LeMaitre Vascular, Inc. recalls 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)…
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.
Read the official notice →- Date
- 2025-10-08
- Country
- United States
- Brand
- LeMaitre Vascular
- Product
- 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)…
- Classification
- Class II
- Units
- US Nationwide distribution in the states of CA, CT, FL, GA, IL, MA, MS, NC,…
- Category
- Drugs & medical
- Source
- FDA · Device
Copied automatically from the US Food and Drug Administration. Details may be shortened or out of date; the official notice is the authoritative source. Disclaimer
What to do
- Check the product name, strength and lot number against the official notice.
- Do not stop a prescribed medicine without talking to your doctor or pharmacist first.
- Ask the pharmacy or supplier about a replacement or refund.
General guidance from Recall Atlas. The official notice from the US Food and Drug Administration has the exact models, batch codes and remedy, and it takes priority.
More LeMaitre Vascular recalls
- 2026-03-25
USLeMaitre Vascular, Inc. recalls Artegraft Vascular Graft; REF#: AG740;
Labeling mix-up resulting in the incorrect lot outer packaging of product.
- 2025-10-29
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LeMaitre Vascular, Inc. recalls Artegraft¿ Collagen Vascular Graft; REF: AG1015;
The device was incorrectly packed in the wrong size labeled outer packaging.
- 2025-10-15
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LeMaitre Vascular, Inc. recalls Artegraft Collagen Vascular Graft. Model/Catalog/Part Numbers: AG630M, AG636M, AG730M, AG740M, AG845M. The Artegraft is intended to serve…
Devices were distributed with incorrect label without CE and UKCA mark, missing patient leaflet and patient implant card.
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FDA · DeviceLeMaitre Vascular, Inc.Worldwide distribution - US Nationwide and the countries of Australia, Canada,…Official notice → - 2023-09-06
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W L Gore & Associates, Inc. recalls GORE ACUSEAL Vascular Graft, REF: ECH050020J, ECH050020W, ECH050050J, ECH050050W, ECH060010A, ECH060020A, ECH060020J, ECH060020W,…
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