Artegraft Collagen Vascular Graft. Model/Catalog/Part Numbers: AG630M, AG636M, AG730M, AG740M, AG845M. The Artegraft is
FDA device recall Z-0072-2026 · posted 2025-10-08 · Open, Classified
Recall details
- Recalling firm
- LeMaitre Vascular, Inc.
- Reason for recall
- Devices were distributed with incorrect label without CE and UKCA mark, missing patient leaflet and patient implant card.
- Action taken
- LeMaitre Vascular notified consignees on about 08/25/2025 via letter. Consignees were instructed to identify any affected units in inventory, quarantine those affected units, and arrange for their return. If the product has been implanted, graft explantation/patient intervention is not required. Consignees were also instructed to notify all consignees/customers who should be aware and where affected product has been transferred. Consignees were requested to complete and return the Customer Reply Form. Distributors were requested to indicate that they have quarantine affected units in stock and notified all customers who have received the product.
- Root cause
- Process control
- Status
- Open, Classified
- Product code
- LXA
- Quantity affected
- 10 units
- Distribution
- No US distribution. International distribution to Great Britian and Switzerland.
- Date initiated
- 2025-08-25
- Date posted
- 2025-10-08
- Location
- North Brunswick, NJ
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