Serious health hazard — there is a reasonable probability that use of or exposure to this product will cause serious adverse health consequences or death.
VARIPULSE Bi-Directional Ablation Catheter REF D141201. The Field Catheter is Recalled by Biosense Webster, Inc. Due to Due to an observed trend of neurovascular events
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
VARIPULSE Bi-Directional Ablation Catheter REF D141201. The Field Catheter is indicated for use in catheter based cardiac electrophysiological mapping (stimulating and recording) and, when used for TRUPULSE Generator, for the treatment of drug refractory recurrent symptomatic paroxysmal atrial fibrillation. The catheter provides location information when used with the CARTO 3 System.
Quantity: 497 total catheter - 378 US and 119 OUS
Why Was This Recalled?
Due to an observed trend of neurovascular events
Where Was This Sold?
This product was distributed to 10 states: AR, CA, CO, KS, LA, MA, MO, NY, OH, TX
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