Johnson & Johnson Subsidiary Abiomed Recalls Impella Controllers Following Additional Fatality

Recently, after reporting a death case, Abiomed, a subsidiary of Johnson & Johnson Medical, recommended consumers to remove certain automatic controllers from the use or sales sites of its Impella heart pumps.

Source: Medtech Dive

Abiomed states that certain pump drive circuit components of some automated Impella controllers do not meet current specifications.

These pump drive circuit components contain tantalum capacitors rated at 25V instead of tantalum capacitors rated at 35V.This discrepancy may lead to decreased pump performance or pump stoppage, triggering "Impella Fault" or "Impella Stop Controller Fault" alarms, and may result in loss of circulatory support function or death.

"Controller Failure" Alarm

As of August 12, Abiomed reported one death and no serious injuries related to the issue. The FDA posted the information as part of its pilot project aimed at providing early warnings about potentially high-risk issues.

Abiomed sent a letter to all affected customers on August 20, advising them to quarantine and stop using the related products. Abiomed also recommended that customers contact the company to initiate the remediation process.

A Johnson & Johnson spokesperson said that Johnson & Johnson MedTech has identified a capacitor malfunction that may, in very rare cases, lead to reduced pump performance or pump stoppage, and has therefore decided to voluntarily recall (remove) 69 Automated Intra-Aortic Balloon Pump Controllers (AIC).

A review of complaints from January 2011 to June 2025 revealed a failure rate of 0.006%, with one complaint reporting a patient death.

The spokesperson added that the company will provide customers with borrowed automated Impella controllers.

Abiomed's Impella heart pump is used to reduce the workload of the left ventricle and provide support to the circulatory system, allowing the heart time to recover.

Johnson & Johnson acquired Abiomed for $16.6 billion in 2022. Since then, Abiomed has recalled multiple products due to Impella issues and received a warning letter in September 2023.

In June this year, Abiomed notified customers of another issue with the automated Impella controller, which was linked to three fatalities.