The Recall Desk

Manufacturer

LeMaitre Vascular, Inc.

70 recalls in our database name LeMaitre Vascular, Inc. as the manufacturing or recalling firm.

What the numbers show

Total
70
Critical
5
Severe
12
Most recent
2026-03-25

Of the 70 recalls from LeMaitre Vascular, Inc. we have scored against our rubric, 5 (7%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 12 (17%) are Severe.

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

1–25 of 70

  • ModerateFDA (Devices)·Z-1574-2026·2026-03-25

    Artegraft vascular graft recalled over incorrect lot outer packaging labeling

    LeMaitre Vascular is recalling one Artegraft Vascular Graft, REF AG740, because of a labeling mix-up resulting in the incorrect lot outer packaging of the product.

    Product
    Artegraft Vascular Graft; REF#: AG740;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0072-2026·2025-10-15

    Collagen vascular grafts recalled over incorrect labels missing CE and UKCA marks

    LeMaitre Vascular is recalling 10 Artegraft Collagen Vascular Grafts distributed with an incorrect label lacking CE and UKCA marks and without the patient leaflet and implant card.

    Product
    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 c
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-0034-2026·2025-10-08

    Collagen vascular grafts recalled over unapproved bovine raw material supplier

    LeMaitre Vascular is recalling 28 Artegraft Collagen Vascular Grafts because the bovine carotid arteries used to make them came from a supplier not reviewed and approved by the appropriate regulatory authority.

    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) AG 735, (9) AG 740, (10) AG 745, (11) AG 750, (12) AG 830, (13) AG 840, (14) AG 1015, (15) AG 1030;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1750-2025·2025-05-21

    TufTex Over-the-Wire Embolectomy Catheter incomplete sterile barrier

    LeMaitre Vascular is recalling TufTex Over-the-Wire Embolectomy Catheters due to incomplete seals on some packages that compromise the sterile barrier. Affected units were distributed nationwide and internationally.

    Product
    TufTex Over-the-Wire Embolectomy Catheter. All Catalog numbers: 1651-34, 1651-38, 1651-44, 1651-48, 1651-58, 1651-64, 1651-68, 1651-78, 1651-84, 1651-88, E1651-34, E1651-38, E1651-44, E1651-48, E1651-64, E1651-68, E1651-78, E1651-84, E1651-88, 1651-44J, 1651-48J, 1651-84J, 1
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1751-2025·2025-05-21

    Pruitt Occlusion Catheter Recalled Due to Incomplete Sterile Barrier Seals

    LeMaitre Vascular is recalling Pruitt Occlusion Catheters (catalog numbers 2103-36, 2103-46, 2103-56, E2103-36, E2103-46, E2103-56) because some packages have incomplete sterile barrier seals, potentially compromising product sterility.

    Product
    Pruitt Occlusion Catheter. Catalog Numbers: 2103-36, 2103-46, 2103-56, E2103-36, E2103-46, E2103-56
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1752-2025·2025-05-21

    Pruitt Irrigation Occlusion Catheter Recalled for Incomplete Sterile Seals

    LeMaitre Vascular is recalling Pruitt Irrigation Occlusion Catheters (Catalog Numbers 2102-09, E2102-09) due to incomplete sterile barrier seals found during internal testing. The defect affects approximately 26,872 units distributed nationwide and internationally.

    Product
    Pruitt Irrigation Occlusion Catheter. Catalog Numbers: 2102-09, E2102-09.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1824-2024·2024-05-22

    Syntel Silicone Thrombectomy Catheter recalled due to guide tip detachment risk

    LeMaitre Vascular is recalling 5,604 units of Syntel Silicone Thrombectomy Catheters worldwide because the guide tip can become damaged and detach during use.

