Home › Lemaitre Vascular, Inc. › Artegraft Vascular Graft
Artegraft Vascular Graft
Lemaitre Vascular, Inc. · Model AG 830 · UDI-DI 00316837000367
LXA
Prescription
0
510(k) clearances
184
Adverse events (7 deaths)
4
Recalls
2
Facilities
Description
7mm x 30cm
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 and approved by the ap |
| 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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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.