Class II — Potential Health Hazard

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

LeMaitre Vascular Pruitt F3¿-S Polyurethane Outlying Carotid Shunt Recalled by LeMaitre Vascular, Inc. Due to Pouches from this lot are not sealed compromising...

Date: October 1, 2018
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

LeMaitre Vascular Pruitt F3¿-S Polyurethane Outlying Carotid Shunt, Sterile Model # 2014-10

Quantity: 46 units

Why Was This Recalled?

Pouches from this lot are not sealed compromising the sterility

Where Was This Sold?

This product was distributed to 1 state: FL

Affected (1 state)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