Blood may leak out of Impella introducers due to manufacturing defect
The U.S. Food and Drug Administration (FDA) sent an early alert this week to warn of possible unexpected bleeding risks with Johnson & Johnson MedTech Impella percutaneous heart pump introducer sheaths.
This is a new Impella issue recently discovered by users. As of April 22, the company said it had eight clinical reports of major bleeding and three reports of patient deaths possibly related to the issue. But Johnson & Johnson MedTech said it determined the deaths were not due to introducer leakage.
The company found there is potential for introducer sheath leakage in 14 French and 23 French introducers from the sidearm, under the sheath cap and along the hub score lines in the hub region. These areas are unexpected leakage locations, the cause is evidently due to manufacturing issues. The FDA said Johnson & Johnson MedTech and its manufacturing partner Oscor issued a letter to customers recommending all introducer kits used with Impella heart pumps be corrected prior to continued use.
FDA said introducer leakage may result in access site bleeding at the time of sheath insertion or early device manipulation. This may cause blood loss requiring medical intervention, such as device exchange or removal, manual compression and, in some cases, a blood transfusion.
In some circumstances, the FDA said, patients undergoing large-bore vascular access with systemic anticoagulation may suffer life-threatening hemorrhage and hemodynamic instability.
The FDA said it is currently reviewing information about this potentially high-risk danger and will post any significant, new information as it becomes available.
"The safety and care of our patients is our top priority and we continuously assess our quality management systems to ensure the most rigorous safety and technical standards," Johnson & Johnson MedTech said in a statement to Cardiovascular Business about the early alert. "Recent field actions reflect that our quality systems are working as designed and demonstrate our commitment to the continuous monitoring and safety of our life-saving products."
Hospitals are being told they can continue using existing inventory, but they need to be aware of the issue and ready to either exchange the device or use the repositioning sheath to minimize blood loss if leakage occurs.
On June 10, 2026, Johnson & Johnson MedTech and Oscor sent all affected customers a letter recommending the following actions:
- Physicians should continue to use appropriate clinical awareness, monitoring and patient support as needed.
- Consider a device exchange or using the repositioning sheath to minimize blood loss if potential leakage from the sidearm and under the sheath cap and along the hub score lines in the hub region is observed.
- Forward the firm’s notice to anyone in your facility who manages, transports, stores, stocks or uses the subject products. Post a copy of the firm’s notice in a visible area for awareness.
- If any of the subject products have been forwarded to another facility, contact that facility and provide them with the firm’s notice.
There have been numerous, recent recalls on the Impella system for various issues.
Read more about the issues in the related content below.
Dave Fornell has covered healthcare for more than 17 years, with a focus in cardiology and radiology. Fornell is a 5-time winner of a Jesse H. Neal Award, the most prestigious editorial honors in the field of specialized journalism. The wins included best technical content, best use of social media and best COVID-19 coverage. Fornell was also a three-time Neal finalist for best range of work by a single author. He produces more than 100 editorial videos each year, most of them interviews with key opinion leaders in medicine. He also writes technical articles, covers key trends, conducts video hospital site visits, and is very involved with social media. E-mail: [email protected]