Biosense Webster, Inc. is contacting users of the VARIPULSE™ Bi-Directional Ablation Catheter to inform that it has initiated a field safety notice and share updates to the Instructions for Use (IFU) for the VARIPULSE™ Bi-Directional Ablation Catheters as a result of neurovascular events that were reported in the US. These updates to the existing labeling include important updates on the device's risks. Recall start date: February 21, 2025
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