LeMaitre Vascular recalled 28 units of Artegraft Collagen Vascular Grafts on September 2, 2025. The recall affects multiple model numbers due to unapproved sourcing of raw materials. Patients and healthcare providers must stop using the device immediately and follow recall instructions.
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.
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: Letter
The recall includes Artegraft Collagen Vascular Grafts with model numbers AG 616, AG 630, AG 636, AG 640, AG 645, AG 715, AG 730, AG 735, AG 740, AG 745, AG 750, AG 830, AG 840, AG 1015, and AG 1030. These products were distributed in various states including CA, CT, FL, GA, IL, MA, MS, NC, ND, NJ, NY, OK, PA, TN, TX, VA, and WA.
The recall stems from the use of bovine carotid arteries sourced from a supplier that lacked appropriate regulatory approval. This raises concerns about the safety and efficacy of the grafts.
No specific injury or incident counts have been reported related to this recall. However, the classification of this recall as Class II indicates a potential risk of serious injury.
Patients and healthcare providers should stop using these grafts immediately. Contact LeMaitre Vascular, Inc. or your healthcare provider for further instructions.
For more information, call LeMaitre Vascular at 1-800-XXX-XXXX or visit their website at www.lemaitrevascular.com.
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