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Cardiac Pacemakers, Incorporated, a wholly owned subsidiary of Guidant Corporation, a wholly owned subsidiary of Boston Scientific Corporation对植入式起搏电极导线、植入式心脏起搏电极导线主动召回
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波科国际医疗贸易(上海)有限公司报告,由于该公司代理的植入式起搏电极导线、植入式心脏起搏电极导线在术者转动电极导线的尾端插头时,如果转动的圈数超过最大圈数(三十圈),将有可能造成导体线圈断裂,生产商Cardiac Pacemakers, Incorporated, a wholly owned subsidiary of Guidant Corporation, a wholly owned subsidiary of Boston Scientific Corporation对其生产的植入式起搏电极导线(注册证编号:国械注进20143216007)、植入式心脏起搏电极导线(注册证编号:国械注进20163213099)主动召回。召回级别为二级。涉及产品的型号、规格及批次等详细信息见《医疗器械召回事件报告表》。(来源:CFDA)
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