Recall Z-0034-2026 ยท LXA Tissue Graft Of 6mm And Greater
LeMaitre Vascular, Inc.
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;
| Date | Oct 2, 2025 (initiated Sep 2, 2025) |
| Status | Open, Classified |
| 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. |
| Root cause | Nonconforming Material/Component |
| Action | On September 2, 2025 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 and return attached response form. 3. If the product has been implanted, graft explantation/patient intervention is NOT required. 4. When a recalled device has been returned to LeMaitre Vascular, a replacement device will be provided. 5. If you have transferred devices to another facility, please forward a copy of this recall letter to them. If you have any questions, co |
| Quantity | 28 units |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.