# FDA recall Z-1752-2025

> **LeMaitre Vascular, Inc.** · Class II · device recall initiated 2025-04-11.

## Product

Pruitt Irrigation Occlusion Catheter. Catalog Numbers: 2102-09, E2102-09.

## Reason for recall

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

## 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.

## Key facts

- **Recall number:** Z-1752-2025
- **Recalling firm:** LeMaitre Vascular, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2025-04-11
- **Report date:** 2025-05-21

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Burlington, MA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1752-2025

## Citation

> AI Analytics. FDA recall Z-1752-2025. Retrieved 2026-07-17 from https://api.ai-analytics.org/recall/Z-1752-2025. Source: US FDA. Licensed CC0.

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