FDA confirms another recall for Johnson & Johnson’s Impella heart pumps
The U.S. Food and Drug Administration (FDA) has confirmed a new recall of the purge cassettes sold with certain Johnson & Johnson MedTech Impella heart pumps. The alert covers individually packaged Generation 1 Purge Cassettes as well as the ones sold with certain Impella RP, Impella 2.5, Impella CP, Impella CP with Smart Assist, Impella 5.0 and Impella 5.5 with Smart Assist heart pumps.
The FDA issued this recall due to a risk of the purge cassettes leaking. Purge cassettes play a critical role in patient care, delivering a rinsing fluid to the catheter that prevents blood from flowing back into the motor.
“A purge leak may lead to low purge pressure if it goes unaddressed,” according to Johnson & Johnson MedTech. “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.”
The leaks have been linked to four serious injuries and no deaths.
What customers need to know
In total, more than 33,000 devices are impacted by this recall. Customers have been urged to remove all Generation 1 Purge Cassettes, return them to the manufacturer and order Generation 2 Purge Cassettes as needed. However, no complete Impella heart pumps should be returned to the manufacturer; only the cassettes.
If such a leak does occur during use, a “Purge Pressure Low” alarm will be displayed on the Automated Impella Controller (AIC). That alarm will include key steps the clinician should take.
Click here for a Johnson & Johnson MedTech video from 2020 showing customers how to change out the purge cassette when necessary.
Image courtesy of Johnson & Johnson MedTech.
Details about potential leaks first shared with public in February
The FDA warned the public about this issue in February.
At the time, the agency was still reviewing the situation and had not determined the severity of the recall. Now, however, this has officially been ruled a Class I recall, which means using the devices could lead to “serious adverse health consequences or death.”
The full FDA warning from February is available here.
Impella devices linked to a variety of safety concerns
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. A separate recall related to these devices was announced in March.
Johnson & Johnson acquired Abiomed in 2022
The Impella line of heart pumps was 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.