Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
20-Pole LASSO Nav Catheter Eco Recalled by Biosense Webster, Inc. Due to Biosense Webster is recalling the 20-Pole LASSO NAV...
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 Biosense Webster, Inc. directly.
Affected Products
20-Pole LASSO Nav Catheter Eco, Catalog # D-1349-02S. Designed to facilitate electrophysiological mapping of the atria of the heart.
Quantity: 10 units
Why Was This Recalled?
Biosense Webster is recalling the 20-Pole LASSO NAV Catheter Eco because it has been incorrectly calibrated causing them to be recognized and displayed as a 10-Pole LASSO NAV Catheter Eco by the CARTO 3 System.
Where Was This Sold?
This product was distributed to 3 states: FL, MN, UT
About Biosense Webster, Inc.
Biosense Webster, Inc. has 31 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report