Vascular Graft Recall: Artegraft Vascular Grafts
Announced 2026-03-25 · FDA
FDA is recalling LeMaitre Vascular Artegraft Collagen Vascular Grafts because the bovine carotid arteries used to make the grafts came from a supplier not reviewed or approved by the regulatory authority. A total of 28 units across 15 model numbers were distributed nationwide in listed states. The recall notice provides UDI-DIs and serial numbers for the affected lots, and no corrective action is specified.
| Brand | LeMaitre Vascular, Inc. |
|---|---|
| Product | 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; |
| Reason | 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. |
| Severity | moderate |
| Units affected | 1 |
| 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. |
| Agency | FDA |
| Recall / campaign no. | 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; |
WHAT YOU SHOULD DO
- If you have an Artegraft Vascular Graft from the affected models, contact your surgeon or healthcare provider to determine if your device is affected and what steps to take.
- Do not attempt to remove or modify the graft yourself; follow your clinician's guidance.
- For more information or to report concerns, contact LeMaitre Vascular or the FDA and have your device details (model/UDI/serial number) ready.
This is an automatically maintained record of an official recall notice. Details can change; always follow the official notice linked above. See all records in the Recall Database.