Z-0072-2026 Class II Ongoing
FDA device recall Z-0072-2026 was initiated by LeMaitre Vascular, Inc. on August 25, 2025 and is designated Class II. Reason for recall: Devices were distributed with incorrect label without CE and UKCA mark, missing patient leaflet and patient implant card. The recall status is ongoing. Affected quantity: 10 units.
Recall Details
- Product Type
- Devices
- Report Date
- October 15, 2025
- Initiation Date
- August 25, 2025
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 10 units
Product Description
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.
Reason for Recall
Devices were distributed with incorrect label without CE and UKCA mark, missing patient leaflet and patient implant card.
Distribution Pattern
No US distribution. International distribution to Great Britian and Switzerland.
Code Information
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.