Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

Pruitt Occlusion Catheter. Catalog Numbers: 2103-36 Recalled by LeMaitre Vascular, Inc. Due to During internal product testing, it was observed that...

Date: April 11, 2025
Company: LeMaitre Vascular, Inc.
Status: Ongoing
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact LeMaitre Vascular, Inc. directly.

Affected Products

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

Quantity: 65,977 units

Why Was This Recalled?

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

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About LeMaitre Vascular, Inc.

LeMaitre Vascular, Inc. has 69 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report