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LeMaitre Vascular, Inc.
LeMaitre Vascular, Inc.: 70 FDA recall reports
Every medical device recall the FDA has published for LeMaitre Vascular, Inc.. The fault, and how the agency graded it.
70Reports
18Class I
11Ongoing
2026-03-25Most recent
18 Class I on this pageClass I means the FDA judged there was a reasonable probability of serious harm or death. Check the lot numbers against anything you hold.
What the classes mean
The FDA sorts every recall into one of three classes. The class is the whole story. It is also the part people skip.
Class II is the bulk of every list here. That matters. A long list of Class II says something different from one Class I.
By class
By year reported
Checking whether it affects you
The lot or code number is what matters. Not the product name. A recall covers
specific lots. Yours may not be one of them.
Check the code on your package against the report. The FDA keeps the current
list at fda.gov/safety/recalls.
The reports
The text below is quoted from the FDA record word for word.
Artegraft Vascular Graft; REF#: AG740;
Z-1574-2026 · Class II · reported 2026-03-25 · Ongoing
- Why it was recalled
- Labeling mix-up resulting in the incorrect lot outer packaging of product.
- Product
- Artegraft Vascular Graft; REF#: AG740;
- Where it went
- US Nationwide distribution in the state of IL.
- How much
- 1 unit
Artegraft¿ Collagen Vascular Graft; REF: AG1015;
Z-0289-2026 · Class II · reported 2025-10-29 · Ongoing
- Why it was recalled
- The device was incorrectly packed in the wrong size labeled outer packaging.
- Product
- Artegraft¿ Collagen Vascular Graft; REF: AG1015;
- Where it went
- US distribution to the state of: AR
- How much
- 1 unit
Artegraft Collagen Vascular Graft. Model/Catalog/Part Numbers: AG630M, AG636M, AG730M, AG740M, AG845M.
Z-0072-2026 · Class II · reported 2025-10-15 · Ongoing
- Why it was recalled
- Devices were distributed with incorrect label without CE and UKCA mark, missing patient leaflet and patient 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 conduit for hemodialysis.
- Where it went
- No US distribution. International distribution to Great Britian and Switzerland.
- How much
- 10 units
Artegraft Collagen Vascular Grafts Model Numbers: (1) AG 616, (2) AG 630, (3) AG 636, (4) AG 640, (5) AG 645,
Z-0034-2026 · Class II · reported 2025-10-08 · Ongoing
- Why it was recalled
- 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.
- 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;
- Where it went
- US Nationwide distribution in the states of CA, CT, FL, GA, IL, MA, MS, NC, ND, NJ, NY, OK, PA, TN, TX, VA, WA.
- How much
- 28 units
Pruitt Occlusion Catheter. Catalog Numbers: 2103-36, 2103-46, 2103-56, E2103-36, E2103-46, E2103-56
Z-1751-2025 · Class II · reported 2025-05-21 · Ongoing
- Why it was recalled
- During internal product testing, it was observed that some packages to have incomplete seals (sterile barrier).
- Product
- Pruitt Occlusion Catheter. Catalog Numbers: 2103-36, 2103-46, 2103-56, E2103-36, E2103-46, E2103-56
- Where it went
- Nationwide distribution. International distribution to ARGENTINA, AUSTRALIA, AUSTRIA, BELGIUM, BRAZIL, BULGARIA, CAMBODIA, CANADA, CHILE, COLOMBIA, COSTA RICA, CYPRUS, CZECHIA, DENMARK, DOMINICAN REPUBLIC, EGYPT, EL SALVADOR, ESTONIA, FINLAND, FRANCE, GEORGIA, GERMANY, GREECE, GUATEMALA, GUYANA, HONG KONG, HUNGARY, INDIA, INDONESIA, IRELAND, ISRAEL, ITALY, JAPAN, JORDAN, KUWAIT, LATVIA, LEBANON, LITHUANIA, MALAYSIA, MALTA, MEXICO, MONGOLIA, MOROCCO, NETHERLANDS, NEW ZEALAND, NICARAGUA, NORTH MACEDONIA, NORWAY, OMAN, PANAMA, PARAGUAY, PHILIPPINES, POLAND, QATAR, ROMANIA, RUSSIA, SAUDI ARABIA, SERBIA, SINGAPORE, SLOVAKIA, SLOVENIA, SOUTH AFRICA, SOUTH KOREA, SPAIN, SWEDEN, SWITZERLAND, TAIWAN, THAILAND, TRINIDAD AND TOBAGO, TUNISIA, TURKIYE, UNITED ARAB EMIRATES, UNITED KINGDOM, VENEZUELA, VIETNAM.
