LeMaitre Vascular, Inc.

Warning LetterOpen

Mr. George LeMaitre Chairman and CEO LeMaitre Vascular, Inc. 63 Second Ave. Burlington , MA 01803 United States glemaitre@lemaitre.comFEI 1000121696Issued Aug 11, 2025Center for Devices and Radiological Health

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Violations6

Issue DateAug 11, 2025

Product TypeMedical Devices

StatusOpen

Letter Details

Firm: LeMaitre Vascular, Inc.
Location: Mr. George LeMaitre Chairman and CEO LeMaitre Vascular, Inc. 63 Second Ave. Burlington , MA 01803 United States glemaitre@lemaitre.com
FEI Number: 1000121696
Country: United States
Issue Date: August 11, 2025
Issuing Office: Center for Devices and Radiological Health
Product Type: Medical Devices
Status: Open

Summary

LeMaitre Vascular, Inc. was cited for manufacturing Artegraft Collagen Vascular Grafts in violation of Quality System Regulation (21 CFR Part 820) requirements. FDA investigators found during a March-April 2025 inspection at the company's North Brunswick, NJ facility that the firm failed to establish and maintain procedures to prevent equipment and product contamination, including deficiencies in USP water sampling procedures for testing conductivity, Total Organic Carbon (TOC), endotoxin, and microbial contamination. The devices were determined to be adulterated due to nonconformity with current good manufacturing practices for manufacture, packing, storage, and installation.

LeMaitre Vascular, Inc. FDA Warning Letter, August 11, 2025