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.

Due to an observed trend of neurovascular events

On 01/05/2025, the firm called and emailed customers to inform them to pause the US External Evaluations and all Varipulse cases due an observed trend in neurovascular events associated with the use of the VariPulse Bi-Directional Ablation Catheters distributed between December 2024 and January 2025. For U.S. Customers, Biosense Webster/JNJ Medtech EP is pausing the US External Evaluation and all US Varipulse cases. Healthcare providers who have treated patients using the products prior to the pause should continue to follow those patients according to their standard of care. For any questions, contact Biosense Webster/JNJ MEDTECH EP representatives On 01/08/2025, the firm released the information on the firm's parent company's website https://www.jnj.com/media-center/press-releases/johnson-johnson-statement-on-varipulse-u-s-external-evaluation