- How much
- 65,977 units
TufTex Over-the-Wire Embolectomy Catheter. All Catalog numbers: 1651-34, 1651-38, 1651-44, 1651-48, 1651-58,
Z-1750-2025 · Class II · reported 2025-05-21 · Ongoing
- Why it was recalled
- During internal product testing, it was observed that some packages to have incomplete seals (sterile barrier).
- 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, 1651-88J.
- Where it went
- Nationwide distribution. International distribution to ARGENTINA, AUSTRALIA, AUSTRIA, BELGIUM, BRAZIL, BULGARIA, CAMBODIA, CANADA, CHILE, COLOMBIA, COSTA RICA, CYPRUS, CZECHIA, DENMARK, DOMINICAN REPUBLIC, EGYPT, EL SALVADOR, ESTONIA, FINLAND, FRANCE, GEORGIA, GERMANY, GREECE, GUATEMALA, GUYANA, HONG KONG, HUNGARY, INDIA, INDONESIA, IRELAND, ISRAEL, ITALY, JAPAN, JORDAN, KUWAIT, LATVIA, LEBANON, LITHUANIA, MALAYSIA, MALTA, MEXICO, MONGOLIA, MOROCCO, NETHERLANDS, NEW ZEALAND, NICARAGUA, NORTH MACEDONIA, NORWAY, OMAN, PANAMA, PARAGUAY, PHILIPPINES, POLAND, QATAR, ROMANIA, RUSSIA, SAUDI ARABIA, SERBIA, SINGAPORE, SLOVAKIA, SLOVENIA, SOUTH AFRICA, SOUTH KOREA, SPAIN, SWEDEN, SWITZERLAND, TAIWAN, THAILAND, TRINIDAD AND TOBAGO, TUNISIA, TURKIYE, UNITED ARAB EMIRATES, UNITED KINGDOM, VENEZUELA, VIETNAM.
- How much
- 237,611 units
Pruitt Irrigation Occlusion Catheter. Catalog Numbers: 2102-09, E2102-09.
Z-1752-2025 · Class II · reported 2025-05-21 · Ongoing
- Why it was recalled
- During internal product testing, it was observed that some packages to have incomplete seals (sterile barrier).
- Product
- Pruitt Irrigation Occlusion Catheter. Catalog Numbers: 2102-09, E2102-09.
- Where it went
- Nationwide distribution. International distribution to ARGENTINA, AUSTRALIA, AUSTRIA, BELGIUM, BRAZIL, BULGARIA, CAMBODIA, CANADA, CHILE, COLOMBIA, COSTA RICA, CYPRUS, CZECHIA, DENMARK, DOMINICAN REPUBLIC, EGYPT, EL SALVADOR, ESTONIA, FINLAND, FRANCE, GEORGIA, GERMANY, GREECE, GUATEMALA, GUYANA, HONG KONG, HUNGARY, INDIA, INDONESIA, IRELAND, ISRAEL, ITALY, JAPAN, JORDAN, KUWAIT, LATVIA, LEBANON, LITHUANIA, MALAYSIA, MALTA, MEXICO, MONGOLIA, MOROCCO, NETHERLANDS, NEW ZEALAND, NICARAGUA, NORTH MACEDONIA, NORWAY, OMAN, PANAMA, PARAGUAY, PHILIPPINES, POLAND, QATAR, ROMANIA, RUSSIA, SAUDI ARABIA, SERBIA, SINGAPORE, SLOVAKIA, SLOVENIA, SOUTH AFRICA, SOUTH KOREA, SPAIN, SWEDEN, SWITZERLAND, TAIWAN, THAILAND, TRINIDAD AND TOBAGO, TUNISIA, TURKIYE, UNITED ARAB EMIRATES, UNITED KINGDOM, VENEZUELA, VIETNAM.
