Class II — Potential Health Hazard

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

LeverEdge Contrast Injector: 35 cc syringe with ISO 594 female Recalled by LeMaitre Vascular, Inc. Due to The firm received a complaint regarding particulate found...

Date: April 6, 2021
Company: LeMaitre Vascular, Inc.
Status: Terminated
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

LeverEdge Contrast Injector: 35 cc syringe with ISO 594 female luer lock - Product Usage: intended to be used to perfuse contrast medias into the vessels for angiographic procedures, Catalog #: 4100-00.

Quantity: 616 units

Why Was This Recalled?

The firm received a complaint regarding particulate found in the packaging foam that could contaminate the sterile field.

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