Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
1.5 mm HYDRO LeMaitre Valvulotome Recalled by LeMaitre Vascular, Inc. Due to Wire which deploys the loop may be come...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact LeMaitre Vascular, Inc. directly.
Affected Products
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
Quantity: 50 units
Why Was This Recalled?
Wire which deploys the loop may be come detached at the handle causing the device to be inoperable
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About LeMaitre Vascular, Inc.
LeMaitre Vascular, Inc. has 69 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report