- How much
- 26,872 units
Syntel Silicone Thrombectomy Catheter, Sterile, Rx Only. Used in vascular grafts and peripheral venous thrombe
Z-1824-2024 · Class II · reported 2024-05-22 · Ongoing
- Why it was recalled
- The guide tip can become damaged and result in the tip detaching.
- Product
- Syntel Silicone Thrombectomy Catheter, Sterile, Rx Only. Used in vascular grafts and peripheral venous thrombectomies.
- Where it went
- Worldwide distribution - US Nationwide and the countries of Australia, Canada, and Spain.
- How much
- 5,604 units
The Chevalier Valvulotome is a device used to disrupt the valves of veins which are to be used as grafts in th
Z-2468-2023 · Class II · reported 2023-09-06 · Ongoing
- Why it was recalled
- Burrs (molding flash) on the cutter may tear the harvested vien
- 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 inverted tulip with four teeth at its base. This tip is designed to cut the vein valve cusps. 2) the other tip is atraumatic and used to test the patency and the course of the vein before the valvulotomy. The Chevalier Valvulotome is available in three tip diameters: 2.5 mm (Catalog # 40025); 3.0 mm (Catalog # 40030); and 3.5 mm (Catalog # 40035)
- Where it went
- International distribution to the countries of Belgium, France, Germany, and United Kingdom.
- How much
- 225 units
TufTex Embolectomy Catheter, Model No. This catheter has a latex balloon and a single lumen extrusion. It
Z-0228-2023 · Class II · reported 2022-11-23 · Ongoing
- Why it was recalled
- 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, leading to the risk of the tip breaking off, and potentially becoming lost in the 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..
- Where it went
- No US distribution. Foreign distribution to United Kingdom, Germany, France, Sweden, Austria, and Italy.
- How much
- 72 (OUS only)
LeverEdge Contrast Injector: 35 cc syringe with ISO 594 female luer lock - Product Usage: intended to be used
Z-1529-2021 · Class II · reported 2021-05-12 · Terminated
- Why it was recalled
- The firm received a complaint regarding particulate found in the packaging foam that 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.
- Where it went
- Worldwide distribution - US Nationwide distribution in the states of AL, CA, FL, IL, IN, KY, MA, MO, NY, OH, TN, TX and the countries of Bahamas, Belgium, France, Germany, Hong Kong, Spain.
- How much
- 616 units
Class I
LeMaitre 5F Plus Over the Wire Embolectomy Catheter, Model Nos. 1651-84, e1651-84, 1651-88, e1651-88. The L
Z-1567-2020 · Class I · reported 2020-04-08 · Ongoing
- Why it was recalled
- There has been an increased trend in reports of catheters failing to deflate during use, which may ultimately 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 catheter placement over a guidewire, vessel occlusion, fluid infusion and/or aspiration.
- Where it went
- Worldwide distribution: US (Nationwide distribution) and foreign countries of: Australia, Austria, Belgium, Bulgaria, Colombia, Costa Rica, Czech Republic, Dominican Republic, Egypt, El Salvador, Estonia, Finland, France, Germany, Georgia, Hungary, Ireland, Israel, Italy, Japan, Korea, Netherlands, New Zealand, Norway, Poland, Portugal, Qatar, Saudi Arabia, Singapore, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, United Kingdom, and Vietnam.
- How much
- 43315
The LeMaitre Aortic Occlusion Catheter is a single lumen catheter with a latex balloon, it is offered in two b
Z-2448-2019 · Class II · reported 2019-09-11 · Terminated
- Why it was recalled
- incorrect device size being listed on the impacted device packaging
- 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 thickness designed to reduce the possibility of puncture by calcium deposits, and a stop-cock to maintain balloon inflation level throughout the procedure.
