LeMaitre Vascular, Inc.: Medical Device Recall in 2025 - (Recall #: Z-0072-2026)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2025.

Data Source: FDA.

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.

Product Classification:

Class II

Date Initiated: August 25, 2025

Date Posted: October 15, 2025

Recall Number: Z-0072-2026

Event ID: 97567

Reason for Recall:

Devices were distributed with incorrect label without CE and UKCA mark, missing patient leaflet and patient implant card.

Status: Ongoing

Product Quantity: 10 units

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.

Distribution Pattern:

No US distribution. International distribution to Great Britian and Switzerland.

Voluntary or Mandated:

Voluntary: Firm initiated