Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
LeMaitre Stent Guide: 1102-00 (100 strips) Recalled by LeMaitre Vascular, Inc. Due to Devices were not sealed correctly during the manufacturing...
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
LeMaitre Stent Guide: 1102-00 (100 strips); 1102-50 (50 strips); 1102-20 (20 strips). Intended to be placed on the skin to assist during imaging procedures.
Quantity: 6970
Why Was This Recalled?
Devices were not sealed correctly during the manufacturing process, and the sterility of these products have been compromised.
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