FDA shares new warning about Johnson & Johnson heart pumps after 4 injuries
The U.S. Food and Drug Administration (FDA) is warning the public about a new safety concern with some of Johnson & Johnson MedTech’s Impella heart pumps. The alert covers certain Impella RP US Pump Sets as well as earlier models of the Impella purge cassettes.
The FDA issued this warning due to a risk of the Generation 1 Purge Cassettes leaking. These are a crucial part of the Impella heart pumps, delivering a rinsing fluid to the catheter that prevents blood from flowing back into the device’s motor. If such a leak does occur, a “Purge Pressure Low” alarm should be displayed on the Automated Impella Controller (AIC).
“A purge leak may lead to low purge pressure if it goes unaddressed,” according to the FDA advisory. “This can lead to biomaterial ingress, which may lead to an unexpected pump stop. A pump stop may result in a loss of hemodynamic support and lead to patient death.”
As of Feb. 3, this issue has been linked to four serious injuries and no deaths.
What customers with affected Impella devices should do
On Feb. 18, Johnson & Johnson MedTech sent a letter to all affected customers. The company emphasized that Generation 1 Purge Cassettes should no longer be used; a Generation 2 Purge Cassette should be used instead. If no Generation 2 devices are available, the company told customers to closely watch the device during use and refer to the instructions for use (IFU) if a “Purge Pressure Low” alarm is triggered.
Click here for more details from the FDA. At this time, agency is still reviewing this situation, so no recalls have been officially announced. This early alert is part of a new FDA policy designed to keep the public informed about any potential issues right away.
History repeating: Impella devices linked to several safety concerns over the years
Johnson & Johnson MedTech’s Impella platform has been associated with a significant number of recalls and safety alerts. In the last several months alone, AIC issues were linked to one recall in July 2025, a second recall in September 2025, a third and fourth recall in October 2025 and then a fifth recall in December 2025. In addition, the FDA shared a warning in February 2026 that certain Impella sensors may malfunction and the IFU had to be updated.
Johnson & Johnson acquired Abiomed in 2022
The Impella line of heart pumps were designed to provide right heart support during the treatment of high-risk percutaneous coronary intervention patients with acute right heart failure.
They 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.