美国食品药品监督管理局(FDA)发布公告称,波士顿科学公司(Boston Scientific)已主动从市场撤回部分特定型号的Axios支架及其配套的电灼增强输送系统。
此次召回涉及的产品主要用于内镜下介入治疗,监管部门指出该行动属于预防性安全措施。目前公司正与医疗专业人员密切沟通,确保患者治疗流程的连续性。FDA建议已使用相关设备的医疗机构密切关注患者后续情况,并按要求完成产品追溯登记。
美国食品药品监督管理局(FDA)发布公告称,波士顿科学公司(Boston Scientific)已主动从市场撤回部分特定型号的Axios支架及其配套的电灼增强输送系统。
此次召回涉及的产品主要用于内镜下介入治疗,监管部门指出该行动属于预防性安全措施。目前公司正与医疗专业人员密切沟通,确保患者治疗流程的连续性。FDA建议已使用相关设备的医疗机构密切关注患者后续情况,并按要求完成产品追溯登记。
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