FDA confirms new recall for Impella heart pump accessories

August 11, 2026 - 01:15

Johnson & Johnson MedTech, along with its manufacturing partner Oscor, has announced a new recall for certain accessory sheaths used with the Impella heart pump system. The companies said they received reports of the sheaths leaking, which could lead to bleeding at the access site in patients undergoing procedures.

The recall covers specific lots of the Impella introducer sheath kits, which are used to guide the heart pump into the artery. According to the U.S. Food and Drug Administration, the issue involves a potential separation or leak in the sheath's hub, which may cause blood loss and require additional medical intervention. In severe cases, this could lead to serious patient harm, including hemorrhage or the need for emergency surgery.

The FDA confirmed the recall as a Class I event, the agency's most serious classification. That designation means there is a reasonable chance the product could cause serious health problems or death. The affected devices were distributed to hospitals and medical centers across the country between late 2024 and early 2025.

Johnson & Johnson MedTech said it has notified healthcare providers about the issue and is working to collect the affected products. The company advises clinicians to check their inventory for the recalled lot numbers and stop using any remaining units immediately. Patients who have already undergone procedures with the affected sheaths should be monitored for signs of bleeding or other complications.

This is not the first time the Impella system has faced regulatory scrutiny. Earlier this year, the FDA issued a separate warning about the pump's catheter, citing a risk of perforation. The company says it is committed to patient safety and is cooperating fully with the FDA on both matters. Healthcare facilities with questions are being directed to contact their local sales representative or the company's customer support line.