Lemaitre Vascular recalls
Lemaitre Vascular appears in 71 official U.S. recall notices indexed by RecallRadar, most recently on 2026-10-14.
Company names are normalized from agency data (legal suffixes removed), so related firms may appear under separate pages.
Recall summary
| Recall notices | 71 |
|---|---|
| Published | 2013-04-10 to 2026-10-14 |
| By agency | FDA Device (71) |
| By classification | Class II (52), Class I (18), Class III (1) |
| By status | terminated (59), ongoing (12) |
| Distribution named in notices | AR, CA, CO, FL, GA, KS, MN, NV, OK, PA, SC, TX, US, UT, WA, WI |
Recalls
- TufTex¿ Over-the-Wire Embolectomy Catheter
FDA Device · Class II · 2026-10-14 · Lemaitre Vascular
Reason: Devices failed in process testing related to the amount of pull force it can sustain prior to the balloon components failing. - Artegraft Vascular Graft
FDA Device · Class II · 2026-03-25 · Lemaitre Vascular
Reason: Labeling mix-up resulting in the incorrect lot outer packaging of product. - Artegraft¿ Collagen Vascular Graft
FDA Device · Class II · 2025-10-29 · Lemaitre Vascular
Reason: The device was incorrectly packed in the wrong size labeled outer packaging. - Artegraft Collagen Vascular Graft
FDA Device · Class II · 2025-10-15 · Lemaitre Vascular
Reason: Devices were distributed with incorrect label without CE and UKCA mark, missing patient leaflet and patient implant card. - 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) A…
FDA Device · Class II · 2025-10-08 · Lemaitre Vascular
Reason: 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. - TufTex Over-the-Wire Embolectomy Catheter
FDA Device · Class II · 2025-05-21 · Lemaitre Vascular
Reason: During internal product testing, it was observed that some packages to have incomplete seals (sterile barrier). - Pruitt Irrigation Occlusion Catheter
FDA Device · Class II · 2025-05-21 · Lemaitre Vascular
Reason: During internal product testing, it was observed that some packages to have incomplete seals (sterile barrier). - Pruitt Occlusion Catheter
FDA Device · Class II · 2025-05-21 · Lemaitre Vascular
Reason: During internal product testing, it was observed that some packages to have incomplete seals (sterile barrier). - Syntel Silicone Thrombectomy Catheter, Sterile, Rx Only
FDA Device · Class II · 2024-05-22 · Lemaitre Vascular
Reason: The guide tip can become damaged and result in the tip detaching. - 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 byp…
FDA Device · Class II · 2023-09-06 · Lemaitre Vascular
Reason: Burrs (molding flash) on the cutter may tear the harvested vien - TufTex Embolectomy Catheter, Model No. This catheter has a latex balloon and a single lumen extrusion
FDA Device · Class II · 2022-11-23 · Lemaitre Vascular
Reason: 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, le… - LeverEdge Contrast Injector: 35 cc syringe with ISO 594 female luer lock - Product Usage: intended to be used to perfuse contrast medias in…
FDA Device · Class II · 2021-05-12 · Lemaitre Vascular
Reason: The firm received a complaint regarding particulate found in the packaging foam that could contaminate the sterile field. - LeMaitre 5F Plus Over the Wire Embolectomy Catheter, Model Nos. 1651-84, e1651-84, 1651-88, e1651-88
FDA Device · Class I · 2020-04-08 · Lemaitre Vascular
Reason: There has been an increased trend in reports of catheters failing to deflate during use, which may ultimately lead to tip separation. - 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
FDA Device · Class II · 2019-09-11 · Lemaitre Vascular
Reason: incorrect device size being listed on the impacted device packaging - LeMaitre Vascular Pruitt F3¿-S Polyurethane Outlying Carotid Shunt, Sterile Model # 2014-10
FDA Device · Class II · 2018-11-28 · Lemaitre Vascular
Reason: Pouches from this lot are not sealed compromising the sterility - AnastoClip GC Closure System, REF# 4007-08 a closure system designed to penetrate the outer layers of tissue during the forming of an anast…
FDA Device · Class II · 2018-09-19 · Lemaitre Vascular
Reason: The wrong instructions for use (IFU) were supplied with the AnastoClip GC closure system. The IFU provided lists some indications which are not cleared by the FDA for devices distributed in the United States: 1) closure… - LeMaitre Vascular Reddick Scoop Tip Cholangiogram Stiffer Catheter (paper IFU) REF# 2401-50
FDA Device · Class II · 2017-03-22 · Lemaitre Vascular
Reason: The Contains Latex symbol was not printed onto the box label or the sterile (inner) product pouch - LeMaitre Vascular Scoop Tip Cholangiogram Catheter with Introducer (paper IFU) REF# 2401-52
FDA Device · Class II · 2017-03-22 · Lemaitre Vascular
