FDA highlights recall of certain Impella introducer kits after 3 injuries
The U.S. Food and Drug Administration (FDA) has shared a new safety alert related to Johnson & Johnson MedTech’s line of Impella heart pumps. This voluntary recall covers certain 14Fr Low Profile Introducer Kits used to facilitate access to a patient’s vascular system for the introduction and removal of the Impella CP with SmartAssist device.
Johnson & Johnson MedTech found that these introducer kits were associated with an increased risk of thrombus formation. Three serious injuries have been linked to the issue.
“Thrombus formation within the indwelling sheath lumen or the annular gap between the sheath inner diameter and the catheter outer diameter during prolonged support may result in disruption of blood flow near the access site,” according to the FDA’s advisory. “If thrombus is dislodged during ongoing support, manipulation or removal, this may result in peripheral vessel obstruction with ischemia requiring prompt clinical assessment and intervention to restore perfusion. Under less common circumstances, exposure could progress to irreversible vascular occlusion with potential for permanent impairment if not corrected.”
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. This specific warning does not impact the actual heart pump—only the 14Fr Low Profile Introducer Kits. However, because the 10th generation of the Impella CP with SmartAssist devices is only compatible with these introducer kits, the heart pumps themselves are also included in this recall.
Six hospitals impacted by this issue
In a statement to Cardiovascular Business, Johnson & Johnson emphasized that this thrombus risk only impacts technologies available at six hospitals.
“Patient safety is our top priority, and we are working with the six impacted hospitals in the U.S. to return the product and issue credits,” a company representative explained.
What should customers do?
These devices should not be used to treat patients. Customers have been warned to review their inventory and quarantine any devices included in this recall.
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.
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, third and fourth recalls 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 and a separate alert about certain Impella CP with SmartAssist devices on May 29.
Johnson & Johnson acquired Abiomed in 2022
The Impella line of heart pumps was 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.