Recall Z-0072-2026 ยท LXA Tissue Graft Of 6mm And Greater
LeMaitre Vascular, Inc.
Artegraft Collagen Vascular Graft. Model/Catalog/Part Numbers: AG630M, AG636M, AG730M, AG740M, AG845M. The Artegraft is intended to serve as a substitute conduit for blood where bypass or replacement of occluded or diseased arterial segments is required or to establish a conduit for hemodialysis.
| Date | Oct 8, 2025 (initiated Aug 25, 2025) |
| Status | Open, Classified |
| Reason | Devices were distributed with incorrect label without CE and UKCA mark, missing patient leaflet and patient implant card. |
| Root cause | Process control |
| Action | LeMaitre Vascular notified consignees on about 08/25/2025 via letter. Consignees were instructed to identify any affected units in inventory, quarantine those affected units, and arrange for their return. If the product has been implanted, graft explantation/patient intervention is not required. Consignees were also instructed to notify all consignees/customers who should be aware and where affected product has been transferred. Consignees were requested to complete and return the Customer Reply Form. Distributors were requested to indicate that they have quarantine affected units in stock |
| Quantity | 10 units |
| Distribution | No US distribution. International distribution to Great Britian and Switzerland. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.