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.
Read the official notice →- Date
- 2025-10-15
- Country
- United States
- Brand
- LeMaitre Vascular
- Product
- Artegraft Collagen Vascular Graft. Model/Catalog/Part Numbers: AG630M, AG636M, AG730M, AG740M, AG845M. The Artegraft is intended to serve…
- Classification
- Class II
- Units
- No US distribution. International distribution to Great Britian and Switzerland.
- 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 Details may be shortened or out of date; the official notice is the authoritative source.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
- 2026-10-14
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FDA · DeviceLeMaitre Vascular, Inc.US Nationwide distribution in the states of CA, FL, GA, KY, LA, NJ, OH, PA, SC.Official notice →- 2026-03-25
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LeMaitre 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.
- 2025-10-08
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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.
FDA · DeviceLeMaitre Vascular, Inc.US Nationwide distribution in the states of CA, CT, FL, GA, IL, MA, MS, NC,…Official notice → - 2025-05-21
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During internal product testing, it was observed that some packages to have incomplete seals (sterile barrier).
FDA · DeviceLeMaitre Vascular, Inc.Nationwide distribution. International distribution to ARGENTINA, AUSTRALIA,…Official notice → - 2024-05-22
- US
LeMaitre Vascular, Inc. recalls Syntel Silicone Thrombectomy Catheter, Sterile, Rx Only. Used in vascular grafts and peripheral venous thrombectomies.
The guide tip can become damaged and result in the tip detaching.
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Other drugs & medical recalls in the United States
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Potential for the lid of the catheter connector to be in the incorrect position.
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Inpeco S.A. recalls FlexLab X (FXX) System. Potassium Test System. in vitro diagnostic
The FlexLab X System Sample Integrity Module (SIM) includes function that determines the hemolysis, icterus, and lipemia (HIL) in blood samples. This function has not been evaluated for safety and effectiveness by the…
- US
Inpeco S.A. recalls FlexLab (FLX) System. Potassium Test System. in vitro diagnostic
The FlexLab System Sample Integrity Module (SIM) includes function that determines the hemolysis, icterus, and lipemia (HIL) in blood samples. This function has not been evaluated for safety and effectiveness by the…
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Beckman Coulter Inc. recalls SYNCHRON Systems Phosphorus (PHOSm) Reagent REF: 467868 For In Vitro Diagnostic Use, Rx Only.
Specific SYNCHRON Systems Modular Chemistry Phosphorus (PHOSm REF 467868) reagent lots may fail calibration before the lot expiration date which causes a delay in obtaining patient results.
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