Reason: The Contains Latex symbol was not printed onto the box label or the sterile (inner) product pouch - LeMaitre Vascular Reddick Cholangiogram Catheter with introducer(eIFU) REF # e2400-52
FDA Device · Class II · 2017-03-22 · Lemaitre Vascular
Reason: The Contains Latex symbol was not printed onto the box label or the sterile (inner) product pouch - LeMaitre Vascular Reddick Scoop Tip Cholangiogram Catheter (eIFU) REF# e2401-50
FDA Device · Class II · 2017-03-22 · Lemaitre Vascular
Reason: The Contains Latex symbol was not printed onto the box label or the sterile (inner) product pouch - LeMaitre Vascular Reddick Scoop Tip Cholangiogram Catheter with Introducer (eIFU) REF# e2401-51
FDA Device · Class II · 2017-03-22 · Lemaitre Vascular
Reason: The Contains Latex symbol was not printed onto the box label or the sterile (inner) product pouch - LeMaitre Vascular Reddick Cholangiogram Catheter (eIFU) REF# e2400-50
FDA Device · Class II · 2017-03-22 · Lemaitre Vascular
Reason: The Contains Latex symbol was not printed onto the box label or the sterile (inner) product pouch - LeMaitre Vascular Reddick Cholangiogram Stiffer Catheter with introducer (eIFU) REF # e2400-53
FDA Device · Class II · 2017-03-22 · Lemaitre Vascular
Reason: The Contains Latex symbol was not printed onto the box label or the sterile (inner) product pouch - LeMaitre Vascular Reddick Cholangiogram Stiffer Catheter (eIFU) REF# e2400-51
FDA Device · Class II · 2017-03-22 · Lemaitre Vascular
Reason: The Contains Latex symbol was not printed onto the box label or the sterile (inner) product pouch - LeMaitre Vascular Scoop Tip Cholangiogram Catheter with Introducer (eIFU) REF# e2401-52
FDA Device · Class II · 2017-03-22 · Lemaitre Vascular
Reason: The Contains Latex symbol was not printed onto the box label or the sterile (inner) product pouch - LeMaitre Vascular Scoop Tip Cholangiogram Catheter with Introducer (eIFU) REF# e2401-53
FDA Device · Class II · 2017-03-22 · Lemaitre Vascular
Reason: The Contains Latex symbol was not printed onto the box label or the sterile (inner) product pouch - LeMaitre Vascular Reddick Cholangiogram Stiffer Catheter with introducer (paper IFU) REF# 2401-51
FDA Device · Class II · 2017-03-22 · Lemaitre Vascular
Reason: The Contains Latex symbol was not printed onto the box label or the sterile (inner) product pouch - LeMaitre Vascular Reddick Scoop Tip Cholangiogram Stiffer Catheter with Introducer (paper IFU) REF# 2401-53
FDA Device · Class II · 2017-03-22 · Lemaitre Vascular
Reason: The Contains Latex symbol was not printed onto the box label or the sterile (inner) product pouch - 1.5 mm HYDRO LeMaitre Valvulotome, 98 cm, Sterile REF # 1009-00 Product Usage: The HYDRO LeMaitre Valvulotome is intended for the treatment…
FDA Device · Class II · 2016-08-24 · Lemaitre Vascular
Reason: Wire which deploys the loop may be come detached at the handle causing the device to be inoperable - 1.5 mm HYDRO LeMaitre Valvulotome without LeMills, 98 cm
FDA Device · Class II · 2016-08-24 · Lemaitre Vascular
Reason: Wire which deploys the loop may be come detached at the handle causing the device to be inoperable - 1.5 mm HYDRO LeMaitre Valvulotome, 40 cm
FDA Device · Class II · 2016-08-24 · Lemaitre Vascular
Reason: Wire which deploys the loop may be come detached at the handle causing the device to be inoperable - AnastoCiip Universal Clip Remover (6 Pack} REF# 4001-00 The Anastoclip Clip applier consists of a rotating shaft and an integral cartridge…
FDA Device · Class II · 2016-08-03 · Lemaitre Vascular
Reason: US marketing brochure for the AnastoClip AC Closure System states that the Anastoclip catalog numbers can be used for dura closure, but the catalog numbers are only intended for cardiovascular use. - AnastoCiip Universal Clip Remover (1Each} REF# e4001-04 The Anastoclip Clip applier consists of a rotating shaft and an integral cartridge…
FDA Device · Class II · 2016-08-03 · Lemaitre Vascular
Reason: US marketing brochure for the AnastoClip AC Closure System states that the Anastoclip catalog numbers can be used for dura closure, but the catalog numbers are only intended for cardiovascular use. - AnastoCiip Universal Clip Remover (6 Pack} REF# e4001-00 The Anastoclip Clip applier consists of a rotating shaft and an integral cartridge…
FDA Device · Class II · 2016-08-03 · Lemaitre Vascular
Reason: US marketing brochure for the AnastoClip AC Closure System states that the Anastoclip catalog numbers can be used for dura closure, but the catalog numbers are only intended for cardiovascular use. - Anastoclip AC 8cm 35 Clips (1 Each} Medium REF # 4000-06 The Anastoclip Clip applier consists of a rotating shaft and an integral cartridge…
