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LeMaitre 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

Information

Country: United States
Address: 63, Second Avenue, Burlington, Massachusetts, United States
Website: www.lemaitre.com
LinkedIn: linkedin.com/company/lemaitre-vascular
Facebook: —
Email: [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 9 of 12

Device	Model / Reference	Registries	Class	Status
AlboGraft Polyester Vascular Graft	ATC3016	FDA UDI	Class II	Unknown
AlboGraft Polyester Vascular Graft	AMC3010	FDA UDI	Class II	Unknown
ProCol Biologic Vascular Graft	HJL016-30-N	FDA UDI	Class III	Active
LifeSpan ePTFE Vascular Graft	RS47050	FDA UDI	Class II	Unknown
Syntel Silicone OTW Embolectomy Catheter	A4E08	FDA UDI	Class II	Active
Grice Laparoscopic Suture Needle	e2504-02	FDA UDI	Class II	Active
Trivex System	7210375	FDA UDI	Class II	Active
VascuTape Radiopaque Tape	1108-20	FDA UDI	Class II	Active
LifeSpan ePTFE Vascular Graft	T08010	FDA UDI	Class II	Unknown
AlboGraft Polyester Vascular Graft	ATC9034	FDA UDI	Class II	Unknown
Eze-Sit Valvulotome	94cm	EUDAMEDFDA UDI	Class II	Active
LeMaitre Embolectomy Catheter	e1651-88	FDA UDI	Class II	Active
LeMaitre Embolectomy Catheter	e1801-74	FDA UDI	Class II	Active
LeMaitre Embolectomy Catheter	e1601-48	FDA UDI	Class II	Active
AlboGraft Polyester Vascular Graft	ATC3012	FDA UDI	Class II	Unknown
Pruitt Occlusion Catheter	2103-46	FDA UDI	Class II	Active
AlboGraft Polyester Vascular Graft	AMC2211	FDA UDI	Class II	Unknown
Expandable LeMaitre Valvulotome	e1000-90	FDA UDI	Class II	Unknown
LifeSpan ePTFE Vascular Graft	GR74070	FDA UDI	Class II	Unknown
Pruitt Occlusion Catheter	e2103-36	FDA UDI	Class II	Active
Polyurethane Dual Lumen Occlusion Catheter	5F-2L-80	FDA UDI	Class II	Active
AlboGraft Polyester Vascular Graft	AMC1407	FDA UDI	Class II	Unknown
LeMaitre Embolectomy Catheter	1601-24	FDA UDI	Class II	Active
Pruitt F3 Carotid Shunt	e2012-11	FDA UDI	Class II	Active
AlboGraft Polyester Vascular Graft	AMC1810	FDA UDI	Class II	Unknown
LifeSpan ePTFE Vascular Graft	QT47050	FDA UDI	Class II	Unknown
AlboGraft Polyester Vascular Graft	AMC8010	FDA UDI	Class II	Unknown
AlboGraft Polyester Vascular Graft	ATC1514	FDA UDI	Class II	Unknown
Syntel Silicone OTW Embolectomy Catheter	A4E01	FDA UDI	Class II	Active
LeMaitre Embolectomy Catheter	e1651-64	FDA UDI	Class II	Active
LifeSpan ePTFE Vascular Graft	QT47045CS	FDA UDI	Class II	Unknown
LeMaitre Embolectomy Catheter	1801-38	FDA UDI	Class II	Active
AlboGraft Polyester Vascular Graft	ATC1508	FDA UDI	Class II	Unknown
Syntel Silicone OTW Embolectomy Catheter	A4E02	FDA UDI	Class II	Active
Syntel Silicone OTW Embolectomy Catheter	A4E06	FDA UDI	Class II	Active
AlboGraft Polyester Vascular Graft	ATC3032	FDA UDI	Class II	Unknown
MultiTASC Dissection/Transection Device	4500-05	FDA UDI	Class II	Active
AlboGraft Polyester Vascular Graft	AMC1518	FDA UDI	Class II	Unknown
Expandable LeMaitre Valvulotome	e1096-00	FDA UDI	Class II	Active
MultiTASC Dissection/Transection Device	4500-04	FDA UDI	Class II	Active
LeMaitre Embolectomy Catheter	e1601-24	FDA UDI	Class II	Active
LifeSpan ePTFE Vascular Graft	R06015CS	FDA UDI	Class II	Unknown
Reddick Cholangiogram Catheter	e2400-53	FDA UDI	Class I	Active
AlboGraft Polyester Vascular Graft	ATC6024	FDA UDI	Class II	Unknown
LifeSpan ePTFE Vascular Graft	R08080C80	FDA UDI	Class II	Unknown
Anastoclip AC Closure System	4000-05	FDA UDI	Class II	Active
LeMaitre Embolectomy Catheter	1651-84	FDA UDI	Class II	Active
Flexcel Carotid Shunt	2020-15	FDA UDI	Class II	Active
AlboGraft Polyester Vascular Graft	ATC2412	FDA UDI	Class II	Unknown
Expandable LeMaitre Valvulotome	1000-90	FDA UDI	Class II	Unknown

Related Companies

Authorised Representatives

LeMaitre Vascular GmbH DE

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.

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