- Where it went
- GERMANY FRANCE SLOVENIA SPAIN SWEDEN UK
- How much
- 62 units
LeMaitre Vascular Pruitt F3¿-S Polyurethane Outlying Carotid Shunt, Sterile Model # 2014-10
Z-0473-2019 · Class II · reported 2018-11-28 · Terminated
- Why it was recalled
- Pouches from this lot are not sealed compromising the sterility
- Product
- LeMaitre Vascular Pruitt F3¿-S Polyurethane Outlying Carotid Shunt, Sterile Model # 2014-10
- Where it went
- FL Foreign: Austalia, Korea
- How much
- 46 units
AnastoClip GC Closure System, REF# 4007-08 a closure system designed to penetrate the outer layers of tissue d
Z-3042-2018 · Class II · reported 2018-09-19 · Terminated
- Why it was recalled
- 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 of arteriotomies and veinotomies, 2) attachment of synthetic vascular prostheses, and 3) approximation of dural tissue.
- 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.
- Where it went
- Distributed to accounts in FL, NV, OK, SC, and TX.
- How much
- N/A
LeMaitre Vascular Reddick Scoop Tip Cholangiogram Stiffer Catheter with Introducer (paper IFU) REF# 2401-53
Z-1453-2017 · Class II · reported 2017-03-22 · Terminated
- Why it was recalled
- The Contains Latex symbol was not printed onto the box label or the sterile (inner) product pouch
- Product
- LeMaitre Vascular Reddick Scoop Tip Cholangiogram Stiffer Catheter with Introducer (paper IFU) REF# 2401-53
- Where it went
- Worldwide distribution. US Nationwide, AUSTRIA, BELGIUM, FRANCE, GERMANY, ITALY, LUXEMBOURG, Morocco, Saudi Arabia, Singapore, SPAIN, SWITZERLAND, UAE, and UK
- How much
- 46
LeMaitre Vascular Scoop Tip Cholangiogram Catheter with Introducer (paper IFU) REF# 2401-52
Z-1451-2017 · Class II · reported 2017-03-22 · Terminated
- Why it was recalled
- The Contains Latex symbol was not printed onto the box label or the sterile (inner) product pouch
- Product
- LeMaitre Vascular Scoop Tip Cholangiogram Catheter with Introducer (paper IFU) REF# 2401-52
- Where it went
- Worldwide distribution. US Nationwide, AUSTRIA, BELGIUM, FRANCE, GERMANY, ITALY, LUXEMBOURG, Morocco, Saudi Arabia, Singapore, SPAIN, SWITZERLAND, UAE, and UK
- How much
- 247
LeMaitre Vascular Reddick Cholangiogram Catheter with introducer(eIFU) REF # e2400-52
Z-1444-2017 · Class II · reported 2017-03-22 · Terminated
- Why it was recalled
- The Contains Latex symbol was not printed onto the box label or the sterile (inner) product pouch
- Product
- LeMaitre Vascular Reddick Cholangiogram Catheter with introducer(eIFU) REF # e2400-52
- Where it went
- Worldwide distribution. US Nationwide, AUSTRIA, BELGIUM, FRANCE, GERMANY, ITALY, LUXEMBOURG, Morocco, Saudi Arabia, Singapore, SPAIN, SWITZERLAND, UAE, and UK
- How much
- 608
LeMaitre Vascular Reddick Cholangiogram Stiffer Catheter with introducer (eIFU) REF # e2400-53
Z-1445-2017 · Class II · reported 2017-03-22 · Terminated
- Why it was recalled
- The Contains Latex symbol was not printed onto the box label or the sterile (inner) product pouch
- Product
- LeMaitre Vascular Reddick Cholangiogram Stiffer Catheter with introducer (eIFU) REF # e2400-53
- Where it went
- Worldwide distribution. US Nationwide, AUSTRIA, BELGIUM, FRANCE, GERMANY, ITALY, LUXEMBOURG, Morocco, Saudi Arabia, Singapore, SPAIN, SWITZERLAND, UAE, and UK
- How much
- 250
LeMaitre Vascular Reddick Scoop Tip Cholangiogram Catheter (eIFU) REF# e2401-50
Z-1446-2017 · Class II · reported 2017-03-22 · Terminated
