FDA warns that Johnson & Johnson heart pump sensors may malfunction—22 injuries reported
The U.S. Food and Drug Administration (FDA) is warning the public about a new safety issue associated with Johnson & Johnson MedTech’s Impella RP with SmartAssist and Impella RP Flex with SmartAssist devices. This is not a device removal, but all instructions for use (IFU) have been updated with important information.
These temporary heart pumps were designed to provide right heart support to patients with acute right heart failure. According to this new warning from the FDA, however, there is a risk that some of the recordings being shared with users may not be accurate due to malfunctioning differential pressure (dP) sensors.
“The dP sensor measures the pressure difference between the inlet and outlet of the pump and is used to calculate these displayed values,” according to the FDA advisory. “There is no way to confirm error in the flow calculation directly from the pump signals when sensor drift occurs. Inaccurate displayed information on the Automated Impella Controller (AIC) has resulted in the user making clinical interventions including inaccurate P-level adjustments or unnecessary pump exchanges. However, the dP sensor does not affect the device’s ability to provide hemodynamic support.”
Because the AIC display may be showing incorrect information, customers using these devices are urged to refer to the specific P-level flow rates listed on their instructions for use (IFU). In addition, the FDA’s alert emphasized that pump performance should be closely monitored.
“An abrupt change in flow or abrupt discrepancy from the expected flow rate listed in the IFU may indicate a need to reassess pump positioning and performance, patient conditions and clinical hemodynamics,” according to the advisory.
A total of 22 injuries have been linked to this issue.
This early alert from the FDA is part of the agency’s new program to keep the public informed about potential safety issues while they are still under investigation. Cardiovascular Business will provide an update when the FDA has finalized any recalls.
Johnson & Johnson acquired Abiomed in 2022
The Impella line of heart pumps were previously sold under the Abiomed brand before Johnson & Johnson acquired Abiomed in 2022 for approximately $16.6 billion. In 2024, Abiomed started operating under the name Johnson & Johnson MedTech.
Michael has more than 19 years of experience as a professional writer and editor. He has written at length about cardiology, radiology, artificial intelligence and other key healthcare topics.