波士顿科学公司因严重伤害和死亡的报道而召回POLARx导管. Boston Scientific issues a high-risk recall for POLARx catheters due to reports of severe injuries and deaths.

波士顿科学公司在报告了严重食管损伤（包括 7 例受伤和 4 例死亡）后，正在更新其用于心房颤动治疗的 POLARx 冷冻消融导管的说明。 Boston Scientific is updating instructions for its POLARx cryoablation catheters used in atrial fibrillation treatments after reports of severe esophageal injuries, including seven injuries and four deaths. 由于未遵守最新指南,可能导致严重健康问题或死亡, FDA 将其归类为I类召回, The FDA classified this as a Class I recall, the most serious type, due to the risk of severe health issues or death if the updated guidelines are not followed. 新的指令强调了前庭食管的风险, 并提供在手术期间尽量减少这种风险的做法. The new instructions emphasize the risk of atrio-esophageal fistula and provide practices to minimize this risk during procedures.