Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
THERMOCOOL SMARTTOUCH SF Bi-Directional Navigation Catheter Recalled by Johnson & Johnson Surgical Vision, Inc. Due to Manufacturing error resulted in potential contamination of Bi-Directional...
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 Johnson & Johnson Surgical Vision, Inc. directly.
Affected Products
THERMOCOOL SMARTTOUCH SF Bi-Directional Navigation Catheter, REF: D-1348-05-S. Used for catheter-based cardiac electrophysiological mapping (stimulation and recording) and, in conjunction with an RF generator, for cardiac ablation.
Quantity: 91
Why Was This Recalled?
Manufacturing error resulted in potential contamination of Bi-Directional navigation catheter irrigation path with cellulose fibers that can cause 1) Failure of initial flushing inspection, 2) Insufficient irrigation causing catheter tip temperature increase, limiting the ability to deliver ablation, or 3) particles flushed through the catheter irrigation may have thrombogenic/toxic effect.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Johnson & Johnson Surgical Vision, Inc.
Johnson & Johnson Surgical Vision, Inc. has 10 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report