FDA Recall Notification

Merit Medical Removes 16F Dual-Valved Splittable Sheath Introducer

Design Defect May Lead to Hemorrhage, Embolization, and Loss of Vascular Access

The U.S. Food and Drug Administration (FDA) has identified a Class I recall involving Merit Medical’s 16F Dual-Valved Splittable Sheath Introducer, a component used in multiple dialysis catheter systems. A Class I recall is the FDA’s most serious classification and indicates that continued use of the device may cause serious injury or death.

Affected Products

The recalled sheath introducer, used in vascular access procedures for hemodialysis patients is included in the following systems:

Centros & CentrosFLO Hemodialysis Catheters

ProGuide Chronic Dialysis Catheters

DuraMax Chronic Hemodialysis Catheter

BioFlo DuraMax Catheter

16F Dual-Valved Splittable Sheath Introducer (bulk, non-sterile)

Reason for Recall

Merit Medical initiated the recall due to a design defect in which the sheath introducer may fail to split as intended during catheter placement. This failure can compromise the procedure and create significant clinical risk.

Potential Risks

Failure of the sheath introducer may result in hemorrhage, retained foreign body, procedure delay, embolization or thrombosis, impaired catheter function, or loss of vessel for future vascular access. These complications are particularly serious in dialysis patients, where vascular access is critical and often limited.

Reported Events

As of February 23, Merit Medical has reported two serious injuries and no deaths.

Device Use

The 16F Dual-Valved Splittable Sheath Introducer, which is packaged within dialysis catheter kits, is used to introduce the catheter into the vascular system. It is designed to split and be removed after catheter placement. Failure of the device to split properly directly impacts procedural safety and outcomes.

What Healthcare Providers Should Do

Merit Medical has instructed customers to immediately stop using the 16F Dual-Valved Splittable Sheath Introducer, apply recall notification stickers to affected kits, and destroy the sheath introducer at the point of use. Customers may continue using other components in the kits, if appropriate.

MDP Analysis

Design Failure in a Critical Procedural Component

This recall highlights a key regulatory and quality concern, that the failure of a seemingly simple mechanical function can have high clinical consequences. The sheath introducer plays a critical role in vascular access procedures, and its failure introduces multiple layers of risk, including procedural complications, patient safety impact, and long-term treatment limitations.

Regulatory and Quality Considerations

This event raises important questions regarding design validation for device functionality under clinical conditions, human factors and usability in high-risk procedures, verification of mechanical performance under real-world use scenarios, and supplier and component-level risk management.

For manufacturers, this underscores the importance of robust design controls, comprehensive verification and validation, and risk-based evaluation of component failure modes.

Broader Industry Insight

In complex medical systems, component-level failures can drive system-level risk. Even when the primary device (e.g., catheter) is functioning as intended, failure of a supporting component can compromise the entire procedure, increase patient risk, and trigger regulatory action.

Merit Medical Contact Information

Healthcare providers with questions or adverse event reports should contact Merit Medical Customer Service by phone at 1-800-356-3748, or email at response@merit.com.

MDP Perspective

This recall illustrates a fundamental principle. Device safety depends on the reliability of every component, not just the primary system. For manufacturers, it reinforces the need for integrated risk management, end-to-end system validation, and vigilant postmarket surveillance.

Contact Us

Do you need support evaluating design controls, risk management, or recall response strategies? MDP provides expert guidance in quality systems, regulatory compliance, and postmarket risk mitigation. Contact us today.

Links

Merit Medical recall page

Read the FDA’s announcement here.