LeMaitre Vascular, Inc. — Artegraft Collagen Vascular Graft. Model/Catalog/Part Numbers: AG630M, AG636M, AG730M, AG740M, AG845M. The Artegraft is intended to serve as a substitute conduit for b
⚠️ Devices were distributed with incorrect label without CE and UKCA mark, missing patient leaflet and patient implant card.
Is this relevant to me?
- Geography
- US
- Source agency
- FDA
- Category
- Health
- Published
- August 25, 2025
No US distribution. International distribution to Great Britian and Switzerland.
What's affected?
- Product
- Artegraft Collagen Vascular Graft. Model/Catalog/Part Numbers: AG630M, AG636M, AG730M, AG740M, AG845M. The Artegraft is intended to serve as a substitute conduit for blood where bypass or replacement of occluded or diseased arterial segments is required or to establish a conduit for hemodialysis.
- Lot code
- ):
Additional details
Model/Catalog/Part Number, UDI-DI (lot Numbers): 1. AG630M, 00316837000015 (24H361-021, 24H361-022, 24HH359-016). 2. AG636M, 00316837000022 (24H380-009). 3. AG730M, 00316837000060 (24H380-014, 24H380-004). 4. AG740M, 00316837000084 (24H380-003, 24H380-002). 5. AG845M, 00316837000138 (24HH350-017, 24HH359-011). Expiration date: 28 Jul 2027.
What should I do?
Recommended action
Class II recall. Voluntary: Firm initiated Quantity affected: 10 units.
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