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.

26–50 of 70

  • ModerateFDA (Devices)·Z-1453-2017·2017-03-22

    LeMaitre Vascular Catheter Recalled for Missing Latex Warning Symbol

    LeMaitre Vascular is recalling 46 units of 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 with Introducer (paper IFU) REF# 2401-53
    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
  • ModerateFDA (Devices)·Z-2543-2016·2016-08-24

    LeMaitre Vascular Recalls 1.5 mm HYDRO LeMaitre Valvulotome Devices

    LeMaitre Vascular is recalling 1,992 units of the 1.5 mm HYDRO LeMaitre Valvulotome because the wire may detach at the handle, rendering the device inoperable.

    Product
    1.5 mm HYDRO LeMaitre Valvulotome, 98 cm, Sterile REF # 1009-00 Product Usage: The HYDRO LeMaitre Valvulotome is intended for the treatment of vascular disorders and more particularly for excising or disrupting venous valves
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2544-2016·2016-08-24

    LeMaitre Vascular Recalls 1.5 mm HYDRO Valvulotome Due to Wire Detachment

    LeMaitre Vascular is recalling 380 units of the 1.5 mm HYDRO LeMaitre Valvulotome because the wire may detach, rendering the device inoperable.

    Product
    1.5 mm HYDRO LeMaitre Valvulotome without LeMills, 98 cm. Sterile REF# 1009-00J Product Usage: The HYDRO LeMaitre Valvulotome is intended for the treatment of vascular disorders and more particularly for excising or disrupting venous valves
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2545-2016·2016-08-24

    LeMaitre Vascular Recalls 1.5 mm HYDRO LeMaitre Valvulotome Devices

    LeMaitre Vascular is recalling 50 units of the 1.5 mm HYDRO LeMaitre Valvulotome because the wire may detach, rendering the device inoperable.

    Product
    1.5 mm HYDRO LeMaitre Valvulotome, 40 cm. Sterile REF # 1010-00 Product Usage: The HYDRO LeMaitre Valvulotome is intended for the treatment of vascular disorders and more particularly for excising or disrupting venous valves
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2287-2016·2016-08-03

    LeMaitre Vascular Recalls Anastoclip Universal Clip Remover for Mislabeling

    LeMaitre Vascular is recalling 39 units of the Anastoclip Universal Clip Remover because marketing materials incorrectly stated the device could be used for dura closure.

    Product
    AnastoCiip Universal Clip Remover (1Each} REF# 4001-04 The Anastoclip Clip applier consists of a rotating shaft and an integral cartridge containing titanium clips. The Anastoclip Universal Clip Remover is intended to remove Anastoclip AC Clips as necessary. It is an access
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2288-2016·2016-08-03

    LeMaitre Vascular Recalls Anastoclip Universal Clip Remover for Mislabeling

    LeMaitre Vascular is recalling 55 units of the Anastoclip Universal Clip Remover because marketing materials incorrectly stated the device could be used for dura closure.

    Product
    AnastoCiip Universal Clip Remover (6 Pack} REF# e4001-00 The Anastoclip Clip applier consists of a rotating shaft and an integral cartridge containing titanium clips. The Anastoclip Universal Clip Remover is intended to remove Anastoclip AC Clips as necessary. It is an acce
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2283-2016·2016-08-03

    LeMaitre Vascular Recalls Anastoclip AC Clips Due to Mislabeling

    LeMaitre Vascular is recalling 256 units of Anastoclip AC Clips because marketing materials incorrectly stated they could be used for dura closure.

    Product
    Anastoclip AC 8cm 35 Clips (1 Each} Medium REF # 4000-06 The Anastoclip Clip applier consists of a rotating shaft and an integral cartridge containing titanium clips. The Anastoclip Universal Clip Remover is intended to remove Anastoclip AC Clips as necessary. It is an acces
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2289-2016·2016-08-03

    LeMaitre Vascular Recalls Anastoclip Universal Clip Remover for Mislabeling

    LeMaitre Vascular is recalling 20 units of the Anastoclip Universal Clip Remover because marketing materials incorrectly stated the device could be used for dura closure, while it is only intended for cardiovascular use.

