Product Advisories | 合法醫療器材資訊網

AProductAdvisoryisavoluntaryletterissuedtoinformphysiciansofananomalousdevice...June2021EMBLEMElectrode3501RemovalPhysicianLetter.

A Product Advisory is a voluntary letter issued to inform physicians of an anomalous device behavior identified by Boston Scientifics Quality System.

A Product Advisory is issued when there is a material elevation in risk to patient safety with potential for compromised lifesaving therapy, or when Boston Scientific can provide meaningful guidance to improve patient outcomes or device performance.

FARAWAVE Pulsed Field Ablation Catheter and FARASTAR Pulsed Field Ablation Generator - September 2022 Advisory