Olympus Recalls ViziShot 2 FLEX EBUS-TBNA Needles: Critical Component Detachment Risk

Understanding the Olympus ViziShot 2 FLEX Recall

On September 19, 2025, Olympus Corporation initiated a voluntary global recall of its ViziShot 2 FLEX (19G) EBUS-TBNA needles manufactured before May 12, 2025. This recall highlights critical safety concerns that every medical device manufacturer must understand and prepare for in their own operations.

What Happened: Component Detachment During Procedures

The recall was triggered by reports of device components detaching during endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA) procedures. This type of failure represents one of the most serious complications in minimally invasive medical devices – leaving foreign material inside patients during diagnostic procedures.

Component detachment during EBUS-TBNA procedures can result in:

• Retained foreign objects requiring additional surgical intervention
• Extended procedure times and patient exposure to anesthesia
• Potential tissue damage or infection
• Compromised diagnostic sample quality

Regulatory Context: FDA’s Response to Device Component Failures

The FDA classifies component detachment as a serious adverse event that can lead to patient harm. Under 21 CFR 806, manufacturers must report such incidents within 24 hours if they could cause serious injury or death. Olympus’s voluntary recall demonstrates proactive compliance with FDA expectations for manufacturer responsibility.

This recall falls under FDA’s Class II recall category, indicating a situation where use of the device may cause temporary or medically reversible adverse health consequences, but where the probability of serious adverse health consequences is remote.

Manufacturing Date Significance: Quality Control Timeline

The recall specifically targets devices manufactured before May 12, 2025, suggesting Olympus identified and corrected a manufacturing process issue around that timeframe. This timeline approach is common in medical device recalls when manufacturers can pinpoint when corrective actions were implemented in their production systems.

Critical Lessons for Medical Device Manufacturers

Post-Market Surveillance Requirements

This recall underscores the importance of robust post-market surveillance systems required under ISO 13485 and FDA regulations. Medical device manufacturers must:

• Establish systematic complaint handling procedures
• Monitor field performance through multiple channels
• Analyze trends that could indicate systematic issues
• Maintain traceability to specific manufacturing lots

Component Attachment Risk Management

For manufacturers of complex assembly devices, this recall highlights critical risk management considerations under ISO 14971:

• Design Controls: Implement robust attachment mechanisms with appropriate safety factors
• Process Validation: Ensure assembly processes consistently achieve required bond strengths
• Testing Protocols: Develop fatigue testing that simulates real-world use conditions
• Supplier Management: Qualify component suppliers and materials thoroughly

Immediate Action Items for Compliance Teams

Review Your Own Devices

Evaluate whether your devices have similar component attachment risks. Consider:

• Reviewing FMEA documentation for attachment failure modes
• Assessing current post-market surveillance data
• Updating risk management files if necessary

Strengthen Surveillance Systems

Use this recall as a case study to enhance your post-market surveillance capabilities:

• Train customer-facing teams to recognize and report component issues
• Establish direct communication channels with key clinical users
• Implement proactive monitoring for similar failure patterns

Prepare Recall Procedures

Ensure your recall procedures under 21 CFR 7 are current and tested:

• Verify customer contact databases are updated
• Review recall communication templates
• Confirm lot traceability systems are functioning

Conclusion: Proactive Quality Management

The Olympus ViziShot 2 FLEX recall demonstrates how even established manufacturers can face unexpected component performance issues. The key differentiator is having systems in place to detect, assess, and respond to these issues quickly and effectively.

Medical device manufacturers should view this recall not as an isolated incident, but as a reminder of the continuous vigilance required in post-market surveillance and quality management. By learning from industry examples like this one, manufacturers can strengthen their own compliance posture and better protect both patients and their businesses.