Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
TufTex Embolectomy Catheter Recalled by LeMaitre Vascular, Inc. Due to Three lots tied by two trainees were released...
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
TufTex Embolectomy Catheter, Model No. This catheter has a latex balloon and a single lumen extrusion. It is inserted using a guidewire or introducer. The devices affected by this recall are 3F and 4F..
Quantity: 72 (OUS only)
Why Was This Recalled?
Three lots tied by two trainees were released without performing the required pull test. If tied with inadequate strength, the proximal ligature could slip toward the tip of the catheter and block the inflation hole, leading to the risk of the tip breaking off, and potentially becoming lost in the blood vessel.
Where Was This Sold?
No US distribution. Foreign distribution to United Kingdom, Germany, France, Sweden, Austria, and Italy.
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