    Product
    AnastoCiip Universal Clip Remover (1Each} REF# e4001-04 The Anastoclip Clip applier consists of a rotating shaft and an integral cartridge containing titanium clips. The Anastoclip Universal Clip Remover is intended to remove Anastoclip AC Clips as necessary. It is an access
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2284-2016·2016-08-03

    LeMaitre Vascular Recalls AnastoClip AC Clips Due to Mislabeling

    LeMaitre Vascular is recalling 471 units of AnastoClip AC Clips because marketing materials incorrectly suggested they could be used for dura closure.

    Product
    AnastoClip AC 8cm 35 Clips (1 Each} Large REF # 4000-07 The Anastoclip Clip applier consists of a rotating shaft and an integral cartridge containing titanium clips. The Anastoclip Universal Clip Remover is intended to remove Anastoclip AC Clips as necessary. It is an acces
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2286-2016·2016-08-03

    LeMaitre Vascular Recalls Anastoclip Universal Clip Remover for Mislabeling

    LeMaitre Vascular is recalling the Anastoclip Universal Clip Remover because marketing materials incorrectly stated the device could be used for dura closure, though it is only intended for cardiovascular use.

    Product
    AnastoCiip Universal Clip Remover (6 Pack} REF# 4001-00 The Anastoclip Clip applier consists of a rotating shaft and an integral cartridge containing titanium clips. The Anastoclip Universal Clip Remover is intended to remove Anastoclip AC Clips as necessary. It is an acce
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2285-2016·2016-08-03

    LeMaitre Vascular Recalls Anasto AC Closure System for Mislabeling

    LeMaitre Vascular is recalling 170 units of the Anasto AC Closure System because marketing materials incorrectly stated the device could be used for dura closure.

    Product
    Anasto AC Closure System and Anasto Universal Clip Remover- Anasto AC 8cm 25 Clips (1 Each} X-Large REF # 4000-08 The Anastoclip Clip applier consists of a rotating shaft and an integral cartridge containing titanium clips. The Anastoclip Universal Clip Remover is intend
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0382-2016·2015-12-16

    LeMaitre Over-the-Wire Embolectomy Catheter Recalled for Packaging Sterility Risk

    LeMaitre Vascular is recalling 4,315 Over-the-Wire Embolectomy Catheters due to a manufacturing defect that may compromise packaging sterility.

    Product
    LeMaitre Over-the-Wire Embolectomy Catheter 7F, 80cm, Model 1654-78 and e1654-78. Indicated for the removal of arterial emboli and thrombi.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0380-2016·2015-12-16

    LeMaitre Over-the-Wire Embolectomy Catheter Recall for Packaging Defect

    LeMaitre Vascular is recalling Over-the-Wire Embolectomy Catheters due to a manufacturing issue that may compromise sterility.

    Product
    LeMaitre Over-the-Wire Embolectomy Catheter 4F, 80cm, Model 1651-48 and e1654-48. Indicated for the removal of arterial emboli and thrombi.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0384-2016·2015-12-16

    LeMaitre Over-the-Wire Embolectomy Catheter Recalled for Packaging Defect

    LeMaitre Vascular is recalling 4,315 Over-the-Wire Embolectomy Catheters due to a manufacturing issue that could compromise sterility.

    Product
    LeMaitre Over-the-Wire Embolectomy Catheter 6F, 40 cm, Model e-1651-64. Indicated for the removal of arterial emboli and thrombi.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0378-2016·2015-12-16

    LeMaitre Over-the-Wire Embolectomy Catheter Recalled for Packaging Defect

    LeMaitre Vascular is recalling 4,315 Over-the-Wire Embolectomy Catheters due to a manufacturing issue that may compromise sterility.

