ETHICON™
4000 System
Manage tissue complexities for the most secure staple line yet
The ETHICON™ 4000 Stapler with ETHICON™ 3D Reloads feature proprietary 3D staples with offset staple legs, a strengthened and redesigned end effector, and streamlined reload options for ultimate consistency from first staple to last.1,2A
The impact of complications
Per complication3. Bariatric complications caused by thick, dense tissue and highly variable tissue can lead to bleeding.
Per leak3. Colorectal complications caused by diseased tissue or tissue that has neoadjuvant treatment can potentially cause anastomotic leaks.
Per complication3. Thoracic complications and risk of prolonged air leaks caused by complex tissue with highly variable characteristics depending on disease state and treatments.
~50% of bariatric surgeons reported they intervene to mitigate staple line bleeding.4
Introducing, the most secure staple line yet
3D Stapling Technology
Engineered for strength and stability
Expanded tissue ranges
Johnson & Johnson Launches the ETHICON™ 4000 Stapler for Elevated Surgical Experience and the Most Secure Staple Line Yet1
The stapling system features ETHICON™ 3D Reloads with proprietary 3D Stapling Technology and enhanced Gripping Surface Technology to manage tissue complexities and reduced potential leaks and bleeds at the staple line2I
New ETHICON advanced stapling technology to be harnessed for future use exclusively on the OTTAVA™ Robotic Surgical System
ETHICON 4000 Stapler and ETHICON™ 3D Reloads will be showcased at the American Society for Metabolic and Bariatric Surgery Annual Meeting on June 15-19, 2025
Johnson & Johnson MedTech, a global leader in surgical technologies and solutions, today announced the U.S. launch of the ETHICON™ 4000 Stapler, an advanced surgical stapler designed to manage tissue complexities and deliver exceptional staple line integrity to minimize risk factors for surgical leaks and bleeding complications across specialties.
With proprietary 3D Staple Technology, a redesigned end effector, and streamlined reload options for consistency from the first staple to the last to reduce potential leak pathways, the ETHICON™ 4000 and ETHICON™ 3D Reloads are approved for use in open and laparoscopic surgery today. The new advanced stapling technology and reloads are also planned for future use exclusively on the OTTAVA™ Robotic Surgical System. The company will showcase the ETHICON 4000 System alongside its comprehensive portfolio of surgical technologies at the American Society for Metabolic and Bariatric Surgery Annual Meeting taking place in Washington, DC, on June 15-19, 2025.
“We are building on a legacy of innovation and trusted performance in surgical instrumentation to offer new innovations that address some of the most common and costly surgical complications,” said Hani Abouhalka, Company Group Chairman, Surgery, Johnson & Johnson MedTech. “As surgeons work diligently to meet the changing needs of patients, surgical technology must adapt. Johnson & Johnson MedTech is responding by delivering innovation for consistent and reliable experiences across open, minimally invasive, and robotic surgery.”
A. Consistency is defined as reduced staple height variation along the staple line. This is measured by the range of average delta from nominal staple height within the functional zone (in mm): ETHICON™ 3D Reloads (0.0128 - 0.0242); Tri-Staple™ Reloads (0.0403 - 0.0720).
B. Finite element analysis found a 37% increase in staple line area for ETHICON™ 3D Reloads compared to ECHELON ENDOPATH™ Reloads with GST. Evaluation of leakage pathways. ETHICON™ 3D Reload (ER60B) had less leak pathway area at 0.302 in2 compared to ECHELON ENDOPATH™ GST Reload (GST60B) at 0.401 in2.
C. Consistency is defined as reduced staple height variation along the staple line. This is measured by the range of average delta from nominal staple height within the functional zone (in mm): ETHICON™ 3D Reloads (0.0128 - 0.0242); Tri-Staple™ Reloads (0.0403 - 0.0720).
D. The tissue range of ETHICON™ 3D Reloads is expanded compared to the ECHELON ENDOPATH™ GST Reloads.
1. Johnson & Johnson and its affiliates. Ethicon™ 4000 with Ethicon™ 3D Reloads – Staple Performance Claims. February 2024. Windchill # 502188145
2. Global Business Insights. JJMT Market & Share 4Q'24 WW Surgery. March, 2025
3. Johnson & Johnson and its affiliates. Specialty Health Economic Market Access: Focus on Complication Outcomes to Improve Patient Care. 2018.
4. Global Business Insights. Bariatric Hemostasis Segment Sizing Incidence and Key Learnings- U.S and EMEA. September, 2019
5. Johnson & Johnson and its affiliates. Evaluation of Leak Pathways for Claims: Echelon 4000 with 3D Reloads vs Echelon 3000 Stapler with GST. November 2024. Windchill # 502123426
6. Johnson & Johnson and its affiliates. Project Royal Thick Tissue Investigation. July 2024. Windchill # 502031130
For complete indications, contraindications, warnings, precautions, and adverse reactions, please reference full package insert.
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© Johnson & Johnson and its affiliates 2025. US_SRG_STAP_401680