Notice
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VARIPULSE™ Bi-Directional Ablation Catheter
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- Identification number: RA-77016
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 Details
Starting Date: February 25, 2025
Description:
Summary
For more information on this recall, see the: VARIPULSE™ Bi-Directional Ablation Catheter
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The information provided on the recall section of this website is for general awareness only. While we strive for accuracy, users should verify details with official authorities. We are not responsible for any actions taken based on this information. See Disclaimer Policy for more details.
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