Vascular Graft Recall: Artegraft Vascular Grafts
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 |
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.
How to identify the recalled item
| Lot / date codes | 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; |
|---|---|
| Lot / date codes | REF#: AG740; UDI-DI: 00316837000299; Serial Number: 24GG298-022; Expiration Date: 28Jun2027; |
These are the identifiers FDA published for this recall. Most recall notices list no UPC or model number at all — if the code on your item is not shown here, that does not mean the item is excluded. Check the official notice, or contact the company.
Other vascular graft recalls
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.