    Product
    LeMaitre Over-the-Wire Embolectomy Catheter 3F, 40cm, Model 1651-34 and e1651-34. Indicated for the removal of arterial emboli and thrombi.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0388-2016·2015-12-16

    LeMaitre Embolectomy Catheter Recalled for Packaging Sterility Risk

    LeMaitre Vascular is recalling 4,315 embolectomy catheters worldwide due to a manufacturing defect that may compromise packaging sterility.

    Product
    LeMaitre Single Lumen Embolectomy Catheter 5F, 80 cm, Model 1601-58 and e1601-58. Indicated for the removal of arterial emboli and thrombi.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0385-2016·2015-12-16

    LeMaitre Over-the-Wire Embolectomy Catheter Recalled for Packaging Sterility Risk

    LeMaitre Vascular is recalling 4,315 Over-the-Wire Embolectomy Catheters due to a manufacturing issue that may compromise packaging sterility.

    Product
    LeMaitre Over-the-Wire Embolectomy Catheter 6F, 80 cm, Model e-1651-68. Indicated for the removal of arterial emboli and thrombi.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0383-2016·2015-12-16

    LeMaitre Embolectomy Catheter Recalled for Packaging Sterility Risk

    LeMaitre Vascular is recalling Over-the-Wire Embolectomy Catheters due to a manufacturing issue that may compromise packaging sterility.

    Product
    LeMaitre Over-the-Wire Embolectomy Catheter 5F Plus, 40 cm, Model e1651-84. Indicated for the removal of arterial emboli and thrombi.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0390-2016·2015-12-16

    LeMaitre NovaSil Embolectomy Catheter Recalled for Packaging Sterility Risk

    LeMaitre Vascular is recalling NovaSil Embolectomy Catheters due to a manufacturing issue that could compromise packaging sterility.

    Product
    LeMaitre NovaSil Silicone Single Lumen Embolectomy Catheter 2F, 60 cm, Model e1801-26. Indicated for the removal of arterial emboli and thrombi.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0389-2016·2015-12-16

    LeMaitre NovaSil Silicone Embolectomy Catheter Recalled for Packaging Defect

    LeMaitre Vascular is recalling 4,315 units of NovaSil Silicone Embolectomy Catheters due to a manufacturing issue that may compromise sterility.

    Product
    LeMaitre NovaSil Silicone Single Lumen Embolectomy Catheter 6F, 80 cm, Model 1601-68. Indicated for the removal of arterial emboli and thrombi.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0387-2016·2015-12-16

    LeMaitre Embolectomy Catheter Recalled for Packaging Sterility Risk

    LeMaitre Vascular is recalling Single Lumen Embolectomy Catheters due to a manufacturing defect that may compromise packaging sterility.

    Product
    LeMaitre Single Lumen Embolectomy Catheter 4F, 80 cm, Model 1601-48 and e1601-48. Indicated for the removal of arterial emboli and thrombi.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0381-2016·2015-12-16

    LeMaitre Over-the-Wire Embolectomy Catheter Recalled for Packaging Defect

    LeMaitre Vascular is recalling 4,315 Over-the-Wire Embolectomy Catheters due to a manufacturing issue that may compromise sterility.

    Product
    LeMaitre Over-the-Wire Embolectomy Catheter 5F Plus, 80cm, Model 1651-88 and e1654-88. Indicated for the removal of arterial emboli and thrombi.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0379-2016·2015-12-16

    LeMaitre Embolectomy Catheter Recalled for Packaging Sterility Risk

    LeMaitre Vascular is recalling 4,315 Over-the-Wire Embolectomy Catheters worldwide due to a manufacturing defect that may compromise sterility.

    Product
    LeMaitre Over-the-Wire Embolectomy Catheter 3F, 80cm, Model 1651-38. Indicated for the removal of arterial emboli and thrombi.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0386-2016·2015-12-16

    LeMaitre Embolectomy Catheter Recalled for Packaging Sterility Risk

    LeMaitre Vascular is recalling specific embolectomy catheters because a manufacturing defect could compromise sterility.

    Product
    LeMaitre Single Lumen Embolectomy Catheter 3F, 80 cm, Model 1601-38 and e1601-38. Indicated for the removal of arterial emboli and thrombi.
    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.