美国食品药品管理局11月9日将Abiomed自动Impella控制器移除定级为一级召回：涉三款控制器型号，截至9月8日无严重伤害或死亡报告
华盛顿 — 美国食品药品管理局 11 月 9 日更新通告称，Abiomed 公司自动 Impella 控制器的移除事项已被定级为一级召回。该局说明，这类召回属于最严重类型，继续使用相关器械可能造成严重伤害或死亡，本次召回涉及把产品从使用或销售地点移除。
受影响产品为三款自动 Impella 控制器，产品编号分别为 0042-0000-US、0042-0010-US 与 0042-0040-US，仅限特定主机。Abiomed 已于 9 月 18 日致信受影响客户，建议移除相关控制器。
该局转述 Abiomed 的说明称，企业回顾维修记录后发现，部分 Impella 控制器需要硬件、固件或软件更新，以处理可能涉及安全的质量问题。
截至 2026 年 9 月 8 日，Abiomed 报告尚无与这一问题相关的严重伤害或死亡。时间线方面，食品药品管理局于 9 月 23 日就这一潜在高风险器械问题发出早期警示，11 月 9 日更新通告告知公众定级结果，受影响产品与建议做法没有改变。本稿只转述通告事实，不作个体诊疗建议。
FDA Classifies the Abiomed Automated Impella Controller Removal as a Class I Recall on November 9: Three Controller Models Affected, With No Serious Injuries or Deaths Reported as of September 8
Washington — The Food and Drug Administration updated its communication on November 9 to say the Abiomed Automated Impella Controller removal has been classified as a Class I recall. The agency says this is the most serious type of recall, the device may cause serious injury or death if use continues, and this recall involves removing devices from where they are used or sold.
The affected products are three Automated Impella Controller models, product numbers 0042-0000-US, 0042-0010-US and 0042-0040-US, limited to specific consoles. Abiomed sent a letter to affected customers on September 18 recommending removal.
The agency relays Abiomed statement that a retrospective review of servicing records identified certain controllers requiring hardware, firmware or software updates to address quality issues with potential safety implications.
As of September 8, 2026, Abiomed had reported no serious injuries or deaths associated with this issue. On the timeline, the FDA issued an Early Alert on September 23 about the potentially high risk device issue, and updated the communication on November 9 with the classification, with affected products and recommendations unchanged. This report relays only the facts in the communication, without individual treatment advice.
发布：GSM·美国（发布链接）
图片来源：食品药品监督固定图库（GSM asset-packs）
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