Class II — LeMaitre Vascular, Inc.
| Recalling firm | LeMaitre Vascular, Inc. |
|---|---|
| Registered facility | LEMAITRE VASCULAR, INC. (the firm's only registered facility) |
| Classification | Class II |
| Status | Ongoing |
| Reason | Devices were distributed with incorrect label without CE and UKCA mark, missing patient leaflet and patient implant card. |
| 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. |
| Quantity | 10 units |
| Distribution | No US distribution. International distribution to Great Britian and Switzerland. |
| Initiated | 2025-08-25 |
| Classified | 2025-10-08 |
| Recall number | Z-0072-2026 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — LeMaitre Vascular, Inc. (Z-0072-2026).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/97567/
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