Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
ThermoCool SmartTouch Navigation Catheters Recalled by Biosense Webster, Inc. Due to The recall was initiated because Biosense Webster is...
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
ThermoCool SmartTouch Navigation Catheters, Catalog No. D132701, D132702, D132703, D132704, D132705, D133601, D133602, D133603.
Quantity: 173,329 units total (21,812 units in US)
Why Was This Recalled?
The recall was initiated because Biosense Webster is providing additional labeling for the safe and effective use of the ThermoCool SmartTouch Catheter.
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