FDA Device · Class II · 2016-08-03 · Lemaitre Vascular
Reason: US marketing brochure for the AnastoClip AC Closure System states that the Anastoclip catalog numbers can be used for dura closure, but the catalog numbers are only intended for cardiovascular use - AnastoClip AC 8cm 35 Clips (1 Each} Large REF # 4000-07 The Anastoclip Clip applier consists of a rotating shaft and an integral cartridge…
FDA Device · Class II · 2016-08-03 · Lemaitre Vascular
Reason: US marketing brochure for the AnastoClip AC Closure System states that the Anastoclip catalog numbers can be used for dura closure, but the catalog numbers are only intended for cardiovascular use. - Anasto AC Closure System and Anasto Universal Clip Remover- Anasto AC 8cm 25 Clips (1 Each} X-Large REF # 4000-08 The Anastoclip Clip appli…
FDA Device · Class II · 2016-08-03 · Lemaitre Vascular
Reason: US marketing brochure for the AnastoClip AC Closure System states that the Anastoclip catalog numbers can be used for dura closure, but the catalog numbers are only intended for cardiovascular use. - AnastoCiip Universal Clip Remover (1Each} REF# 4001-04 The Anastoclip Clip applier consists of a rotating shaft and an integral cartridge c…
FDA Device · Class II · 2016-08-03 · Lemaitre Vascular
Reason: US marketing brochure for the AnastoClip AC Closure System states that the Anastoclip catalog numbers can be used for dura closure, but the catalog numbers are only intended for cardiovascular use. - LeMaitre Single Lumen Embolectomy Catheter 3F, 80 cm, Model 1601-38 and e1601-38
FDA Device · Class II · 2015-12-16 · Lemaitre Vascular
Reason: Manufacturing issue that could cause a pinhole in the formed end of the packaging, which may lead to compromised sterility. - LeMaitre Over-the-Wire Embolectomy Catheter 7F, 80cm, Model 1654-78 and e1654-78
FDA Device · Class II · 2015-12-16 · Lemaitre Vascular
Reason: Manufacturing issue that could cause a pinhole in the formed end of the packaging, which may lead to compromised sterility. - LeMaitre Over-the-Wire Embolectomy Catheter 3F, 40cm, Model 1651-34 and e1651-34
FDA Device · Class II · 2015-12-16 · Lemaitre Vascular
Reason: Manufacturing issue that could cause a pinhole in the formed end of the packaging, which may lead to compromised sterility. - LeMaitre Over-the-Wire Embolectomy Catheter 3F, 80cm, Model 1651-38
FDA Device · Class II · 2015-12-16 · Lemaitre Vascular
Reason: Manufacturing issue that could cause a pinhole in the formed end of the packaging, which may lead to compromised sterility. - LeMaitre Over-the-Wire Embolectomy Catheter 5F Plus, 40 cm, Model e1651-84
FDA Device · Class II · 2015-12-16 · Lemaitre Vascular
Reason: Manufacturing issue that could cause a pinhole in the formed end of the packaging, which may lead to compromised sterility. - LeMaitre NovaSil Silicone Single Lumen Embolectomy Catheter 2F, 60 cm, Model e1801-26
FDA Device · Class II · 2015-12-16 · Lemaitre Vascular
Reason: Manufacturing issue that could cause a pinhole in the formed end of the packaging, which may lead to compromised sterility. - LeMaitre Over-the-Wire Embolectomy Catheter 4F, 80cm, Model 1651-48 and e1654-48
FDA Device · Class II · 2015-12-16 · Lemaitre Vascular
Reason: Manufacturing issue that could cause a pinhole in the formed end of the packaging, which may lead to compromised sterility. - LeMaitre Over-the-Wire Embolectomy Catheter 6F, 40 cm, Model e-1651-64
FDA Device · Class II · 2015-12-16 · Lemaitre Vascular
Reason: Manufacturing issue that could cause a pinhole in the formed end of the packaging, which may lead to compromised sterility. - LeMaitre Over-the-Wire Embolectomy Catheter 6F, 80 cm, Model e-1651-68
FDA Device · Class II · 2015-12-16 · Lemaitre Vascular
Reason: Manufacturing issue that could cause a pinhole in the formed end of the packaging, which may lead to compromised sterility. - LeMaitre Single Lumen Embolectomy Catheter 4F, 80 cm, Model 1601-48 and e1601-48
FDA Device · Class II · 2015-12-16 · Lemaitre Vascular
Reason: Manufacturing issue that could cause a pinhole in the formed end of the packaging, which may lead to compromised sterility. - LeMaitre Over-the-Wire Embolectomy Catheter 5F Plus, 80cm, Model 1651-88 and e1654-88
FDA Device · Class II · 2015-12-16 · Lemaitre Vascular
Reason: Manufacturing issue that could cause a pinhole in the formed end of the packaging, which may lead to compromised sterility. - LeMaitre Single Lumen Embolectomy Catheter 5F, 80 cm, Model 1601-58 and e1601-58
FDA Device · Class II · 2015-12-16 · Lemaitre Vascular
Reason: Manufacturing issue that could cause a pinhole in the formed end of the packaging, which may lead to compromised sterility.