Artegraft Vascular Graft recallZ-0289-2026 · LeMaitre Vascular, Inc. · initiated Sep 25, 2025
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from LeMaitre Vascular, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
The device was incorrectly packed in the wrong size labeled outer packaging.
FDA root cause category: Packaging change control
What the company is doing
On September 25, 2025, an "URGENT: MEDICAL DEVICE RECALL" letter was sent to the customer. Actions to be taken: Check your inventory against the list of lots in this letter. Immediately quarantine any recalled devices. Complete and return the form provided even if you have no devices in inventory. If the product has been implanted, graft explantation/patient intervention is NOT required. Scan the reply form and send it to [email protected]. When a recalled device has been returned to LeMaitre Vascular, a replacement device will be provided. If you have transferred devices to another facility, please forward a copy of this recall letter to them. If you have any questions, contact Sr. Director, Quality Affairs, via email: [email protected] or at 732-422-8333 Monday through Friday, 8:00AM to 4:30 PM, Eastern Time.
Recall details
- Recall number
- Z-0289-2026
- Status
- Open, Classified
- Initiated by the company
- Sep 25, 2025
- Posted by the FDA
- Oct 23, 2025
- Recalling firm
- LeMaitre Vascular, Inc.
- Quantity
- 1 unit
- Product code
- LXA
- Distribution
- US distribution to the state of: AR
Product description
Artegraft Collagen Vascular Graft; REF: AG1015;
Code information (models, lots, serial numbers)
REF: AG1015; UDI-DI: 00316837000343; Lot/Serial Number: 23MM581-016;
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- Artegraft Vascular Graft AG 1015Lemaitre Vascular, Inc. · Tissue Graft Of 6mm And Greater2 recalls0 reports
Product lines
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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