LeMaitre Vascular Recalls 1.5 mm HYDRO Valvulotome Due to Wire Detachment
LeMaitre Vascular is recalling 380 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 functional defect (device inoperability) rather than a direct physical injury or contamination, and no injuries or illnesses are reported in the source text.
Plain-English summary
LeMaitre Vascular, Inc. is recalling 380 units of the 1.5 mm HYDRO LeMaitre Valvulotome without LeMills, 98 cm. Sterile (REF# 1009-00J). The device is intended for the treatment of vascular disorders, specifically for excising or disrupting venous valves.
The recall was initiated because the wire that deploys the loop may become detached at the handle, causing the device to be inoperable. The affected lots are ELVH1078V and ELVH1079VA, both with an expiration date of October 2020.
The products 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. Healthcare providers and facilities should stop using the affected devices and contact LeMaitre Vascular for instructions on return or replacement.
The recalled product
- Product
- 1.5 mm HYDRO LeMaitre Valvulotome without LeMills, 98 cm. Sterile REF# 1009-00J 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 Device
- Hazard
- Affected units
- 380
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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