Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
The LeMaitre Aortic Occlusion Catheter is a single lumen catheter Recalled by LeMaitre Vascular, Inc. Due to incorrect device size being listed on the impacted...
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
The LeMaitre Aortic Occlusion Catheter is a single lumen catheter with a latex balloon, it is offered in two balloon sizes: 28 mm or 45mm. The single lumen acts as the inflation lumen for the balloon and is indicated by the white stopcock. Other features include a balloon wall thickness designed to reduce the possibility of puncture by calcium deposits, and a stop-cock to maintain balloon inflation level throughout the procedure.
Quantity: 62 units
Why Was This Recalled?
incorrect device size being listed on the impacted device packaging
Where Was This Sold?
GERMANY FRANCE SLOVENIA SPAIN SWEDEN UK
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