    Product
    Syntel Silicone Thrombectomy Catheter, Sterile, Rx Only. Used in vascular grafts and peripheral venous thrombectomies.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2468-2023·2023-09-06

    Chevalier Valvulotome Surgical Instrument Recalled Due to Burr Defect

    LeMaitre Vascular is recalling certain Chevalier Valvulotome surgical instruments used in vein-graft procedures due to burrs on the cutting tip that may tear the harvested vein. The recall affects 225 units distributed internationally.

    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 bypass procedure. The Chevalier Valvulotome consists of a 70 cm stainless steel shaft with two tips: 1) the cutting tip is shaped like an invert
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0228-2023·2022-11-23

    TufTex Embolectomy Catheter Recalled for Inadequate Ligature Ties

    LeMaitre Vascular recalled three lots of TufTex Embolectomy Catheters with inadequate ligature ties. The defect risks the catheter tip breaking off and becoming lodged in a blood vessel.

    Product
    TufTex Embolectomy Catheter, Model No. This catheter has a latex balloon and a single lumen extrusion. It is inserted using a guidewire or introducer. The devices affected by this recall are 3F and 4F..
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-1529-2021·2021-05-12

    LeMaitre Vascular Recalls LeverEdge Contrast Injectors Due to Packaging Particulates

    LeMaitre Vascular is recalling 616 LeverEdge Contrast Injectors because particulates in the packaging foam could contaminate the sterile field.

    Product
    LeverEdge Contrast Injector: 35 cc syringe with ISO 594 female luer lock - Product Usage: intended to be used to perfuse contrast medias into the vessels for angiographic procedures, Catalog #: 4100-00.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1567-2020·2020-04-08

    LeMaitre Embolectomy Catheter Recall for Deflation Failure and Tip Separation

    LeMaitre Vascular is recalling 5F Plus Over the Wire Embolectomy Catheters due to reports of deflation failure that may lead to tip separation.

    Product
    LeMaitre 5F Plus Over the Wire Embolectomy Catheter, Model Nos. 1651-84, e1651-84, 1651-88, e1651-88. The LeMaitre Over the Wire Embolectomy Catheter is indicated for use in the removal of emboli and thrombi during embolectomy and/or thrombectomy. It can also be used for cathe
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2448-2019·2019-09-11

    LeMaitre Aortic Occlusion Catheter Recalled for Incorrect Size Labeling

    LeMaitre Vascular is recalling 62 units of Aortic Occlusion Catheters because the packaging lists the incorrect device size.

    Product
    The LeMaitre Aortic Occlusion Catheter is a single lumen catheter with a latex balloon, it is offered in two balloon sizes: 28 mm or 45mm. The single lumen acts as the inflation lumen for the balloon and is indicated by the white stopcock. Other features include a balloon wall th
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0473-2019·2018-11-28

    LeMaitre Vascular Recalls Unsealed Polyurethane Carotid Shunts

    LeMaitre Vascular is recalling 46 units of Pruitt F3-S Polyurethane Outlying Carotid Shunts because the pouches are not sealed, compromising sterility.

    Product
    LeMaitre Vascular Pruitt F3¿-S Polyurethane Outlying Carotid Shunt, Sterile Model # 2014-10
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-3042-2018·2018-09-19

    LeMaitre AnastoClip GC Closure System Recalled for Incorrect Instructions

    LeMaitre Vascular is recalling AnastoClip GC Closure Systems because the included instructions listed uses not cleared by the FDA.

    Product
    AnastoClip GC Closure System, REF# 4007-08 a closure system designed to penetrate the outer layers of tissue during the forming of an anastomosis or closing of a vessel with possible intraluminal penetration.
    Category
    Medical Device
    Distribution
    5 states
  • HighFDA (Devices)·Z-1452-2017·2017-03-22

    LeMaitre Vascular Cholangiogram Catheter Recalled for Missing Latex Labeling

    LeMaitre Vascular is recalling 2,065 units of Scoop Tip Cholangiogram Catheters because the latex symbol was not printed on the packaging.

