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,…
Read the official notice →- Date
- 2022-11-23
- Country
- United States
- Brand
- LeMaitre Vascular
- Product
- TufTex Embolectomy Catheter, Model No. This catheter has a latex balloon and a single lumen extrusion. It is inserted using a guidewire or…
- Classification
- Class II
- Units
- No US distribution. Foreign distribution to United Kingdom, Germany, France,…
- 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 Details may be shortened or out of date; the official notice is the authoritative source.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
- 2025-10-29
USLeMaitre 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.
FDA · DeviceLeMaitre Vascular, Inc.No US distribution. International distribution to Great Britian and Switzerland.Official notice → - 2025-10-08
- US
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
- US
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 → - 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.
FDA · DeviceLeMaitre Vascular, Inc.Worldwide distribution - US Nationwide and the countries of Australia, Canada,…Official notice → - 2023-09-06
- US
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
FDA · DeviceLeMaitre Vascular, Inc.International distribution to the countries of Belgium, France, Germany, and…Official notice →
Other drugs & medical recalls in the United States
- 2022-11-23
- US
Baxter Healthcare Corporation recalls Hill-Rom Progressa Bed System
The compression links on impacted Progressa beds, listed in Appendix A, may bend when raising the head section. The labeling for these beds list a maximum patient weight of 500 lbs., however the bending may still occur…
FDA · DeviceBaxter Healthcare CorporationWorldwide - US Nationwide distribution in the states of AZ, CA, CO, FL, HI,…Official notice → - US
Boston Scientific Neuromodulation Corporation recalls Superion¿ Indirect Decompression System (IDS) Model Numbers and Size: 101-9808 - 8mm 01-9812 - 12mm 101-9814 - 14mm
Due to Indirect Decompression System devices exhibiting a potential for weld breakage at the spindle cap-to-main body interface. As a result of the separation of the spindle cap from the main body it may prevent proper…
FDA · DeviceBoston Scientific Neuromodulation CorporationU.S Nationwide Distribution including states of: AL, AR, AZ, CA, CO, CT, FL,…Official notice → - US
DeVilbiss Healthcare LLC recalls 125 series iGO2 Portable Oxygen Concentrator-indicated for the administration of supplemental oxygen. Models: 125D, 125D-XB
An unapproved adhesive used to manufacture the accumulator tank sub assembly (a part of the patient gas pathway)
FDA · DeviceDeVilbiss Healthcare LLCUS Distribution in states of: CA, FL, OH, MI, MN, NY, PA, and TX; and…Official notice → - US
- US
Spectranetics Corporation recalls Philips Laser System, REF: LAS-100. Used in minimally invasive interventional procedures within the cardiovascular system, and for the…
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FDA · DeviceSpectranetics CorporationUS: LA, MO, TN, CA, NC, PA, HI, AZ, CO, OK, FL, TX, MN, MI, VA, CT, NY, MD,…Official notice → - US
Carefusion 2200 Inc recalls CareFusion V.Mueller GENESIS FULL-LENGTH CONTAINER 23 X12" (58.4 X 30.5CM) 6" (15.2CM) DEEP STERRAD COMPATIBLE, REF CD3-6ST
Genesis STERRAD Reusable Rigid Sterilization Containers have not consistently met the requirements for aerosol challenge testing.
FDA · DeviceCarefusion 2200 IncUS and Australia, Bahrain, Canada, Denmark, Hong Kong, Italy, Japan, Malaysia,…Official notice →