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.
What this means for you
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.
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