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Cardiac Pacemakers, Incorporated, a wholly owned subsidiary of Guidant Corporation, a wholly owned subsidiary of Boston Scientific Corporation对植入式心脏再同步治疗起搏器(商品名:Inliven)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心脏再同步治疗起搏器(商品名:Inliven)的托盘标签和外箱标签上印有错误的电极导线连接信息,生产商Cardiac Pacemakers, Incorporated, a wholly owned subsidiary of Guidant Corporation, a wholly owned subsidiary of Boston Scientific Corporation对其生产的植入式心脏再同步治疗起搏器(商品名:Inliven)〔注册证编号:国食药监械(进)字2014第3212958号〕主动召回。召回级别为三级。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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