Merit Medical Removes 16F Dual-Valved Splittable Sheath Introducer

This recall involves removing certain devices from where they are used or sold. The FDA has identified this recall as the most serious type. This device may cause serious injury or death if you continue to use it.  

Affected Product

The FDA is aware that Merit Medical has issued a letter to affected customers recommending certain Dialysis catheters be removed from where they are used or sold. This introducer is a component of the following kits:

• Centros & CentrosFLO Hemodialysis Catheters
• ProGuide Chronic Dialysis Catheters
• 16F Dual Valved Splittable Sheath Introducer (bulk, non-sterile)
• DuraMax Chronic Hemodialysis Catheter
• BioFlo DuraMax Catheter

Full list of affected product lots

What to Do

Do not use Merit Medical 16F Dual-Valved Splittable Sheath Introducers.

On February 5, Merit Medical sent all affected customers a letter recommending the following actions:

• Immediately stop using the 16F Dual-Valved Splittable Sheath Introducer.
• Place the stickers provided by Merit Medical on the affected kits to ensure awareness of the recall. 
• The sheath introducer should be destroyed at point of use.
• Other products included with the sheath introducer may continue to be used.

Reason for Removal

Merit Medical is recalling the Merit 16F Dual-Valved Splittable Sheath Introducer due to a design defect where the sheath introducer may not split as intended. This sheath introducer is used in several Merit finished devices. Failure of the sheath introducer to split as intended may result in hemorrhage, foreign bodies, procedure delay, embolization/thrombosis, impaired catheter function, loss of vessel for future vascular access.

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

Device Use

The 16F Dual-Valved Splittable Sheath Introducer is a component used in several Merit finished goods and is packaged within the sterile barrier of the finished goods. The introducer is used for the delivery of the catheter into the vascular system. 

Contact Information

Customers in the U.S. with adverse reactions, quality problems, or questions about this recall should contact Merit Customer Service at RESPONSE@merit.com or 1-800-356-3748.

Additional FDA Resources

Additional Company Resources 

Company-provided information is posted here by the FDA as a public service.

Unique Device Identifier (UDI)

The unique device identifier (UDI) helps identify individual medical devices sold in the United States from distribution to use. The UDI allows for more accurate reporting, reviewing, and analyzing of adverse event reports so that devices can be identified more quickly, and as a result, problems potentially resolved more quickly.

How do I report a problem?

Health care professionals and consumers may report adverse reactions or quality problems they experienced using these devices to MedWatch: The FDA Safety Information and Adverse Event Reporting Program.

• Content current as of:

  04/14/2026

Source