LeMaitre Vascular Recalls 1.5 mm HYDRO LeMaitre Valvulotome Devices
LeMaitre Vascular is recalling 50 units of the 1.5 mm HYDRO LeMaitre Valvulotome because the wire may detach, rendering the device inoperable.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II. The hazard is a mechanical failure resulting in an inoperable device, which is a significant functional defect but does not involve reported injuries, fatalities, or direct physical harm to the patient.
Plain-English summary
LeMaitre Vascular, Inc. is recalling 50 units of the 1.5 mm HYDRO LeMaitre Valvulotome, 40 cm. Sterile (REF # 1010-00). The device is intended for the treatment of vascular disorders, specifically for excising or disrupting venous valves.
The recall is due to a defect where the wire that deploys the loop may become detached at the handle, causing the device to be inoperable. The affected units are from lot numbers ELVH1089V and ELVH1091V, both with an expiration date of 2021-03.
The affected devices were distributed worldwide, including in the United States, Australia, Belgium, Brazil, Canada, the Czech Republic, Denmark, Finland, France, Germany, Italy, Japan, the Netherlands, Russia, Spain, Sweden, Switzerland, and the United Kingdom. Users should stop using the affected devices and contact LeMaitre Vascular for instructions.
The recalled product
- Product
- 1.5 mm HYDRO LeMaitre Valvulotome, 40 cm. Sterile REF # 1010-00 Product Usage: The HYDRO LeMaitre Valvulotome is intended for the treatment of vascular disorders and more particularly for excising or disrupting venous valves
- Manufacturer
- LeMaitre Vascular, Inc.
- Category
- Medical Device — Vascular
- Hazard
- Affected units
- 50
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 3 recalled by LeMaitre Vascular, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 3 products in this recall →Related recalls
Same manufacturer · LeMaitre Vascular, Inc.
See all →- ModerateLeMaitre TufTex Over-the-Wire Embolectomy Catheter Recalled for Balloon Failure
FDA (Devices) · 2026-10-14
- ModerateArtegraft vascular graft recalled over incorrect lot outer packaging labeling
FDA (Devices) · 2026-03-25
- ModerateCollagen vascular graft recalled after being packed in wrong size packaging
FDA (Devices) · 2025-10-29
- ModerateCollagen vascular grafts recalled over incorrect labels missing CE and UKCA marks
FDA (Devices) · 2025-10-15
- ModerateCollagen vascular grafts recalled over unapproved bovine raw material supplier
FDA (Devices) · 2025-10-08
Same hazard · mechanical failure
See all →- SevereCanon Medical Alphenix INFX-8000C/B5 Recalled for Tabletop Shift Risk
FDA (Devices) · 2026-10-14
- HighMirion Captus 4000e Thyroid Uptake System Recalled for Spring Arm Failure
FDA (Devices) · 2026-09-23
- HighIMRIS ORT200 Operating Room Table Recalled for Mechanical Failure Risk
FDA (Devices) · 2026-09-02
- HighIMRIS ORT300 Operating Room Table Recalled for Mechanical Failure Risk
FDA (Devices) · 2026-09-02
- HighForest River Transit Buses Recalled for Wheelchair Lift Control Failure
NHTSA · 2026-09-01
Similar recalls
- ModerateLeMaitre Over-the-Wire Embolectomy Catheter Recalled for Packaging Defect
FDA (Devices) · 2015-12-16
- HighLeMaitre Over-the-Wire Embolectomy Catheter Recall for Packaging Defect
FDA (Devices) · 2015-12-16
- ModerateLeMaitre Embolectomy Catheter Recalled for Packaging Sterility Risk
FDA (Devices) · 2015-12-16
- HighLeMaitre Over-the-Wire Embolectomy Catheter Recalled for Packaging Sterility Risk
FDA (Devices) · 2015-12-16
- HighChevalier Valvulotome Surgical Instrument Recalled Due to Burr Defect
FDA (Devices) · 2023-09-06
- ModerateLeMaitre Aortic Occlusion Catheter Recalled for Incorrect Size Labeling
FDA (Devices) · 2019-09-11