Artegraft Collagen Vascular Grafts (LeMaitre) – Raw Material Issue (2025)
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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;
Brand
LeMaitre Vascular, Inc.
Lot Codes / Batch Numbers
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
Products Sold
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;
LeMaitre Vascular, Inc. is recalling Artegraft Collagen Vascular Grafts Model Numbers: (1) AG 616, (2) AG 630, (3) AG 636, (4) AG 640, (5 due to 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 r. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
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, contact Monte Nelson; mnelson@lemaitre.com; 732-422-8333 Monday through Friday, 8:00 AM to 4:30 PM, Eastern Time.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026