Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Biosense Webster Carto Vizigo Bi-Directional Guiding Sheath Recalled by Biosense Webster, Inc. Due to Incorrect labeling; specifically, the product name, lot number...
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
Biosense Webster Carto Vizigo Bi-Directional Guiding Sheath, 8.5F(Small), REF D-1385-01-S, RX CE 2797, Sterile
Quantity: 277
Why Was This Recalled?
Incorrect labeling; specifically, the product name, lot number and product code on the carton label for Bi-Directional Guiding Sheaths does not match the inner label pouch
Where Was This Sold?
This product was distributed nationwide across all 50 states.
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