- Why it was recalled
- The Contains Latex symbol was not printed onto the box label or the sterile (inner) product pouch
- Product
- LeMaitre Vascular Reddick Scoop Tip Cholangiogram Catheter (eIFU) REF# e2401-50
- Where it went
- Worldwide distribution. US Nationwide, AUSTRIA, BELGIUM, FRANCE, GERMANY, ITALY, LUXEMBOURG, Morocco, Saudi Arabia, Singapore, SPAIN, SWITZERLAND, UAE, and UK
- How much
- 4673
LeMaitre Vascular Scoop Tip Cholangiogram Catheter with Introducer (eIFU) REF# e2401-52
Z-1450-2017 · Class II · reported 2017-03-22 · Terminated
- Why it was recalled
- The Contains Latex symbol was not printed onto the box label or the sterile (inner) product pouch
- Product
- LeMaitre Vascular Scoop Tip Cholangiogram Catheter with Introducer (eIFU) REF# e2401-52
- Where it went
- Worldwide distribution. US Nationwide, AUSTRIA, BELGIUM, FRANCE, GERMANY, ITALY, LUXEMBOURG, Morocco, Saudi Arabia, Singapore, SPAIN, SWITZERLAND, UAE, and UK
- How much
- 4673
LeMaitre Vascular Reddick Scoop Tip Cholangiogram Catheter with Introducer (eIFU) REF# e2401-51
Z-1448-2017 · Class II · reported 2017-03-22 · Terminated
- Why it was recalled
- The Contains Latex symbol was not printed onto the box label or the sterile (inner) product pouch
- Product
- LeMaitre Vascular Reddick Scoop Tip Cholangiogram Catheter with Introducer (eIFU) REF# e2401-51
- Where it went
- Worldwide distribution. US Nationwide, AUSTRIA, BELGIUM, FRANCE, GERMANY, ITALY, LUXEMBOURG, Morocco, Saudi Arabia, Singapore, SPAIN, SWITZERLAND, UAE, and UK
- How much
- 2065
LeMaitre Vascular Reddick Scoop Tip Cholangiogram Stiffer Catheter (paper IFU) REF# 2401-50
Z-1447-2017 · Class II · reported 2017-03-22 · Terminated
- Why it was recalled
- The Contains Latex symbol was not printed onto the box label or the sterile (inner) product pouch
- Product
- LeMaitre Vascular Reddick Scoop Tip Cholangiogram Stiffer Catheter (paper IFU) REF# 2401-50
- Where it went
- Worldwide distribution. US Nationwide, AUSTRIA, BELGIUM, FRANCE, GERMANY, ITALY, LUXEMBOURG, Morocco, Saudi Arabia, Singapore, SPAIN, SWITZERLAND, UAE, and UK
- How much
- 403
LeMaitre Vascular Scoop Tip Cholangiogram Catheter with Introducer (eIFU) REF# e2401-53
Z-1452-2017 · Class II · reported 2017-03-22 · Terminated
- Why it was recalled
- The Contains Latex symbol was not printed onto the box label or the sterile (inner) product pouch
- Product
- LeMaitre Vascular Scoop Tip Cholangiogram Catheter with Introducer (eIFU) REF# e2401-53
- Where it went
- Worldwide distribution. US Nationwide, AUSTRIA, BELGIUM, FRANCE, GERMANY, ITALY, LUXEMBOURG, Morocco, Saudi Arabia, Singapore, SPAIN, SWITZERLAND, UAE, and UK
- How much
- 2065
LeMaitre Vascular Reddick Cholangiogram Catheter (eIFU) REF# e2400-50
Z-1442-2017 · Class II · reported 2017-03-22 · Terminated
- Why it was recalled
- The Contains Latex symbol was not printed onto the box label or the sterile (inner) product pouch
- Product
- LeMaitre Vascular Reddick Cholangiogram Catheter (eIFU) REF# e2400-50
- Where it went
- Worldwide distribution. US Nationwide, AUSTRIA, BELGIUM, FRANCE, GERMANY, ITALY, LUXEMBOURG, Morocco, Saudi Arabia, Singapore, SPAIN, SWITZERLAND, UAE, and UK
- How much
- 5601
LeMaitre Vascular Reddick Cholangiogram Stiffer Catheter with introducer (paper IFU) REF# 2401-51
Z-1449-2017 · Class II · reported 2017-03-22 · Terminated
- Why it was recalled
- The Contains Latex symbol was not printed onto the box label or the sterile (inner) product pouch
