FDA confirms new recall for Impella heart pump accessories
The U.S. Food and Drug Administration (FDA) has finalized a new recall related to an issue with certain Johnson & Johnson MedTech introducer sheaths.
These devices are used to introduce Impella heart pumps to the bodies of patients. Johnson & Johnson MedTech and Oscor, the company’s manufacturing partner, received multiple reports of the sheaths leaking in ways that could result in access-site bleeding.
If leakage does occur, it would come from the device’s sidearm or under the sheath cap. This issue has only been seen with specific lots of 14 and 23 French introducer kits compatible with the Impella RP Flex with SmartAssist, Impella RP Set with SmartAssist, Impella 5.5 Set with SmartAssist, and Impella CP Set.
Safety issue now confirmed to be a Class I recall
The FDA first warned the public about this issue back in June as part of its Early Alert Pilot Program. The agency was still reviewing the situation at that time, and no final decisions had been made about the severity of the recall.
Now, the FDA has determined this is a Class I recall, which means using the devices could cause “serious adverse health consequences or death”
“Introducer leakage may result in access site bleeding at the time of sheath insertion or early device manipulation,” according to the FDA’s advisory. “This may cause blood loss requiring medical intervention, such as device exchange or removal, manual compression, and, in some cases, blood transfusion. In certain circumstances, particularly patients undergoing large bore vascular access with systemic anticoagulation or limited physiologic reserve (with a bleed that went undetected), exposure to this hazard may result in life-threatening hemorrhage and hemodynamic instability which may lead to death.”
Image courtesy of the FDA.
Recall does not require devices to be returned
Unlike many recalls, these devices do not need to be returned to the manufacturer. However, customers are advised to “use appropriate clinical awareness, monitoring and patient support as needed.” The FDA also suggested customers “consider a device exchange” or use a repositioning sheath if potential leakage is identified at any point during a procedure.
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Another recall for the Impella platform
Johnson & Johnson MedTech’s Impella devices have been associated with multiple recalls and safety alerts in recent years. 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, third and fourth recalls in October 2025, a fifth recall in December 2025 and a sixth recall in May.
In April, the FDA announced a separate recall related to a risk of purge cassettes leaking. Approximately two months later, the agency warned that certain 14 French low profile introducer kits were recalled due to a risk of thrombus formation.
Johnson & Johnson acquired Abiomed in 2022
Impella heart pumps were originally 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.