Chrysalis Intelligence · Sponsors · Lemaitre Vascular

Lemaitre Vascular

Burlington, MA, US · 2 510(k) clearances · 10 PMAs · 12 recalls (1 Class I)

← Library Overview New Filings 510(k) Explorer Recalls Explorer All Sponsors All Product Codes Orphan Products Signals
Total clearances
2
2020-02-13 → 2022-03-31
Last 12 months
0
Product codes
2
Most recent
2022-03-31
Name variants in FDA filings: Lemaitre Vascular / LeMaitre Vascular, Inc.
Trend

Clearance cadence by quarter

Portfolio

Product codes worked

Code Device name Class Specialty Clearances Most recent
DWQ — — — 1 2022-03-31
PSQ Intracardiac Patch Or Pledget, Biologically Derived Class II Cardiovascular 1 2020-02-13
Class III

PMA approvals (10)

Total PMA records
10
Originals + supplements
Distinct product codes
1
First decision
2020-05-06
Most recent
2025-06-11
DatePMA #Trade nameTypeCodeDevice nameSpecialty
2025-06-11 N16837-S036 Artegraft Collagen Vascular Graft 30-Day Notice LXA Tissue Graft Of 6mm And Greater Unknown
2024-12-18 N16837-S035 Artegraft Collagen Vascular Graft 30-Day Notice LXA Tissue Graft Of 6mm And Greater Unknown
2024-10-17 N16837-S034 Artegraft Collagen Vascular Graft 30-Day Notice LXA Tissue Graft Of 6mm And Greater Unknown
2024-05-02 N16837-S033 Artegraft Collagen Vascular Graft 30-Day Notice LXA Tissue Graft Of 6mm And Greater Unknown
2023-09-19 N16837-S032 Artegraft Collagen Vascular Graft 30-Day Notice LXA Tissue Graft Of 6mm And Greater Unknown
2023-06-29 N16837-S031 Artegraft Collagen Vascular Graft 30-Day Notice LXA Tissue Graft Of 6mm And Greater Unknown
2023-04-25 N16837-S030 Artegraft Collagen Vascular Graft 30-Day Notice LXA Tissue Graft Of 6mm And Greater Unknown
2023-01-25 N16837-S029 Artegraft Collagen Vascular Graft 30-Day Notice LXA Tissue Graft Of 6mm And Greater Unknown
2022-10-14 N16837-S028 Artegraft Collagen Vascular Graft 30-Day Notice LXA Tissue Graft Of 6mm And Greater Unknown
2020-05-06 N16837-S026 Artegraft Collagen Vascular Graft 30-Day Notice LXA Tissue Graft Of 6mm And Greater Unknown
Safety

Recalls (12)

Class I (serious)
1
Risk of injury / death
Total recalls
12
Currently ongoing
11
Most recent
2026-02-10
DateSeverityStatusRecall # ProductCodeReason
2026-02-10 Class II Ongoing Z-1574-2026 Artegraft Vascular Graft; REF#: AG740; — Labeling mix-up resulting in the incorrect lot outer packaging of product.
2025-09-25 Class II Ongoing Z-0289-2026 Artegraft¿ Collagen Vascular Graft; REF: AG1015; — The device was incorrectly packed in the wrong size labeled outer packaging.
2025-09-02 Class II Ongoing Z-0034-2026 Artegraft Collagen Vascular Grafts Model Numbers: (1) AG 616, (2) AG 630, (3) AG 636, (4) AG 640, (5) AG 645, (6) AG 71… — 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 an…
2025-08-25 Class II Ongoing Z-0072-2026 Artegraft Collagen Vascular Graft. Model/Catalog/Part Numbers: AG630M, AG636M, AG730M, AG740M, AG845M. The Artegr… — Devices were distributed with incorrect label without CE and UKCA mark, missing patient leaflet and patient implant card.
2025-04-11 Class II Ongoing Z-1752-2025 Pruitt Irrigation Occlusion Catheter. Catalog Numbers: 2102-09, E2102-09. — During internal product testing, it was observed that some packages to have incomplete seals (sterile barrier).
2025-04-11 Class II Ongoing Z-1751-2025 Pruitt Occlusion Catheter. Catalog Numbers: 2103-36, 2103-46, 2103-56, E2103-36, E2103-46, E2103-56 — During internal product testing, it was observed that some packages to have incomplete seals (sterile barrier).
2025-04-11 Class II Ongoing Z-1750-2025 TufTex Over-the-Wire Embolectomy Catheter. All Catalog numbers: 1651-34, 1651-38, 1651-44, 1651-48, 1651-58, 1651-64, 1… — During internal product testing, it was observed that some packages to have incomplete seals (sterile barrier).
2024-04-17 Class II Ongoing Z-1824-2024 Syntel Silicone Thrombectomy Catheter, Sterile, Rx Only. Used in vascular grafts and peripheral venous thrombectomies. — The guide tip can become damaged and result in the tip detaching.
2023-07-13 Class II Ongoing Z-2468-2023 The Chevalier Valvulotome is a device used to disrupt the valves of veins which are to be used as grafts in the in situ … — Burrs (molding flash) on the cutter may tear the harvested vien
2022-09-30 Class II Ongoing Z-0228-2023 TufTex Embolectomy Catheter, Model No. This catheter has a latex balloon and a single lumen extrusion. It is inserte… — Three lots tied by two trainees were released without performing the required pull test. If tied with inadequate strength, the proximal ligature could slip towa…
2021-04-06 Class II Terminated Z-1529-2021 LeverEdge Contrast Injector: 35 cc syringe with ISO 594 female luer lock - Product Usage: intended to be used to perfuse… — The firm received a complaint regarding particulate found in the packaging foam that could contaminate the sterile field.
2020-03-23 Class I Ongoing Z-1567-2020 LeMaitre 5F Plus Over the Wire Embolectomy Catheter, Model Nos. 1651-84, e1651-84, 1651-88, e1651-88. The LeMaitre Ov… — There has been an increased trend in reports of catheters failing to deflate during use, which may ultimately lead to tip separation.
Filings

All 510(k) clearances (2)

Date K-number Device Code Class Specialty
2022-03-31 K212894 PhasTIPP DWQ — —
2020-02-13 K190882 XenoSure Biologic Patch PSQ Class II Cardiovascular
Data source: openFDA · Generated 2026-08-26 09:36 · Last ingest 2026-08-26T13:35:45.365163 · Pipeline: Chrysalis Intelligence