LeMaitre Vascular recalled 1 Artegraft AG1015 vascular graft distributed to Arkansas hospitals after a packaging size labeling error. The packaging error could lead to using the wrong size graft during surgery. Hospitals and patients should stop using the device and follow recall instructions. See the recall letter for instructions from LeMaitre Vascular or your healthcare provider.
The device was incorrectly packed in the wrong size labeled outer packaging.
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
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Artegraft Collagen Vascular Grafts are used in vascular surgery to repair or replace blood vessels. They are implanted by healthcare professionals in hospitals.
The hazard stems from incorrect packing of the graft in the wrong size on outer packaging, which may lead to selecting an inappropriate graft size for a procedure.
This recall is not described as part of a broader industry pattern in the notice.
The immediate impact is procedural risk if a mismatched graft is used. Hospitals may need to verify inventory and communicate with surgeons about correct sizing.
Recall notices, model AG1015 details, and UDI can be found in the FDA enforcement report Z-0289-2026 and the manufacturer letters.
Recalls for medical devices commonly require 4-8 weeks for process and replacement or remediation actions.
Keep the recall letter, product labels, packaging, and any correspondence as part of clinical records
Product: Artegraft Collagen Vascular Graft Brand: LeMaitre Vascular Model: REF AG1015 UDI-DI: 00316837000343 Lot/Serial: 23MM581-016 Distribution: US to Arkansas Recall Date: 2025-09-25 Status: ACTIVE Manufacturer: LeMaitre Vascular, Inc.
No injuries or incidents have been reported.
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