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LeMaitre Vascular, Inc. recalls Artegraft Collagen Vascular Grafts Model Numbers: (1) AG 616, (2) AG 630, (3) AG 636, (4) AG 640, (5) AG 645, (6) AG 71
Recalled October 8, 2025 · FDA recall Z-0034-2026 · LeMaitre Vascular
Hazard
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. · FDA Class II
Units
28 units
Sold at
US Nationwide distribution in the states of CA, CT, FL, GA, IL, MA, MS, NC, ND, NJ, NY, OK, PA, TN, TX, VA, WA.
Description
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.
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;
Manufacturer(s)
LeMaitre Vascular, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →