LeMaitre Vascular recalls

LeMaitre Vascular has 71 recalls on record with the FDA and USDA, the earliest in 2013 and the latest reported on 14 Oct 2026. 12 are still ongoing. 3 were reported in the last 12 months. The most frequent reason is sterility.

Total recalls71since 2013

Last 12 months3reported

Class I1825% of total

Ongoing12latest 14 Oct 2026

Recalls per month, last 24 months

click a bar for that month

0Nov '24 0 0 0Feb 0 0 3May 0 0 0Aug 0 3 0Nov 0 0 0Feb 1 0 0May 0 0 0Aug 0 1

Severity split

Class I 18 25%Class II 52 73%Class III 1 1%

Why lemaitre vascular is recalled

Product types

By year

202623%
202568%
202411%
202311%
202211%
202111%
202011%
201911%
201823%
20171217%

Ongoing lemaitre vascular recalls

12 active

Reported	Class	Recall	Company	Reason	Where
14 Oct 2026Device	CLASS II	TufTex¿ Over-the-Wire Embolectomy Catheter recalled	LeMaitre Vascular	Other	Nationwide
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	NJ
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

All lemaitre vascular recalls, newest first

71 total

Reported	Class	Recall	Company	Reason	Where
14 Oct 2026Device	CLASS II	TufTex¿ Over-the-Wire Embolectomy Catheter recalled	LeMaitre Vascular	Other	Nationwide
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	NJ
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	Other	Nationwide
6 Sep 2023Device	CLASS II	The Chevalier Valvulotome is a device used to disrupt recalled	LeMaitre Vascular	Foreign Material	MA
23 Nov 2022Device	CLASS II	TufTex Embolectomy Catheter recalled by LeMaitre Vascular	LeMaitre Vascular	Device Malfunction	MA
12 May 2021Device	CLASS II	LeverEdge Contrast Injector: 35 cc syringe recalled by LeMaitre Vascular	LeMaitre Vascular	Particulate Matter	Nationwide
8 Apr 2020Device	CLASS I	LeMaitre 5F Plus Over the Wire Embolectomy Catheter recalled	LeMaitre Vascular	Other	Nationwide
11 Sep 2019Device	CLASS II	The LeMaitre Aortic Occlusion Catheter is a single lumen recalled	LeMaitre Vascular	Packaging Defects	MA
28 Nov 2018Device	CLASS II	Pruitt F3¿-S Polyurethane Outlying Carotid Shunt, Sterile recalled	LeMaitre Vascular	Sterility	FL
19 Sep 2018Device	CLASS II	AnastoClip GC Closure System recalled by LeMaitre Vascular	LeMaitre Vascular	Other	5 states
22 Mar 2017Device	CLASS II	Reddick Cholangiogram Stiffer Catheter (eIFU) recalled	LeMaitre Vascular	Sterility	Nationwide
22 Mar 2017Device	CLASS II	Reddick Cholangiogram Stiffer Catheter with introducer (paper IFU) recalled	LeMaitre Vascular	Sterility	Nationwide
22 Mar 2017Device	CLASS II	Reddick Cholangiogram Catheter (eIFU) recalled by LeMaitre Vascular	LeMaitre Vascular	Sterility	Nationwide
22 Mar 2017Device	CLASS II	Scoop Tip Cholangiogram Catheter with Introducer (eIFU) recalled	LeMaitre Vascular	Sterility	Nationwide
22 Mar 2017Device	CLASS II	Reddick Scoop Tip Cholangiogram Stiffer Catheter (paper IFU) recalled	LeMaitre Vascular	Sterility	Nationwide
22 Mar 2017Device	CLASS II	Reddick Scoop Tip Cholangiogram Catheter with Introducer (eIFU) recalled	LeMaitre Vascular	Sterility	Nationwide
22 Mar 2017Device	CLASS II	Scoop Tip Cholangiogram Catheter with Introducer (eIFU) recalled	LeMaitre Vascular	Sterility	Nationwide
22 Mar 2017Device	CLASS II	Reddick Scoop Tip Cholangiogram Catheter (eIFU) recalled	LeMaitre Vascular	Sterility	Nationwide
22 Mar 2017Device	CLASS II	Reddick Cholangiogram Stiffer Catheter with introducer (eIFU) recalled	LeMaitre Vascular	Sterility	Nationwide
22 Mar 2017Device	CLASS II	Reddick Cholangiogram Catheter with introducer(eIFU) recalled	LeMaitre Vascular	Sterility	Nationwide
22 Mar 2017Device	CLASS II	Scoop Tip Cholangiogram Catheter with Introducer (paper IFU) recalled	LeMaitre Vascular	Sterility	Nationwide
22 Mar 2017Device	CLASS II	Reddick Scoop Tip Cholangiogram Stiffer Catheter recalled	LeMaitre Vascular	Sterility	Nationwide
24 Aug 2016Device	CLASS II	Hydro LeMaitre Valvulotome Sterile recalled by LeMaitre Vascular	LeMaitre Vascular	Other	Nationwide
24 Aug 2016Device	CLASS II	Hydro LeMaitre Valvulotome, Sterile recalled by LeMaitre Vascular	LeMaitre Vascular	Other	Nationwide

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.