FDA Issues Safety Alert Over Software Flaw in Johnson & Johnson's Abiomed Impella Controller Linked to 1 Death and 2 Injuries

On May 21, 2026, the FDA issued an early alert to notify the public of a high-risk software error in the automatic Impella Controller (AIC) by Abiomed, a Johnson & Johnson company.

This device is the primary user control interface of the Impella heart pump system, responsible for catheter control and alarm monitoring.

According to the information disclosed by the FDA, Abiomed, Inc. issued an urgent medical device recall (correction) notice to affected customers on May 14.

The triggering conditions for this issue are as follows:When a patient is treated with the left ventricular Impella device and the aortic implant signal shows no residual pulsation (<12 mmHg) for more than 80 minutes, an internal software error may cause the AIC to force a restart. Disabling the aortic implant signal and left ventricular pressure display does not prevent this restart.

During the restart, the AIC screen went black and no longer issued any alarms, and the Impella pump also stopped running for about 35 seconds. At this time, the patient lost circulatory system support, and catheter reflux might have occurred. After the AIC restarted, the pump automatically resumed the previous pressure level.

Abiomed reported that, as of now, the issue has resulted in two serious injuries and one death.Patients without other mechanical assistance face a higher risk of severe injury or death due to insufficient hemodynamic support.The company recommends that all AIC device users update the instructions for use, emphasizing that the product will not be discontinued, existing inventory can continue to be used, and a software update is under development.

Johnson & Johnson acquired Abiomed for $16.6 billion in 2022. Since the completion of the acquisition, the Impella platform and its controller have appeared multiple times in FDA public notices.

Previously, due to the risk of heart perforation associated with the left ventricular pump, this product line had already been issued a Class I recall notice, the highest level, by the FDA in January 2025.

Last autumn, Abiomed reported five serious injury incidents (no fatalities) related to AIC purge pressure issues. The problem manifested as cracks or failures in the purge fixture, which the company identified as partly caused by the force applied by users when installing or removing the purge plate.

In July 2025, the FDA notified medical institutions that Abiomed had issued updated instructions for use for all AICs. As of June 13, the company reported no serious injuries associated with this issue, but there were three deaths.

In August 2025, the FDA once again issued a warning to Abiomed, instructing customers to stop using or selling certain AIC products. According to a company spokesperson, the issue affects 69 AIC devices globally. As of August 12, the company reported one death associated with the issue and no other serious injuries.

In February this year, the FDA stated that Abiomed issued an urgent medical device correction notice, involving all Impella RP and Impella RP Flex devices equipped with Smart Assist functionality, stating thatThe sensor in this device may have a "drift" fault in its readings.Has cumulatively resulted in 22 serious injury reports.Later that month, the FDA issued another warning related to the Impella drainage box.