Is this your brand? Sign in to claim ownership.
Sign in to claim this brandLeMaitre Vascular, Inc.
United States·US-MF-000016778
Last updated September 17, 2026
About
At LeMaitre, we've dedicated our lives to innovation and research to create tools for the vascular surgeon of today and tomorrow.
From the manufacturer's own website. Source
What LeMaitre Vascular, Inc. makes
LeMaitre Vascular, Inc. manufactures vascular and biliary intervention devices, including thrombectomy balloon catheters for clot removal, animal-derived cardiovascular patches for tissue repair, and arteriovenous/carotid shunts for blood flow management. The portfolio also covers image-guided intravascular occluding balloons, reusable intraluminal artery strippers, valvulotomes for valve incision, and single-use ERCP catheters for bile duct visualization. Surgical tools like the MollRing Cutter and AnastoClip for vessel transection and anastomosis are also part of the product line.
The company’s devices are classified under FDA categories including Class I, Class II, Class IIa, and Class III, with regulatory records maintained in eudamed, FDA 510(k), and FDA UDI databases. The manufacturer is based in the United States.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Information
- Country
- United States
- Address
- 63, Second Avenue, Burlington, Massachusetts, United States
- Website
- www.lemaitre.com
- —
- [email protected]
- Phone
- +1 781-425-1735
- PRRC Contact
- Andrew Hodgkinson
- EUDAMED SRN
- US-MF-000016778
- FDA FEI Number
- 1220948
- DUNS Number
- —
Catalogue (569)
Page 12 of 12Related Companies
Authorised Representatives
Importers
Not available yet.
Notified Bodies
Not available yet.
Authorities
Not available yet.
FDA Recalls (84)
Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.
LeMaitre Vascular, Inc. has 84 recall records spanning from February 7, 2005, to February 10, 2026, with statuses recorded as open, classified, or terminated. The reasons cited include labeling discrepancies such as incorrect expiration dates, missing regulatory marks, and mislabeled product sizes; mechanical failures like detached deployment wires or cutter burrs; packaging issues affecting sterility, including incomplete seals, pinholes, and improper sealing; and reports of catheters failing to deflate properly. Some records also reference potential sterility compromises due to defective packaging and missing documentation.
AI-generated summary of the recall records listed below. It describes what the records state and is not an assessment of this manufacturer.
| Date | Recall No. | Class | Status | Reason |
|---|---|---|---|---|
| Feb 10, 2026 | Z-1574-2026 | — | open, classified | Labeling mix-up resulting in the incorrect lot outer packaging of product. |
| Sep 25, 2025 | Z-0289-2026 | — | open, classified | The device was incorrectly packed in the wrong size labeled outer packaging. |
| Sep 2, 2025 | Z-0034-2026 | — | open, classified | 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. |
| Aug 25, 2025 | Z-0072-2026 | — | open, classified | Devices were distributed with incorrect label without CE and UKCA mark, missing patient leaflet and patient implant card. |
| Apr 11, 2025 | Z-1750-2025 | — | open, classified | During internal product testing, it was observed that some packages to have incomplete seals (sterile barrier). |
| Apr 11, 2025 | Z-1752-2025 | — | open, classified | During internal product testing, it was observed that some packages to have incomplete seals (sterile barrier). |
| Apr 11, 2025 | Z-1751-2025 | — | open, classified | During internal product testing, it was observed that some packages to have incomplete seals (sterile barrier). |
| Apr 17, 2024 | Z-1824-2024 | — | open, classified | The guide tip can become damaged and result in the tip detaching. |
| Jul 13, 2023 | Z-2468-2023 | — | open, classified | Burrs (molding flash) on the cutter may tear the harvested vien |
| Sep 30, 2022 | Z-0228-2023 | — | open, classified | 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. |
| Apr 6, 2021 | Z-1529-2021 | — | terminated | The firm received a complaint regarding particulate found in the packaging foam that could contaminate the sterile field. |
| Mar 23, 2020 | Z-1567-2020 | — | open, classified | There has been an increased trend in reports of catheters failing to deflate during use, which may ultimately lead to tip separation. |
| Jul 24, 2019 | Z-2448-2019 | — | terminated | incorrect device size being listed on the impacted device packaging |
| Oct 1, 2018 | Z-0473-2019 | — | terminated | Pouches from this lot are not sealed compromising the sterility |
| Jun 19, 2018 | Z-3042-2018 | — | terminated | 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. |
| Feb 7, 2017 | Z-1450-2017 | — | terminated | The Contains Latex symbol was not printed onto the box label or the sterile (inner) product pouch |
