Facility

LEMAITRE VASCULAR, INC.

16 recall(s) on record — most severe on record: Class I.

Key facts

16recalls · worst Class I

4inspections · worst VAI

—warning letters in our data

Recalls are listed for the parent company: openFDA recall records do not name a facility. How we attribute records

FDA Establishment Identifier (FEI)	1220948
Establishment type	Manufacture Medical Device
Location	63 SECOND AVENUE BURLINGTON, MA, US 01803
Registration status	Active · expires 2026
Parent company	LEMAITRE VASCULAR, INC. (owner-operator 1220948)
Brand names	Albograft Vascular Grafts

Activity by year

Recalls (16)
Inspections (4)

Devices registered here (1)

Graft, Vascular, Synthetic/Biologic Composite
Product code MAL (opens in a new tab) · Class II · Cardiovascular · 21 CFR 870.3450

Recalls & enforcement

20251 record

Class IIOngoing2025-04-11
During internal product testing, it was observed that some packages to have incomplete seals (sterile barrier).

20241 record

Class IIOngoing2024-04-17
The guide tip can become damaged and result in the tip detaching.

20231 record

Class IIOngoing2023-07-13
Burrs (molding flash) on the cutter may tear the harvested vien

20221 record

Class IIOngoing2022-09-30
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 be…

20211 record

Class IITerminated2021-04-06
The firm received a complaint regarding particulate found in the packaging foam that could contaminate the sterile field.

20201 record

Class IOngoing2020-03-23
There has been an increased trend in reports of catheters failing to deflate during use, which may ultimately lead to tip separation.

20191 record

Class IITerminated2019-07-24
incorrect device size being listed on the impacted device packaging

20182 records

Class IITerminated2018-10-01
Pouches from this lot are not sealed compromising the sterility
Class IITerminated2018-06-19
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…

20171 record

Class IITerminated2017-02-07
The Contains Latex symbol was not printed onto the box label or the sterile (inner) product pouch

20162 records

Class IITerminated2016-08-03
Wire which deploys the loop may be come detached at the handle causing the device to be inoperable
Class IITerminated2016-06-22
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.

20152 records

Class IITerminated2015-10-21
Manufacturing issue that could cause a pinhole in the formed end of the packaging, which may lead to compromised sterility.
Class IIITerminated2015-02-24
Mislabeled with an incorrect expiration date

20132 records

Class ITerminated2013-06-17
Blood blushing/leaking from the surface of the graft after implantation
Class IITerminated2013-03-18
Devices were not sealed correctly during the manufacturing process, and the sterility of these products have been compromised.

FDA inspections (4)

VAI2023-05-16
Voluntary Action Indicated · Compliance: Devices · citations posted
VAI2022-06-15
Voluntary Action Indicated · Compliance: Devices · citations posted
NAI2020-08-27
No Action Indicated · Compliance: Devices
NAI2017-08-01
No Action Indicated · Compliance: Devices

Source: U.S. FDA Inspections Dashboard (opens in a new tab) (device inspection classifications, 2016–present). Data as of 2026-10-06. The dashboard profile can take several seconds to load.

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this facility record at FDA → (opens in a new tab)

Cite this record

RegWarden. “LEMAITRE VASCULAR, INC. (FEI 1220948) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/1220948-lemaitre-vascular-inc/

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