The US Food and Drug Administration (FDA) has issued an early alert over a ‘potentially high-risk’ leakage issue associated with Abiomed’s Impella heart pump introducer kits, representing the latest troubles for the company’s product line.
Abiomed’s introducer kits serve as a vascular access pathway to allow for the insertion and positioning of its Impella heart pump catheter into a patient’s arteries.
Discover B2B Marketing That Performs
Combine business intelligence and editorial excellence to reach engaged professionals across 36 leading media platforms.
Abiomed has identified a potential for introducer sheath leakage in 14Fr and 23Fr introducers from the sidearm, under the sheath cap, and along the hub score lines in the hub region.
As per the FDA alert, unexpected leakage in these locations is due to ‘manufacturing issues’ that increase the risk of access-site bleeding. Should this issue occur, users would see blood loss at the sidearm and hub of the introducer sheath, with leak locations the same in both catheters.
Introducer leakage can potentially result in access site bleeding at the time of sheath insertion or following early device manipulation. Such an issue is particularly dangerous for patients undergoing large-bore vascular access with systemic anticoagulation, with the potential to result in haemorrhage and hemodynamic instability that can, in some instances, result in death.
Abiomed sent a letter to affected customers on 10 June regarding the potential issue. It is advised that hospitals continue to use existing inventory while closely monitoring it. And if a potential leakage from the sidearm and under the sheath cap and along the hub score lines in the hub region of these kits is observed, customers are advised to consider a device exchange and to use the kit’s repositioning sheath to minimise blood loss.
As of April 22, eight instances of major bleeding have been attributed to this issue, with three complaints corresponding to patient deaths. According to Abiomed, however, these deaths are not attributable to introducer leakage.
In response to the early alert, a J&J spokesperson said: “Impella heart pumps are life-saving devices for patients experiencing a cardiac emergency and chronic heart disease and have been used to treat more than 400,000 patients globally.
“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. 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.”
Ongoing issues with Abiomed’s Impella product range
Abiomed was acquired by Johnson & Johnson MedTech in a deal worth $16.6bn in November 2022. Since then, the company’s Impella product range has faced multiple issues that have resulted in product recalls. Impella products are catheter-based ventricular assist devices that provide temporary circulatory support for patients with failing hearts.
In April 2023, the company recalled its Impella 5.5 with SmartAssist system due to a fluid leak, a fault that could cause the system to stop pumping. In the same year, Abiomed issued a voluntary correction for six products in the Impella range due to insufficient instructions for use in patients with transcatheter aortic valve replacement (TAVR).
More recently, the FDA issued an early alert over an issue with Abiomed’s Automated Impella Controllers (AICs) used in conjunction with its Impella catheters in August 2025. One patient death was associated with the issue and resulted in Abiomed’s initiation of a voluntary recall.
Editor’s note: This article has been updated to add in commentary from J&J on the FDA’s early alert.
