During investigational testing of the Habib™ Catheter with the ERBE VIO 3 generator (compatible 3rd party device), an issue with the generator setting in the Habib™ IFU (50738103) was identified. From the results of this testing, it was determined that the VIO 3 setting produces results that do not meet the dimensional requirements identified for the ablation heating zone in the Habib™ design matrix (92252607). Recall start date: March 2, 2023
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