FDA shares another warning about Impella heart pumps after death
The U.S. Food and Drug Administration (FDA) is once again warning the public about a safety concern with Johnson & Johnson MedTech’s line of Impella heart pumps.
This latest alert was put in place after the company learned that certain Impella CP sets with SmartAssist “do not meet design specifications” and could experience a low purge pressure event.
“Exposure to the low purge pressure occurrence may result in persistent low purge pressure alarms and, in some cases, interruption or loss of mechanical circulatory support,” according to the FDA’s advisory. “Loss of support may lead to an acute change in care when the pump is exchanged, hypotension, end organ hypoperfusion, and risk of death if not promptly corrected.”
One patient died as a result of this issue.
The Impella CP with SmartAssist is a temporary heart pump used during high-risk percutaneous coronary intervention procedures and to treat patients in cardiogenic shock. The only serial numbers impacted by this issue are 613525, 644314, 645428, 644591, 672986, 673252 and 677223.
What should customers do?
The Impella devices impacted by this alert should not be used to treat any heart patients. Customers have been warned to quarantine any affected sets and return them.
Click here for more details from the FDA. At this time, the agency is still reviewing details and has not yet determined the severity of the recall. This early alert is part of a new FDA policy designed to keep the public informed about any potential issues right away.
Johnson & Johnson shares some context
"At Johnson & Johnson, patient safety is our top priority, which is why we have initiated a voluntary device recall of seven specific Impella CP sets with SmartAssist in the U.S.," a company spokesperson told Cardiovascular Business. "An internal review found that these seven units do not meet design specifications, leading to the potential for low purge pressure events. We are notifying impacted customers and working to issue a credit."
The company also emphasized that a review of all global complaints from 2024 to April 2026 only identified the issue in 0.01% of all cases.
Johnson & Johnson said it has been performing "comprehensive, retrospective audits" of its quality systems and processes, and some of those audits have resulted in field actions.
"These field actions do not compromise the safety of the products in use today," the spokesperson told Cardiovascular Business. "Rather, they demonstrate that our enhanced processes are rigorous and working as intended. The net result is our continued ability to lead the field of acute mechanical circulatory support with the highest quality, life-saving products designed to treat some of the sickest patients in the hospital while protecting patient safety."
Another serious safety concern for the Impella platform
Johnson & Johnson MedTech’s Impella devices have been associated with a significant number of recalls and safety alerts. In the last several months alone, Automated Impella Controller (AIC) issues were linked to one recall in July 2025, a second recall in September 2025, a third and fourth recall in October 2025, a fifth recall in December 2025 and a sixth recall in May. In April, meanwhile, the FDA announced a separate recall related to a risk of purge cassettes leaking.
In addition, the FDA shared an additional alert about the AICs on May 21.
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.