Drugs & medicalClass II

LeMaitre Vascular, Inc. recalls The Chevalier Valvulotome is a device used to disrupt the valves of veins which are to be used as grafts in the in situ or non-reversed…

Burrs (molding flash) on the cutter may tear the harvested vien

Read the official notice →
Date
2023-09-06
Country
United States
Brand
LeMaitre Vascular
Product
The Chevalier Valvulotome is a device used to disrupt the valves of veins which are to be used as grafts in the in situ or non-reversed…
Classification
Class II
Units
International distribution to the countries of Belgium, France, Germany, and…
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 Details may be shortened or out of date; the official notice is the authoritative source.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

  1. Check the product name, strength and lot number against the official notice.
  2. Do not stop a prescribed medicine without talking to your doctor or pharmacist first.
  3. 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

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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…

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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)…

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  7. 2025-05-21
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    LeMaitre Vascular, Inc. recalls Pruitt Occlusion Catheter. Catalog Numbers: 2103-36, 2103-46, 2103-56, E2103-36, E2103-46, E2103-56

    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 →
  9. 2024-05-22
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    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.

    FDA · DeviceLeMaitre Vascular, Inc.Worldwide distribution - US Nationwide and the countries of Australia, Canada,…Official notice →
  11. 2022-11-23
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    LeMaitre Vascular, Inc. recalls TufTex Embolectomy Catheter, Model No. This catheter has a latex balloon and a single lumen extrusion. It is inserted using a guidewire…

    Three lots tied by two trainees were released without performing the required pull test. If tied with inadequate strength, the proximal ligature could slip toward the tip of the catheter and block the inflation hole,…

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