FDA将Impella心脏泵控制器问题定为最严重级Class I召回：约900台须移除待修
美国食品药品监管局（FDA）已将 Abiomed 公司 Impella 心脏泵控制器的一宗更新问题定为 Class I 召回，这是 FDA 最严重的召回级别，意味着继续使用涉事器械可能造成严重伤害或死亡。FDA 今年 9 月曾就这一问题发布早期警报；据心血管专业媒体 Cardiovascular Business 10 月 29 日引述 FDA 最新召回信息，这一问题现已正式定级为 Class I。
本次召回只涉及特定批次的三款控制器，合计约 900 台：Automated Impella Controller（包装版）428 台、Impella Optical Controller（包装版）179 台、Impella Connect Optical AIC 293 台。涉事设备应从使用与销售场所移除、等待维修；但如确为保障患者救治所必需，仍可继续使用。
FDA 的早期警报说明，Abiomed 在回顾维修记录后发现，部分控制器需要进行硬件、固件和（或）软件更新。已发现的质量问题包括：控制器在设置或更换时可能无法识别冲洗盒（purge cassette）；按键粘滞、不可靠，可能影响操作者选择与确认菜单、甚至失去对控制台的控制；系统不稳定可能导致启动失败；以及其他软件缺陷。
FDA 指出，若不完成上述更新，患者可能面临治疗延误、血流动力学支持不足或丧失等严重问题。Abiomed 已于 9 月 18 日致函全部受影响客户，建议将涉事控制器从使用与销售场所移除，并由公司服务团队联系客户，协调设备的移除、更新与返还。
截至 2026 年 9 月 8 日，Abiomed 报告称这一问题尚未关联任何严重伤害或死亡。FDA 同时提醒，在等待 Abiomed 提供服务期间，医院现有库存可继续使用，以确保救治的连续性。美国客户如有不良反应、质量问题或疑问，可拨打 Abiomed 现场服务团队电话 1-800-422-8666（选 3）咨询。
Automated Impella Controller 是 Impella 导管的主用户控制界面，负责控制导管并监测警报；Impella 疗法旨在减轻心脏负荷、为循环系统提供支持，让心脏获得恢复时间。Abiomed 现属强生医疗科技（Johnson & Johnson MedTech），强生于 2022 年以约 166 亿美元收购该公司。强生表示，公司与 FDA 紧密合作开展回顾性审查并实施质量系统改进；在落实必要更新期间，医院库存凭现有警报、监测与缓解措施可继续使用。
需要区分的是，本次定级的更新问题与 Abiomed 今年 8 月因冲洗旗标（purge flag）部件故障发起的另一宗控制器召回不是同一问题，FDA 对两宗召回分别建页通报，医院核对设备时应以序列号与 FDA 对应页面为准。
FDA Classifies Impella Heart Pump Controller Issue as Most Serious Class I Recall: About 900 Units to Be Removed for Service
The U.S. Food and Drug Administration (FDA) has categorized an update issue affecting Abiomed's Impella heart pump controllers as a Class I recall, the agency's most serious recall type, meaning continued use of the devices may cause serious injury or death. The FDA issued an early alert on the issue in September; according to Cardiovascular Business, which cited the FDA's latest recall information on October 29, the issue has now been formally classified as Class I.
The recall covers only specific lots of three controller models, about 900 units in total: 428 packaged Automated Impella Controllers, 179 packaged Impella Optical Controllers, and 293 Impella Connect Optical AIC units. The affected devices should be removed from where they are used or sold until they can be serviced; if absolutely necessary to ensure a patient receives care, however, they can still be used.
In its early alert, the FDA said a retrospective review of servicing records had identified certain Impella controllers that require hardware, firmware, and/or software updates. The quality issues include a potential failure to recognize the purge cassette during setup or change, a sticking and unreliable button that could affect the operator's ability to select and confirm menu entries and possibly cause loss of control of the console, instability that could result in start-up failure, and other software defects.
Without the updates, the FDA said, patients could face delay of therapy, inadequate or loss of hemodynamic support, and other serious issues. Abiomed sent a letter to all affected customers on September 18, 2026, and its service team will contact customers to coordinate the removal, update, and return of the devices.
As of September 8, 2026, Abiomed had reported no serious injuries or deaths associated with this issue. While awaiting service from Abiomed, hospital inventory can continue to be used to ensure continuity of care. U.S. customers with adverse reactions, quality problems, or questions can contact the Abiomed Field Service Team at 1-800-422-8666, option 3.
The Automated Impella Controller is the primary user control interface for the Impella catheters; it controls the catheter and monitors it for alarms. Impella therapy aims to reduce the work of the heart and provide circulatory support so the heart has time to recover. Abiomed is now part of Johnson & Johnson MedTech, which acquired the company in 2022 for about $16.6 billion. Johnson & Johnson said it worked closely with the FDA on retrospective reviews to implement quality system improvements, and that hospital inventory can continue to be used, with existing alarms, monitoring, and mitigation actions, while the necessary updates are implemented.
This update issue is distinct from a separate Abiomed controller recall begun in August over purge flag component failures; the FDA maintains separate pages for the two recalls, and hospitals should verify devices against the serial numbers and the corresponding FDA page.
来源：GSM·美国（原文链接）
图片来源：图：美国食品药品监管局（FDA）白橡树园区一号大楼。GSM联邦机构固定图库照片，经 Wikimedia Commons，公共领域。 / Photo: Building 1 of the U.S. Food and Drug Administration White Oak campus. GSM federal agency library photo, via Wikimedia Commons, public domain.
