Class II — Potential Health Hazard

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

Artegraft Collagen Vascular Grafts Model Numbers: (1) AG 616 Recalled by LeMaitre Vascular, Inc. Due to The bovine carotid arteries used to produce the...

Date: September 2, 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

Artegraft Collagen Vascular Grafts Model Numbers: (1) AG 616, (2) AG 630, (3) AG 636, (4) AG 640, (5) AG 645, (6) AG 715, (7) AG 730, (8) AG 735, (9) AG 740, (10) AG 745, (11) AG 750, (12) AG 830, (13) AG 840, (14) AG 1015, (15) AG 1030;

Quantity: 28 units

Why Was This Recalled?

The bovine carotid arteries used to produce the impacted grafts from affected lots were sourced using raw material from a supplier that had not been reviewed and approved by the appropriate regulatory authority.

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