Recall Z-0289-2026 ยท LXA Tissue Graft Of 6mm And Greater
LeMaitre Vascular, Inc.
Artegraft Collagen Vascular Graft; REF: AG1015;
| Date | Oct 23, 2025 (initiated Sep 25, 2025) |
| Status | Open, Classified |
| Reason | The device was incorrectly packed in the wrong size labeled outer packaging. |
| Root cause | Packaging change control |
| Action | 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 recalls@lemaitre.com. When a recalled device has been returned to LeMaitre Vascular, a replacement device will be provided. If you have transferred devices to another facili |
| Quantity | 1 unit |
| Distribution | US distribution to the state of: AR |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.