Correction of the LeVeen™ Needle Electrode from Boston Scientific
2005.09.12
Product group Medical electronics / Electromedical devices
Reference 02127/05
The company Boston Scientific notified of an urgent medical device correction of the LeVeen™ 5,0 cm Needle Electrode due to reports citing extended ablation times, lack of roll-off and superficial pad burns. The manufacturer modified an algorithm in the Directions for Use. In addition, the revised Directions for Use include precautionary information related to monitoring of patient return pads.
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