The Impella RP Flex with SmartAssist. [Image from Abiomed]

带有SmartAssist的Impella RP Flex。[来自Abiomed的图像]

The FDA today issued a notice informing customers of updated instructions for the

FDA今天发布了一份通知，告知客户关于

Johnson & Johnson MedTech

强生医疗技术公司

Abiomed

比奥梅德

Impella RP heart pump.

Impella RP心脏泵。

Impella RP offers up to 14 days of use in patients who develop acute right heart failure after left ventricular assist device (LVAD) implantation. Placed in the internal jugular vein, it supports the right chamber of the heart by pumping blood into the pulmonary artery.

Impella RP在左心室辅助装置（LVAD）植入后发生急性右心衰竭的患者中使用长达14天。它位于颈内静脉，通过将血液泵入肺动脉来支撑右心室。

Abiomed updated instructions for certain Impella RP devices but the recall doesn’t involve removing them from where they are used or sold. The FDA

Abiomed更新了某些Impella RP设备的说明，但召回并不涉及将其从使用或销售地点移除。FDA

identified

已识别

the recall as the most serious type. It can cause serious injury or death if customers continue using the device without following the updated instructions.

召回是最严重的类型。如果客户不按照更新后的说明继续使用该设备，可能会导致重伤或死亡。

The company said it received no reports of injury or death related to this issue to date. It marks another recall for the Impella pumps. A separate version

。这标志着Impella泵的又一次召回。单独的版本

had a recall last year

去年被召回

that included 49 related deaths. This version, the RP, previously

其中包括49例相关死亡。这个版本，RP，以前

had a Class I recall in 2023

2023年有一次I级回忆

as well.

也一样。

Abiomed in December issued an urgent medical device correction notification to affected customers. It related to issues with all Impella RP with Smart Assist and the Impella RP Flex with SmartAssist devices.

Abiomed于12月向受影响的客户发布了紧急医疗器械整改通知。它涉及所有带智能辅助的Impella RP和带智能辅助设备的Impella RP Flex的问题。

The company identified a risk of the tip of guidewires or other medical devices coming into contact with the Impella pump during insertion, adjustment or removal. This could result in optical sensor damage, temporary pump stop or permanent pump stop. That could trigger alarms and cause a loss of certain heart and blood pressure readings..

该公司发现，在插入、调整或拆卸过程中，导丝尖端或其他医疗设备有接触Impella泵的风险。这可能导致光学传感器损坏、临时停泵或永久停泵。这可能会触发警报，并导致某些心脏和血压读数的丢失。。