Z-0034-2026 Class II Ongoing
FDA device recall Z-0034-2026 was initiated by LeMaitre Vascular, Inc. on September 2, 2025 and is designated Class II. Reason for recall: 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… The recall status is ongoing. Affected quantity: 28 units.
Recall Details
- Product Type
- Devices
- Report Date
- October 8, 2025
- Initiation Date
- September 2, 2025
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 28 units
Product Description
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;
Reason for Recall
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.
Distribution Pattern
US Nationwide distribution in the states of CA, CT, FL, GA, IL, MA, MS, NC, ND, NJ, NY, OK, PA, TN, TX, VA, WA.
Code Information
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;