lot prefixes POC, QPO, or XPO are affected.
- Brand
LeMaitre Vascular- Category
Medical device
All 3 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
- Classification
Class II- Status
Ongoing- 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.
| Recall number | Product, codes & lots | Quantity |
|---|---|---|
| Z-1750-2025 | 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.; 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 | 237,611 units |
| Z-1751-2025 | Pruitt Occlusion Catheter. Catalog Numbers: 2103-36, 2103-46, 2103-56, E2103-36, E2103-46, E2103-56; UDI-DI: 00840663101535, 00840663101542. Catalog Numbers: 2103-36, 2103-46, 2103-56, E2103-36, E2103-46, E2103-56. Lots not expired with the following prefix: POC, QPO, XPO. | 65,977 units |
| Z-1752-2025 | Pruitt Irrigation Occlusion Catheter. Catalog Numbers: 2102-09, E2102-09.; UDI-DI: 00840663101580, 00840663101559, 00840663101566, 00840663101597, 00840663101573, 00840663101603. Catalog Numbers: 2102-09, E2102-09. Lot not expired with the following prefix: PIO, QPI, XPI. | 26,872 units |
What to do — step by step
Check Product Details
Review the catalog numbers and lot prefixes to confirm if your catheter is affected.
Where it went and when
Where it was distributed
Distributed nationwide, and outside the U.S.
FDA 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,…” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide, and outside the U.S.
Recall timeline
FDA published this recall 40 days after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #Z-1751-2025 (April 11, 2025) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1751-2025 to see it in context.
- Plain-language summary written by qwen3:4b on August 18, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.