Artegraft Vascular Graft recallZ-0034-2026 · LeMaitre Vascular, Inc. · initiated Sep 2, 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 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.
FDA root cause category: Nonconforming Material/Component
What the company is doing
On September 2, 2025 URGENT: MEDICAL DEVICE RECALL letters were sent to customers. Actions to be taken: 1. Check your inventory against the list of lots in this letter. Immediately quarantine any recalled devices. 2. Complete and return attached response form. 3. If the product has been implanted, graft explantation/patient intervention is NOT required. 4. When a recalled device has been returned to LeMaitre Vascular, a replacement device will be provided. 5. If you have transferred devices to another facility, please forward a copy of this recall letter to them. If you have any questions, contact Monte Nelson; [email protected]; 732-422-8333 Monday through Friday, 8:00 AM to 4:30 PM, Eastern Time.
Recall details
- Recall number
- Z-0034-2026
- Status
- Open, Classified
- Initiated by the company
- Sep 2, 2025
- Posted by the FDA
- Oct 2, 2025
- Recalling firm
- LeMaitre Vascular, Inc.
- Quantity
- 28 units
- Product code
- LXA
- Distribution
- US Nationwide distribution in the states of CA, CT, FL, GA, IL, MA, MS, NC, ND, NJ, NY, OK, PA, TN, TX, VA, WA.
Product description
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;
Code information (models, lots, serial numbers)
Show the full code information (1k characters)
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; UDI-DIs: (1) 00316837000213, (2) 00316837000220, (3) 00316837000237, (4) 00316837000244, (5) 00316837000251, (6) 00316837000268, (7) 00316837000275, (8) 00316837000282, (9) 00316837000299, (10) 00316837000305, (11) 00316837000312, (12) 00316837000367, (13) 00316837000329, (14) 00316837000343, (15) 00316837000350; Serial Numbers: (1) 23DD203-019, 23DD203-046, (2) 23DD203-024, 23DD203-029, (3) 23DD203-045, (4) 23DD203-018, (5) 23DD203-004, (6) 23DD203-021, 23DD203-044, 23DD203-038, 23DD203-039, 23DD203-011, 23DD203-032, 23DD203-031, 23DD203-043, (7) 23DD203-040, 23DD203-030, 23DD203-037, (8) 23DD203-035, 23DD203-033, (9) 23DD203-034, (10) 23DD203-036, (11) 23DD203-022, 23DD203-023, (12) 23DD203-017, (13) 23DD203-027, (14) 23KK498-014, (15) 23DD203-026;
Devices named in this recall
15 devices in the FDA device registry whose identifier appears in the recall's code information.
- Artegraft Vascular Graft AG 740Lemaitre Vascular, Inc. · Tissue Graft Of 6mm And Greater2 recalls5 reports
- Artegraft Vascular Graft AG 1015Lemaitre Vascular, Inc. · Tissue Graft Of 6mm And Greater2 recalls0 reports
- Artegraft Vascular Graft AG 636Lemaitre Vascular, Inc. · Tissue Graft Of 6mm And Greater1 recall5 reports
- Artegraft Vascular Graft AG 640Lemaitre Vascular, Inc. · Tissue Graft Of 6mm And Greater1 recall4 reports
- Artegraft Vascular Graft AG 730Lemaitre Vascular, Inc. · Tissue Graft Of 6mm And Greater1 recall3 reports
- Artegraft Vascular Graft AG 630Lemaitre Vascular, Inc. · Tissue Graft Of 6mm And Greater1 recall2 reports
- Artegraft Vascular Graft AG 745Lemaitre Vascular, Inc. · Tissue Graft Of 6mm And Greater1 recall2 reports
- Artegraft Vascular Graft AG 750Lemaitre Vascular, Inc. · Tissue Graft Of 6mm And Greater1 recall2 reports
- Artegraft Vascular Graft AG 616Lemaitre Vascular, Inc. · Tissue Graft Of 6mm And Greater1 recall1 report
- Artegraft Vascular Graft AG 735Lemaitre Vascular, Inc. · Tissue Graft Of 6mm And Greater1 recall1 report
- Artegraft Vascular Graft AG 645Lemaitre Vascular, Inc. · Tissue Graft Of 6mm And Greater1 recall0 reports
- Artegraft Vascular Graft AG 715Lemaitre Vascular, Inc. · Tissue Graft Of 6mm And Greater1 recall0 reports
- Artegraft Vascular Graft AG 840Lemaitre Vascular, Inc. · Tissue Graft Of 6mm And Greater1 recall0 reports
- Artegraft Vascular Graft AG 1030Lemaitre Vascular, Inc. · Tissue Graft Of 6mm And Greater1 recall0 reports
- Artegraft Vascular Graft AG 830Lemaitre Vascular, Inc. · Tissue Graft Of 6mm And Greater1 recall0 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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