Impella Heart Pump Sensor Warning Issued by Abiomed After Nearly Two Dozen Injuries: FDA

Alert follows earlier recalls and lawsuits alleging that the Impella heart pump poses risks of heart-wall perforation and other severe complications that were not adequately disclosed.

Federal regulators are warning that certain Impella heart pumps may display inaccurate flow and positioning data due to a sensor malfunction, which could lead doctors to take unnecessary or inappropriate medical actions.

The U.S. Food and Drug Administration (FDA) announced the early alert on February 3, following at least 22 patient injuries linked to a malfunction that can cause the Automated Impella Controller to display incorrect pump flow rates and misleading placement signals.

Impella devices are temporary heart pumps designed to support patients with acute right-sided heart failure by assisting blood flow from the inferior vena cava into the pulmonary artery. Physicians rely heavily on real-time data displayed on the controller to guide treatment decisions, including pump speed adjustments and placement verification.

This is not the first time that Abiomed’s Impella pumps have faced a serious safety issue. Prior recalls and Impella heart pump lawsuits suggest that the systems may also carry a risk of heart-wall perforations and other severe complications, which may not have been adequately disclosed to patients and the medical community.

The Impella heart pump’s manufacturer, Abiomed, issued an urgent medical device correction on January 27, warning that a differential pressure (dP) sensor used in certain Impella RP heart pumps may experience signal drift, leading to inaccurate readings for pump flow and placement indicators. The company reported the issue in about 2.5% of cases worldwide, with roughly 0.5% involving pump or console exchanges after clinicians acted on faulty data.

Abiomed said the issue does not affect the pump’s ability to provide circulatory support and that the devices can remain in use. However, clinicians are being advised not to rely solely on the controller’s display and instead use flow tables in the device’s Instructions for Use along with imaging tools. The company has submitted updated labeling to the FDA.

The alert refers only to Impella RP and Impella RP Flex models equipped with SmartAssist technology. Affected devices have the following product codes and unique device identifiers (UDIs):

• Impella RP with SmartAssist, Product Code: 0046-0035, UDI: 00813502011869
• Impella RP Flex with SmartAssist, Product Code: 1000323, UDI: 00813502012811

Other Impella devices, including the Impella 5.5 and Impella CP, are not affected by the issue. To date, at least 22 injuries have been reported in connection with the impacted devices. 

Any U.S. customers with adverse reactions, quality problems or questions may contact Abiomed Inc. at onemed-field-actions@its.jnj.com.

Adverse events and other quality concerns may also be reported to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program.

Impella Heart Pump Recalls

In addition to these concerns about Impella heart pump sensors, the devices have also been subject to numerous prior recalls.

In October 2025, federal regulators announced a recall of certain Automated Impella Controllers, due to a cybersecurity vulnerability that could allow unauthorized system access and potentially lead to life-threatening injuries for patients.

Earlier that year, Impella RP and Impella RP Flex Heart Pumps with SmartAssist were recalled as well, due to the risk of contact between guidewires and other medical instruments, which could cause the heart pumps to shut down unexpectedly.

Abiomed also recalled Impella Left Sided Blood Pumps in March 2023, after reports indicated the devices had caused nearly 50 deaths and about 130 injuries due to heart ventricle perforations.

A separate recall involved Impella 5.5 with SmartAssist pumps after purge fluid leaks were linked to device failures, heart valve damage and serious patient injuries. The issue was associated with 179 reported complaints.

The FDA also announced a Class I recall for Impella RP Flex catheter systems in June 2023, citing inadequate safety instructions about the risk of blood clots that had already resulted in 12 injuries.

In the wake of these actions, injured patients have begun pursuing potential Impella heart pump lawsuits, presenting claims that Abiomed knew about the devices’ safety issues yet failed to warn doctors and patients.

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