Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Carto 3 EP Navigation System. Electro physiology system which views Recalled by Biosense Webster, Inc. Due to Image disappeared from the cardiac ultrasound system when...
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
Carto 3 EP Navigation System. Electro physiology system which views of the electrical activity of the heart through real-time data on 3-D, color-coded cardiac maps.
Quantity: 1035 (U.S.)
Why Was This Recalled?
Image disappeared from the cardiac ultrasound system when the CARTO 3 EP Navigation System needed restarting while the patient was experiencing pericardial effusion. Affects the CARTOSOUND Module of the CARTO 3 EP Navigation System when used with the SOUNDSTAR eco 8F and 10F Diagnostic Ultrasound Catheters. New precautions added.
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