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;
FDA Recall Z-0034-2026 · Posted 2025-10-02
Recalling FirmLeMaitre Vascular, Inc.
Recall StatusOpen, Classified
Product CodeLXA
Date Initiated2025-09-02
Product Quantity28 units
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.
Firm 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, contact Monte Nelson; [email protected]; 732-422-8333
Monday through Friday, 8:00 AM to 4:30 PM, Eastern Time.
Root Cause
Nonconforming Material/Component
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.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.