Conavi Novasight Hybrid Catheter Recall: Critical Lessons for Intravascular Device Manufacturers

Recall Overview: What Happened

Conavi Medical Inc. has voluntarily recalled its Novasight Hybrid Catheters following safety concerns identified through post-market surveillance. This recall, communicated through the FDA’s pilot program to enhance medical device recall communications, highlights critical quality control and post-market monitoring issues that all intravascular device manufacturers must address.

The Novasight Hybrid Catheter is a diagnostic intravascular imaging device used in cardiovascular procedures to provide real-time imaging guidance during interventional procedures. The recall affects all distributed units and represents a significant compliance challenge for the manufacturer.

Why This Recall Matters to Medical Device Manufacturers

Post-Market Surveillance Requirements

This recall underscores the critical importance of robust post-market surveillance systems required under 21 CFR 820.198. Intravascular devices, classified as Class II medical devices, require continuous monitoring for adverse events and device malfunctions that could impact patient safety.

Quality Management System Implications

The recall reflects potential gaps in quality management processes that manufacturers must address:

• Design Controls: Inadequate verification and validation during the design phase
• Risk Management: Insufficient identification and mitigation of foreseeable hazards per ISO 14971
• Manufacturing Controls: Potential issues with production processes and acceptance criteria

Regulatory Framework for Intravascular Device Recalls

FDA’s Enhanced Communications Pilot

This recall is part of the FDA’s Communications Pilot to Enhance the Medical Device Recall Program, which aims to improve transparency and effectiveness of recall communications. Manufacturers should expect increased scrutiny and more detailed public communications about recall actions.

Class II Device Requirements

Intravascular catheters typically fall under Class II device regulations, requiring:

• 510(k) premarket notification
• Compliance with FDA Quality System Regulation (QSR)
• Medical Device Reporting (MDR) for adverse events
• Adherence to recognized consensus standards

Critical Action Items for Manufacturers

Immediate Assessment Requirements

1. Review Your Post-Market Surveillance Program:

• Evaluate complaint handling procedures per 21 CFR 820.198
• Assess MDR reporting timeliness and accuracy
• Review trending analysis for similar device families

2. Strengthen Quality Management Systems:

• Conduct comprehensive design review of similar intravascular devices
• Verify risk management file completeness per ISO 14971
• Assess supplier controls for critical components

Long-Term Compliance Strategy

Enhanced Vigilance Systems: Implement proactive monitoring systems that go beyond minimum regulatory requirements. Consider real-world evidence collection and analysis to identify potential issues before they become recall situations.

Cross-Functional Collaboration: Ensure seamless communication between regulatory affairs, quality assurance, and clinical teams to enable rapid response to emerging safety signals.

Best Practices for Recall Prevention

Design Phase Considerations

For intravascular devices, manufacturers should implement enhanced design controls focusing on:

• Biocompatibility testing per ISO 10993 series
• Mechanical performance under physiological conditions
• Sterilization validation and package integrity
• User interface design to minimize use errors

Manufacturing Excellence

Implement statistical process control and continuous monitoring of critical manufacturing parameters. Regular validation of sterilization processes and package integrity testing are essential for intravascular devices.

Conclusion: Turning Compliance Challenges into Competitive Advantages

The Conavi Novasight Hybrid Catheter recall serves as a critical reminder that post-market surveillance is not just a regulatory requirement—it’s a business imperative. Manufacturers who invest in robust quality systems and proactive monitoring will not only avoid costly recalls but also build stronger market positions through enhanced product reliability and regulatory compliance.

Stay ahead of regulatory expectations by treating post-market surveillance as a continuous improvement opportunity rather than a compliance burden. The FDA’s enhanced communication efforts signal increased regulatory focus on transparency and manufacturer accountability in the medical device sector.