| Feb 7, 2017 | Z-1442-2017 | — | terminated | The Contains Latex symbol was not printed onto the box label or the sterile (inner) product pouch |
| Feb 7, 2017 | Z-1447-2017 | — | terminated | The Contains Latex symbol was not printed onto the box label or the sterile (inner) product pouch |
| Feb 7, 2017 | Z-1449-2017 | — | terminated | The Contains Latex symbol was not printed onto the box label or the sterile (inner) product pouch |
| Feb 7, 2017 | Z-1446-2017 | — | terminated | The Contains Latex symbol was not printed onto the box label or the sterile (inner) product pouch |
| Feb 7, 2017 | Z-1444-2017 | — | terminated | The Contains Latex symbol was not printed onto the box label or the sterile (inner) product pouch |
| Feb 7, 2017 | Z-1445-2017 | — | terminated | The Contains Latex symbol was not printed onto the box label or the sterile (inner) product pouch |
| Feb 7, 2017 | Z-1448-2017 | — | terminated | The Contains Latex symbol was not printed onto the box label or the sterile (inner) product pouch |
| Feb 7, 2017 | Z-1453-2017 | — | terminated | The Contains Latex symbol was not printed onto the box label or the sterile (inner) product pouch |
| Feb 7, 2017 | Z-1443-2017 | — | terminated | The Contains Latex symbol was not printed onto the box label or the sterile (inner) product pouch |
| Feb 7, 2017 | Z-1451-2017 | — | terminated | The Contains Latex symbol was not printed onto the box label or the sterile (inner) product pouch |
| Feb 7, 2017 | Z-1452-2017 | — | terminated | The Contains Latex symbol was not printed onto the box label or the sterile (inner) product pouch |
| Aug 3, 2016 | Z-2545-2016 | — | terminated | Wire which deploys the loop may be come detached at the handle causing the device to be inoperable |
| Aug 3, 2016 | Z-2543-2016 | — | terminated | Wire which deploys the loop may be come detached at the handle causing the device to be inoperable |
| Aug 3, 2016 | Z-2544-2016 | — | terminated | Wire which deploys the loop may be come detached at the handle causing the device to be inoperable |
| Jun 22, 2016 | Z-2283-2016 | — | terminated | 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 |
| Jun 22, 2016 | Z-2284-2016 | — | terminated | 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. |
| Jun 22, 2016 | Z-2288-2016 | — | terminated | 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. |
| Jun 22, 2016 | Z-2285-2016 | — | terminated | 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. |
| Jun 22, 2016 | Z-2286-2016 | — | terminated | 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. |
| Jun 22, 2016 | Z-2289-2016 | — | terminated | 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. |
| Jun 22, 2016 | Z-2287-2016 | — | terminated | 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. |
| Oct 21, 2015 | Z-0383-2016 | — | terminated | Manufacturing issue that could cause a pinhole in the formed end of the packaging, which may lead to compromised sterility. |
| Oct 21, 2015 | Z-0388-2016 | — | terminated | Manufacturing issue that could cause a pinhole in the formed end of the packaging, which may lead to compromised sterility. |
| Oct 21, 2015 | Z-0390-2016 | — | terminated | Manufacturing issue that could cause a pinhole in the formed end of the packaging, which may lead to compromised sterility. |
| Oct 21, 2015 | Z-0378-2016 | — | terminated | Manufacturing issue that could cause a pinhole in the formed end of the packaging, which may lead to compromised sterility. |
| Oct 21, 2015 | Z-0386-2016 | — | terminated | Manufacturing issue that could cause a pinhole in the formed end of the packaging, which may lead to compromised sterility. |
| Oct 21, 2015 | Z-0385-2016 | — | terminated | Manufacturing issue that could cause a pinhole in the formed end of the packaging, which may lead to compromised sterility. |
| Oct 21, 2015 | Z-0384-2016 | — | terminated | Manufacturing issue that could cause a pinhole in the formed end of the packaging, which may lead to compromised sterility. |
| Oct 21, 2015 | Z-0381-2016 | — | terminated | Manufacturing issue that could cause a pinhole in the formed end of the packaging, which may lead to compromised sterility. |
| Oct 21, 2015 | Z-0379-2016 | — | terminated | Manufacturing issue that could cause a pinhole in the formed end of the packaging, which may lead to compromised sterility. |
| Oct 21, 2015 | Z-0380-2016 | — | terminated | Manufacturing issue that could cause a pinhole in the formed end of the packaging, which may lead to compromised sterility. |
| Oct 21, 2015 | Z-0389-2016 | — | terminated | Manufacturing issue that could cause a pinhole in the formed end of the packaging, which may lead to compromised sterility. |
| Oct 21, 2015 | Z-0387-2016 | — | terminated | Manufacturing issue that could cause a pinhole in the formed end of the packaging, which may lead to compromised sterility. |
