Home › Device types › LXA
Tissue Graft Of 6mm And Greater
FDA product code LXA · Class 3 · Unknown
26
Registered devices
184
Adverse events
4
Recalls
0
510(k) clearances
Devices with this code
Artegraft Vascular Graft — Lemaitre Vascular, Inc.Artegraft Vascular Graft — Lemaitre Vascular, Inc.Artegraft Vascular Graft — Lemaitre Vascular, Inc.Artegraft Vascular Graft — Lemaitre Vascular, Inc.Artegraft Vascular Graft — Lemaitre Vascular, Inc.ProCol Biologic Vascular Graft — Lemaitre Vascular, Inc.Artegraft Vascular Graft — Lemaitre Vascular, Inc.ProCol Biologic Vascular Graft — Lemaitre Vascular, Inc.ProCol Vascular Bioprosthesis — Hancock Jaffe Laboratories, Inc.Artegraft Vascular Graft — Lemaitre Vascular, Inc.Artegraft Vascular Graft — Lemaitre Vascular, Inc.Artegraft Vascular Graft — Lemaitre Vascular, Inc.Artegraft Vascular Graft — Lemaitre Vascular, Inc.Artegraft Vascular Graft — Lemaitre Vascular, Inc.Artegraft Vascular Graft — Lemaitre Vascular, Inc.ProCol Biologic Vascular Graft — Lemaitre Vascular, Inc.Artegraft Vascular Graft — Lemaitre Vascular, Inc.Artegraft Vascular Graft — Lemaitre Vascular, Inc.Artegraft Vascular Graft — Lemaitre Vascular, Inc.Artegraft Vascular Graft — Lemaitre Vascular, Inc.Artegraft Vascular Graft — Lemaitre Vascular, Inc.ProCol Vascular Bioprosthesis — Hancock Jaffe Laboratories, Inc.Artegraft Vascular Graft — Lemaitre Vascular, Inc.ProCol Biologic Vascular Graft — Lemaitre Vascular, Inc.
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-02-10 | LeMaitre Vascular, Inc. | Labeling mix-up resulting in the incorrect lot outer packaging of product. |
| 2025-09-25 | LeMaitre Vascular, Inc. | The device was incorrectly packed in the wrong size labeled outer packaging. |
| 2025-09-02 | LeMaitre Vascular, Inc. | The bovine carotid arteries used to produce the impacted grafts from affected lots were sourced using raw material from a supplier that had not been reviewed an |
| 2025-08-25 | LeMaitre Vascular, Inc. | Devices were distributed with incorrect label without CE and UKCA mark, missing patient leaflet and patient implant card. |
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