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;
Recall
- Recall Number
- Z-0034-2026
- Event Number
- 97518
- Firm
- LeMaitre Vascular, Inc.
- FEI Number
- 1000121696
- Product Code
- LXA
- Status
- Open, Classified
- Root Cause
- Nonconforming Material/Component
- Initiated
- September 2, 2025
- Posted
- October 2, 2025
- Address
- 206 N Center Dr, North Brunswick, NJ, 08902-4246
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;
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.
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; [email protected]; 732-422-8333 Monday through Friday, 8:00 AM to 4:30 PM, Eastern Time.
US Nationwide distribution in the states of CA, CT, FL, GA, IL, MA, MS, NC, ND, NJ, NY, OK, PA, TN, TX, VA, WA.
28 units