Recall Z-0034-2026— LeMaitre Vascular, Inc.
Class II · Ongoing
Class II FDA medical device recall by LeMaitre Vascular, Inc., initiated 2025-09-02. FDA's recall record names no specific 510(k) clearance for this event. 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;. Reason: 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..
- Recalling firm
- LeMaitre Vascular, Inc.
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2025-09-02
- Firm location
- North Brunswick, NJ, United States
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.