    Product
    LeMaitre Vascular Scoop Tip Cholangiogram Catheter with Introducer (eIFU) REF# e2401-53
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1442-2017·2017-03-22

    LeMaitre Vascular Cholangiogram Catheter Recalled for Missing Latex Labeling

    LeMaitre Vascular is recalling Reddick Cholangiogram Catheters because the latex symbol was not printed on the packaging, posing a risk to latex-allergic patients.

    Product
    LeMaitre Vascular Reddick Cholangiogram Catheter (eIFU) REF# e2400-50
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1449-2017·2017-03-22

    LeMaitre Vascular Catheter Recalled for Missing Latex Warning Label

    LeMaitre Vascular is recalling Reddick Cholangiogram Stiffer Catheters because the latex warning symbol was missing from the packaging.

    Product
    LeMaitre Vascular Reddick Cholangiogram Stiffer Catheter with introducer (paper IFU) REF# 2401-51
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1447-2017·2017-03-22

    LeMaitre Vascular Catheter Recalled for Missing Latex Warning Symbol

    LeMaitre Vascular is recalling Reddick Scoop Tip Cholangiogram Stiffer Catheters because the latex warning symbol was missing from the packaging.

    Product
    LeMaitre Vascular Reddick Scoop Tip Cholangiogram Stiffer Catheter (paper IFU) REF# 2401-50
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1446-2017·2017-03-22

    LeMaitre Vascular Cholangiogram Catheter Recalled for Missing Latex Symbol

    LeMaitre Vascular is recalling Reddick Scoop Tip Cholangiogram Catheters because the latex warning symbol was missing from the packaging.

    Product
    LeMaitre Vascular Reddick Scoop Tip Cholangiogram Catheter (eIFU) REF# e2401-50
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1444-2017·2017-03-22

    LeMaitre Vascular Cholangiogram Catheter Recalled for Missing Latex Symbol

    LeMaitre Vascular is recalling 608 Reddick Cholangiogram Catheters because the latex warning symbol was not printed on the packaging.

    Product
    LeMaitre Vascular Reddick Cholangiogram Catheter with introducer(eIFU) REF # e2400-52
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1448-2017·2017-03-22

    LeMaitre Vascular Cholangiogram Catheter Recalled for Missing Latex Symbol

    LeMaitre Vascular is recalling Reddick Scoop Tip Cholangiogram Catheters because the latex symbol was not printed on the packaging.

    Product
    LeMaitre Vascular Reddick Scoop Tip Cholangiogram Catheter with Introducer (eIFU) REF# e2401-51
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1445-2017·2017-03-22

    LeMaitre Vascular Cholangiogram Catheter Recalled for Missing Latex Labeling

    LeMaitre Vascular is recalling 250 units of Reddick Cholangiogram Stiffer Catheters because the latex warning symbol was not printed on the packaging.

    Product
    LeMaitre Vascular Reddick Cholangiogram Stiffer Catheter with introducer (eIFU) REF # e2400-53
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1450-2017·2017-03-22

    LeMaitre Vascular Scoop Tip Cholangiogram Catheter Recalled for Missing Latex Symbol

    LeMaitre Vascular is recalling 4,673 units of Scoop Tip Cholangiogram Catheters because the latex warning symbol was not printed on the packaging.

    Product
    LeMaitre Vascular Scoop Tip Cholangiogram Catheter with Introducer (eIFU) REF# e2401-52
    Category
    Medical Device
    Distribution
    Distributed nationwide

About this company

Community-sourced company facts from Wikidata, not from any recall agency. This is background on the corporate entity — it says nothing about the recall(s) listed on this page, which come from the agency source notice above.

LeMaitre Vascular (United States)

company in Burlington, United States

Country
United States
Founded
1983

Official website

Source: Wikidata (Q104480948), licensed CC0. Wikidata is community-edited and may not reflect the current corporate structure.