LeMaitre Vascular recalled 10 Artegraft Collagen Vascular Grafts on August 25, 2025, due to incorrect labeling. The devices lack CE and UKCA marks and are missing essential patient information. No distribution occurred within the U.S., but the affected products were sent to Great Britain and Switzerland.
Devices were distributed with incorrect label without CE and UKCA mark, missing patient leaflet and patient implant card.
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact LeMaitre Vascular, Inc. or your healthcare provider for instructions. Notification method: Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
The recalled models are AG630M, AG636M, AG730M, AG740M, and AG845M. These devices were distributed internationally, with no sales in the U.S. The expiration date for the grafts is July 28, 2027.
The Artegraft devices were labeled incorrectly, lacking the required CE and UKCA marks. Missing patient leaflets and implant cards can lead to improper use and potentially serious health risks.
There are no reported incidents or injuries associated with the recalled grafts. The recall is a proactive measure to ensure patient safety.
Patients and healthcare providers should cease use of the recalled grafts immediately. Contact LeMaitre Vascular, Inc. or your healthcare provider for further instructions.
For more information, contact LeMaitre Vascular at the telephone number provided in the recall notification. Additional details can be found at the FDA recall website.
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Labeling: Incorrect or Missing Lot and/or Exp Date
Labeling: Incorrect or Missing Lot and/or Exp Date
CGMP Deviations: The recalling firm filed for Chapter 11 on September 30, 2024. As a result, it cannot monitor the quality program and hence cannot assure that products meet the identity, strength, quality, and purity characteristics that they are purported or represented to possess, rendering the products adulterated.