Johnson & Johnson’s

强生公司

JNJ

强生公司

Abiomed has issued an Early Alert regarding its Automated Impella Controllers (AIC) for Impella heart pumps, a device crucial for patients with severe heart conditions. This alert, issued by the Food and Drug Administration (FDA), highlights a critical safety concern following reports of three deaths..

Abiomed 发布了关于其用于 Impella 心脏泵的自动控制器 (AIC) 的早期预警，该设备对严重心脏疾病患者至关重要。这一由食品和药物管理局 (FDA) 发布的警告强调了在报告三例死亡后的一项关键安全问题。

What happened?

发生了什么？

Last week, the FDA announced it was aware that Abiomed had sent a letter to affected customers recommending updated instructions for use for all Automated Impella Controllers (AIC).

上周，FDA 宣布已知悉 Abiomed 向受影响客户发送了一封信，建议对所有 Automated Impella Controllers (AIC) 的使用说明进行更新。

Abiomed identified an issue where the AIC may fail to detect an Impella pump when connected. This pump detection

Abiomed 发现了一个问题，即当 AIC 连接 Impella 泵时可能无法检测到该泵。此泵检测

issue

问题

can occur during console-to-console transfer or at the start of a case. Critically, the AIC screen does not display a visual alarm to indicate this detection problem.

可能在控制台之间传输或案例开始时发生。关键在于，AIC屏幕并未显示视觉警报来指示此检测问题。

Also Read:

另请阅读：

Johnson & Johnson’s Abiomed Unit Recalls Instructions For Some Impella Blood Pumps Due To Cutting Risks

强生公司旗下Abiomed部门因切割风险召回部分Impella血液泵的使用说明

Abiomed has advised users to be vigilant for specific signs. If the screen freezes for more than 20 seconds after connecting the pump to a transferred console and doesn’t advance, users should immediately switch the pump back to the original console to support the patient. However, if the original console shows an alarm, users should switch to a different console instead.

Abiomed 已建议用户警惕特定迹象。如果在将泵连接到转移后的控制台后屏幕冻结超过 20 秒且无进展，用户应立即将泵切换回原始控制台以支持患者。然而，如果原始控制台显示警报，用户则应切换到另一个控制台。

Another potential problem occurs at the beginning of a procedure when the screen freezes while showing connection information; if the screen doesn’t advance to “Detecting Impella” after 20 seconds, users are advised to move the pump to a different console..

另一个潜在问题发生在过程开始时，屏幕在显示连接信息时冻结；如果屏幕在20秒后没有进入“检测Impella”界面，建议用户将泵移动到另一个控制台。

To mitigate risks, Abiomed recommends keeping a backup controller readily available. The company has stated that device failure itself is unlikely. While the FDA has not yet classified this as a formal recall (e.g., Class I, II, or III), it has issued an Early Alert, which is typically used for issues that could pose serious risks..

为了降低风险，Abiomed 建议随时准备一个备用控制器。该公司表示，设备本身出现故障的可能性不大。虽然美国食品药品监督管理局 (FDA) 尚未将此事件归类为正式召回（例如 I 类、II 类或 III 类），但已发布早期警告，该警告通常用于可能带来严重风险的问题。。

Why It Matters?

为什么这很重要？

The Automated Impella Controller serves as the primary user interface for the Impella Catheter, which is part of a blood pump system providing temporary full or partial heart support.

自动Impella控制器作为Impella导管的主要用户界面，该导管是提供临时全心或部分心脏支持的血泵系统的一部分。

This system helps patients maintain hemodynamic stability during adjunctive procedures or temporarily unloads the heart to aid recovery from acute conditions.

该系统帮助患者在辅助手术期间保持血流动力学稳定，或暂时减轻心脏负荷以帮助急性病症的恢复。

The identified issue with the AIC, the failure to detect the pump, can lead to inadequate hemodynamic support. This poses a significant risk, particularly for patients in cardiogenic shock, as prolonged periods of insufficient support can be life-threatening.

确定的AIC问题，即未能检测到泵，可能导致血流动力学支持不足。这带来了显著的风险，尤其是对于心源性休克患者，因为长时间的支持不足可能危及生命。

As of June 13, Abiomed has reported no serious injuries and three deaths associated with this issue.

截至6月13日，Abiomed报告称与此问题相关的严重伤害为零，死亡三例。

Previous Class I Recall

以前的I类召回

It is important to note that this is not Abiomed’s first safety concern regarding its Impella devices. Previous issues include

需要注意的是，这并非Abiomed公司首次对其Impella设备提出安全关切。之前的问题包括

perforation risks

穿孔风险

with the Impella catheter itself (which was classified as a Class I recall by the FDA in March 2024, linked to 49 deaths and 129 serious injuries) and problems with purge fluid leaks.

由于Impella导管本身（该产品在2024年3月被FDA列为I类召回，与49例死亡和129例严重伤害相关）以及冲洗液泄漏问题。

Johnson & Johnson

强生公司

acquired

获得的

Abiomed in 2022. These repeated alerts and recalls highlight the inherent complexities and risks associated with highly advanced, life-supporting medical devices, and the ongoing need for vigilant monitoring and improvements by both manufacturers and regulatory bodies.

2022年，Abiomed公司。这些反复的警示和召回突显了高度先进、维持生命医疗设备所固有的复杂性和风险，以及制造商和监管机构对这些设备进行持续警惕监控和改进的必要性。

Price Action:

价格行为:

JNJ stock is trading lower by 0.18% to $155.73 at last check Monday.

周一最新检查时，JNJ股票下跌0.18%，交易价格为155.73美元。

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Read Next:

阅读下文：

UnitedHealth, Centene Hit Hard By Guidance Shock, Trump’s Medicaid Push

联合健康、Centene因指导性预测冲击和特朗普的医疗补助推动而遭受重创

Photo by Tada Images via Shutterstock

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