- Product
- LeMaitre Vascular Reddick Cholangiogram Stiffer Catheter with introducer (paper IFU) REF# 2401-51
- Where it went
- Worldwide distribution. US Nationwide, AUSTRIA, BELGIUM, FRANCE, GERMANY, ITALY, LUXEMBOURG, Morocco, Saudi Arabia, Singapore, SPAIN, SWITZERLAND, UAE, and UK
- How much
- 179
LeMaitre Vascular Reddick Cholangiogram Stiffer Catheter (eIFU) REF# e2400-51
Z-1443-2017 · Class II · reported 2017-03-22 · Terminated
- Why it was recalled
- The Contains Latex symbol was not printed onto the box label or the sterile (inner) product pouch
- Product
- LeMaitre Vascular Reddick Cholangiogram Stiffer Catheter (eIFU) REF# e2400-51
- Where it went
- Worldwide distribution. US Nationwide, AUSTRIA, BELGIUM, FRANCE, GERMANY, ITALY, LUXEMBOURG, Morocco, Saudi Arabia, Singapore, SPAIN, SWITZERLAND, UAE, and UK
- How much
- 340
1.5 mm HYDRO LeMaitre Valvulotome without LeMills, 98 cm. Sterile REF# 1009-00J Product Usage: The HYDRO
Z-2544-2016 · Class II · reported 2016-08-24 · Terminated
- Why it was recalled
- Wire which deploys the loop may be come detached at the handle causing the device to be 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
- Where it went
- Worldwide Distribution - US Nationwide and in the countries of Australia, BELGIUM, BRAZIL, CANADA, Czech Republic, DENMARK, FINLAND, FRANCE, GERMANY, Italy, Japan, NETHERLANDS, Russia, Spain, SWEDEN, Switzerland, and UK.
- How much
- 380 units
1.5 mm HYDRO LeMaitre Valvulotome, 98 cm, Sterile REF # 1009-00 Product Usage: The HYDRO LeMaitre Valvul
Z-2543-2016 · Class II · reported 2016-08-24 · Terminated
- Why it was recalled
- Wire which deploys the loop may be come detached at the handle causing the device to be 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
- Where it went
- Worldwide Distribution - US Nationwide and in the countries of Australia, BELGIUM, BRAZIL, CANADA, Czech Republic, DENMARK, FINLAND, FRANCE, GERMANY, Italy, Japan, NETHERLANDS, Russia, Spain, SWEDEN, Switzerland, and UK.
- How much
- 1992 units
1.5 mm HYDRO LeMaitre Valvulotome, 40 cm. Sterile REF # 1010-00 Product Usage: The HYDRO LeMaitre Valvulo
Z-2545-2016 · Class II · reported 2016-08-24 · Terminated
- Why it was recalled
- Wire which deploys the loop may be come detached at the handle causing the device to be 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
- Where it went
- Worldwide Distribution - US Nationwide and in the countries of Australia, BELGIUM, BRAZIL, CANADA, Czech Republic, DENMARK, FINLAND, FRANCE, GERMANY, Italy, Japan, NETHERLANDS, Russia, Spain, SWEDEN, Switzerland, and UK.
- How much
- 50 units
Showing the 30 most recent of 70. The rest are searchable at the FDA enforcement report database.
Read these counts with three things in mind
A firm with more recalls usually makes more products. A contract packer runs
hundreds of lines. It will out-recall a company with one product whatever either
does. This is not a safety ranking.
Most recalls here are voluntary. A firm found its own fault and pulled the stock.
That is the system working. It lands in this database looking the same as a recall
the FDA had to push for.
Terminated means the FDA considers the recall finished. It is not a verdict.
It does not mean anyone was harmed.
Source: openFDA enforcement reports, retrieved 2026-08-05. FDA dataset last updated 2026-07-29.
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