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Biosense Webster, Inc. recalls VARIPULSE Bi-Directional Ablation Catheter REF D141201. The Field Catheter is indicated for use in catheter based
Recalled March 12, 2025 · FDA recall Z-1205-2025 · Biosense Webster
Hazard
Due to an observed trend of neurovascular events · FDA Class I
Units
497 total catheter - 378 US and 119 OUS
Sold at
Worldwide distribution; US states of AR, CA, CO, KS, LA, MA, MO, NY, OH and TX. EMEA, New Zealand, Saudi Arabia, Oman, United Ecuador, Panama, South Africa, China Austria Belgium Czech Republic France Germany Hungary Ireland Israel Italy UK Sweden Norway Denmark Finland Luxembourg Netherlands Poland Portugal Slovenia Spain Switzerland Serbia United Arab Emirates Croatia Canada South Korea Japan
Description
Due to an observed trend of neurovascular events
Product
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.
Manufacturer(s)
Biosense Webster, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →