LeMaitre Vascular recalls

LeMaitre Vascular has 70 recalls on record with the FDA and USDA, the earliest in 2013 and the latest reported on 25 Mar 2026. 11 are still ongoing. 4 were reported in the last 12 months. The most frequent reason is sterility.

Total recalls70since 2013

Last 12 months4reported

Class I1826% of total

Ongoing11latest 25 Mar 2026

Recalls per month, last 24 months

click a bar for that month

0Oct '24 0 0 0Jan '25 0 0 0Apr 3 0 0Jul 0 0 3Oct 0 0 0Jan '26 0 1 0Apr 0 0 0Jul 0 0

Severity split

Class I 18 26%Class II 51 73%Class III 1 1%

Why lemaitre vascular is recalled

Product types

By year

202611%
202569%
202411%
202311%
202211%
202111%
202011%
201911%
201823%
20171217%

Ongoing lemaitre vascular recalls

11 active

Reported	Class	Recall	Company	Reason	Where
25 Mar 2026Device	CLASS II	Artegraft Vascular Graft recalled by LeMaitre Vascular	LeMaitre Vascular	Packaging Defects	Nationwide
29 Oct 2025Device	CLASS II	Artegraft¿ Collagen Vascular Graft recalled by LeMaitre Vascular	LeMaitre Vascular	Packaging Defects	AR
15 Oct 2025Device	CLASS II	Artegraft Collagen Vascular Graft recalled by LeMaitre Vascular	LeMaitre Vascular	Labeling Errors	Nationwide
8 Oct 2025Device	CLASS II	Artegraft Collagen Vascular Grafts recalled by LeMaitre Vascular	LeMaitre Vascular	Other	Nationwide
21 May 2025Device	CLASS II	Pruitt Irrigation Occlusion Catheter recalled by LeMaitre Vascular	LeMaitre Vascular	Sterility	Nationwide
21 May 2025Device	CLASS II	TufTex Over-the-Wire Embolectomy Catheter recalled by LeMaitre Vascular	LeMaitre Vascular	Sterility	Nationwide

All lemaitre vascular recalls, newest first

70 total

Reported	Class	Recall	Company	Reason	Where
25 Mar 2026Device	CLASS II	Artegraft Vascular Graft recalled by LeMaitre Vascular	LeMaitre Vascular	Packaging Defects	Nationwide
29 Oct 2025Device	CLASS II	Artegraft¿ Collagen Vascular Graft recalled by LeMaitre Vascular	LeMaitre Vascular	Packaging Defects	AR
15 Oct 2025Device	CLASS II	Artegraft Collagen Vascular Graft recalled by LeMaitre Vascular	LeMaitre Vascular	Labeling Errors	Nationwide
8 Oct 2025Device	CLASS II	Artegraft Collagen Vascular Grafts recalled by LeMaitre Vascular	LeMaitre Vascular	Other	Nationwide
21 May 2025Device	CLASS II	Pruitt Irrigation Occlusion Catheter recalled by LeMaitre Vascular	LeMaitre Vascular	Sterility	Nationwide
21 May 2025Device	CLASS II	TufTex Over-the-Wire Embolectomy Catheter recalled by LeMaitre Vascular	LeMaitre Vascular	Sterility	Nationwide
21 May 2025Device	CLASS II	Pruitt Occlusion Catheter recalled by LeMaitre Vascular	LeMaitre Vascular	Sterility	Nationwide
22 May 2024Device	CLASS II	Syntel Silicone Thrombectomy Catheter, Sterile recalled	LeMaitre Vascular	Sterility	Nationwide
6 Sep 2023Device	CLASS II	The Chevalier Valvulotome is a device used to disrupt recalled	LeMaitre Vascular	Foreign Material	Nationwide
23 Nov 2022Device	CLASS II	TufTex Embolectomy Catheter recalled by LeMaitre Vascular	LeMaitre Vascular	Device Malfunction	MA

About this list

Records come from FDA enforcement reports and USDA FSIS notices, grouped by normalised name. A company operating under several names may appear more than once.