Recall Z-1574-2026 ยท LXA Tissue Graft Of 6mm And Greater
LeMaitre Vascular, Inc.
Artegraft Vascular Graft; REF#: AG740;
| Date | Mar 19, 2026 (initiated Feb 10, 2026) |
| Status | Open, Classified |
| Reason | Labeling mix-up resulting in the incorrect lot outer packaging of product. |
| Root cause | Labeling Change Control |
| Action | On February 10, 2026 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 the form at the end of this letter. Please note that you must return the form even if you have no devices in inventory. 3. If the product has been implanted, graft explantation/patient intervention is NOT required. 4. Scan the reply form and send it to recalls@lemaitre.com. 5. When a recalled device has been returned to LeMaitre Vascular, a replacement device will be prov |
| Quantity | 1 unit |
| Distribution | US Nationwide distribution in the state of IL. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.