LeMaitre Vascular Recalls 1.5 mm HYDRO LeMaitre Valvulotome Devices
LeMaitre Vascular is recalling 1,992 units of the 1.5 mm HYDRO LeMaitre Valvulotome because the wire may detach at the handle, 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, with no reported injuries or illnesses in the source text, fitting the criteria for a moderate severity recall.
Plain-English summary
LeMaitre Vascular, Inc. is recalling 1,992 units of the 1.5 mm HYDRO LeMaitre Valvulotome, 98 cm, Sterile (REF # 1009-00). 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 ELVH1072V, ELVH1082V, ELVH1083V, ELVH1084V, ELVH1085V, ELVH1086V, ELVH1087V, and ELVH1088V, with expiration dates ranging from July 2020 to March 2021.
The 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. Healthcare providers and patients should stop using the affected devices and contact LeMaitre Vascular for further instructions.
The recalled product
- Product
- 1.5 mm HYDRO LeMaitre Valvulotome, 98 cm, Sterile REF # 1009-00 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
- 1,992
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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