Tissue Graft Of 6mm And Greater
FDA adverse event reports and recall history for tissue graft of 6mm and greater (product code LXA), from the public MAUDE/AEMS corpus and the live FDA recall database.
- Total reports
- 180
- Deaths
- 7
- Injuries
- 86
- Malfunctions
- 86
Reports per year
Source: FDA adverse event reports by year received, 2012–2026. Reporting paused during the 2026 MAUDE-to-AEMS transition and has since resumed.
Recent recalls
- 2026-03-19Open, ClassifiedLabeling Change Control
Artegraft Vascular Graft; REF#: AG740;
Labeling mix-up resulting in the incorrect lot outer packaging of product.
- 2025-10-23Open, ClassifiedPackaging change control
Artegraft Collagen Vascular Graft; REF: AG1015;
The device was incorrectly packed in the wrong size labeled outer packaging.
- 2025-10-08Open, ClassifiedProcess control
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.
Devices were distributed with incorrect label without CE and UKCA mark, missing patient leaflet and patient implant card.
- 2025-10-02Open, ClassifiedNonconforming Material/Component
Artegraft Collagen Vascular Grafts Model Numbers: (1) AG 616, (2) AG 630, (3) AG 636, (4) AG 640, (5) AG 645, (6) AG 715, (7) AG 730, (8) AG 735, (9) AG 740, (10) AG 745, (11) AG 750, (12) AG 830, (13) AG 840, (14) AG 1015, (15) AG 1030;
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 appropriate regulatory authority.
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