Recall archive / FDA device enforcement
Artegraft Collagen Vascular Graft. Model/Catalog/Part Numbers: AG630M, AG636M, AG730M, AG740M, AG845M. The Artegraft ... — FDA record Z-0072-2026
Reported ongoing
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date Aug 25, 2025. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- 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.
- Reason
- Devices were distributed with incorrect label without CE and UKCA mark, missing patient leaflet and patient implant card.
- Classification
- Class II
- Recalling firm
- LeMaitre Vascular, Inc.
- Quantity
- 10 units
- Agency-reported status
- Ongoing
- Source record identifier
- Z-0072-2026
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | 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. |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
No US distribution. International distribution to Great Britian and Switzerland.
No US distribution state could be established from this record. Check the official notice.
Dates in the source
- Report date
- Oct 15, 2025
- Recall initiation date
- Aug 25, 2025
- Center classification date
- Oct 8, 2025
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.