| Oct 21, 2015 | Z-0382-2016 | — | terminated | Manufacturing issue that could cause a pinhole in the formed end of the packaging, which may lead to compromised sterility. |
| Feb 24, 2015 | Z-1294-2015 | — | terminated | Mislabeled with an incorrect expiration date |
| Jun 17, 2013 | Z-1758-2013 | — | terminated | Blood blushing/leaking from the surface of the graft after implantation |
| Jun 17, 2013 | Z-1760-2013 | — | terminated | Blood blushing/leaking from the surface of the graft after implantation |
| Jun 17, 2013 | Z-1756-2013 | — | terminated | Blood blushing/leaking from the surface of the graft after implantation |
| Jun 17, 2013 | Z-1755-2013 | — | terminated | Blood blushing/leaking from the surface of the graft after implantation |
| Jun 17, 2013 | Z-1762-2013 | — | terminated | Blood blushing/leaking from the surface of the graft after implantation |
| Jun 17, 2013 | Z-1769-2013 | — | terminated | Blood blushing/leaking from the surface of the graft after implantation |
| Jun 17, 2013 | Z-1770-2013 | — | terminated | Blood blushing/leaking from the surface of the graft after implantation |
| Jun 17, 2013 | Z-1757-2013 | — | terminated | Blood blushing/leaking from the surface of the graft after implantation |
| Jun 17, 2013 | Z-1759-2013 | — | terminated | Blood blushing/leaking from the surface of the graft after implantation |
| Jun 17, 2013 | Z-1764-2013 | — | terminated | Blood blushing/leaking from the surface of the graft after implantation |
| Jun 17, 2013 | Z-1761-2013 | — | terminated | Blood blushing/leaking from the surface of the graft after implantation |
| Jun 17, 2013 | Z-1768-2013 | — | terminated | Blood blushing/leaking from the surface of the graft after implantation |
| Jun 17, 2013 | Z-1754-2013 | — | terminated | Blood blushing/leaking from the surface of the graft after implantation |
| Jun 17, 2013 | Z-1766-2013 | — | terminated | Blood blushing/leaking from the surface of the graft after implantation |
| Jun 17, 2013 | Z-1763-2013 | — | terminated | Blood blushing/leaking from the surface of the graft after implantation |
| Jun 17, 2013 | Z-1767-2013 | — | terminated | Blood blushing/leaking from the surface of the graft after implantation |
| Jun 17, 2013 | Z-1765-2013 | — | terminated | Blood blushing/leaking from the surface of the graft after implantation |
| Mar 18, 2013 | Z-1054-2013 | — | terminated | Devices were not sealed correctly during the manufacturing process, and the sterility of these products have been compromised. |
| Mar 18, 2013 | Z-1055-2013 | — | terminated | Devices were not sealed correctly during the manufacturing process, and the sterility of these products have been compromised. |
| Oct 4, 2011 | Z-0070-2012 | — | terminated | Extended Expiration on the outer box label 2016-05, the correct expiration date is on the tray label: 2014-05 |
| Oct 22, 2010 | Z-0436-2011 | — | terminated | Box label (Top Part). Lot and Expiration Date information were switched. |
| Oct 22, 2010 | Z-0434-2011 | — | terminated | Box label (Top Part). Lot and Expiration Date information were switched. |
| Oct 22, 2010 | Z-0433-2011 | — | terminated | Box label (Top Part). Lot and Expiration Date information were switched. |
| Oct 22, 2010 | Z-0435-2011 | — | terminated | Box label (Top Part). Lot and Expiration Date information were switched. |
| Sep 22, 2010 | Z-0165-2011 | — | terminated | Mislabeled size on external packaging: The contents section listed on the Tyvek lid labels of the Medium and Large sizes incorrectly identified the size of the clip as XL, while the device inside was either a Medium or Large size. |
| Sep 22, 2010 | Z-0164-2011 | — | terminated | Mislabeled size on external packaging: The contents section listed on the Tyvek lid labels of the Medium and Large sizes incorrectly identified the size of the clip as XL, while the device inside was either a Medium or Large size. |
| Jul 18, 2007 | Z-0008-2008 | — | terminated | Sterility of device may be compromised due to breach in sterile barrier. |
| May 17, 2005 | Z-0219-06 | — | terminated | LeMaitre Vascular is recalling certain lots of its Pruitt Aortic Occlusion Catheters due to a packaging defect which could compromise product sterility. |
| Feb 7, 2005 | Z-0557-05 | — | terminated | Product sterility maybe compromised due to defective packaging |
| Feb 7, 2005 | Z-0561-05 | — | terminated | Product sterility maybe compromised due to defective packaging |
| Feb 7, 2005 | Z-0559-05 | — | terminated | Product sterility maybe compromised due to defective packaging |
| Feb 7, 2005 | Z-0558-05 | — | terminated | Product sterility maybe compromised due to defective packaging |
| Feb 7, 2005 | Z-0560-05 | — | terminated | Product sterility maybe compromised due to defective packaging |