Arrow International Removes Dialysis Catheter Kits Containing Merit Medical Sheath Introducer

CDRH is issuing this Early Alert **to notify the public of a potentially high-risk device issue.* The FDA will keep the public informed and update this web page as significant new information becomes available.*

Affected Product

The FDA is aware that Arrow International has issued a letter to affected customers recommending dialysis catheter kits containing Merit Medical 16F Dual-Valved Splittable Sheath Introducers be removed from where they are used or sold.

Affected products:

• Arrow Edge Hemodialysis Catheterization Product
• Arrow-Clark VectorFlow Antegrade Chronic Hemodialysis Catheter
• Arrow-Clark VectorFlow Retrograde Chronic Hemodialysis Catheter
• Cannon II Plus Chronic Hemodialysis Catheter
• NextStep Antegrade Chronic Hemodialysis Catheter
• NextStep Retrograde Chronic Hemodialysis Catheter Full list of affected product lots

What to Do

Do not use Merit Medical 16F Dual-Valved Splittable Sheath Introducers in the Arrow International kits and sets.

In April, Arrow International sent all affected customers a letter recommending the following actions:

• Immediately stop use and distribution of the affected kits and sets.
• Return affected kits and sets to Arrow International. Check this web page for updates. The FDA is currently reviewing information about this potentially high-risk device issue and will keep the public informed as significant new information becomes available.

Reason for Alert

Arrow International initiated an urgent Medical Device Recall notification for kits that contain hemodialysis catheters affected by Merit Medical’s Dialysis Catheter Recall: Merit Medical Removes 16F Dual-Valved Splittable Sheath Introducer.

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 impacted Arrow Hemodialysis Kits and Sets. 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. As of April 21, Arrow International has not reported any additional patient injuries or deaths.

Device Use

The 16F Dual-Valved Splittable Sheath Introducer is a component used in several Arrow Hemodialysis kits and sets 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 Teleflex Customer Service at Recalls@teleflex.com or 1-866-396-2111.

Additional FDA Resources

• Dialysis Catheter Recall: Merit Medical Removes 16F Dual-Valved Splittable Sheath Introducer [04/14/2026]
• FDA Enforcement Report for Merit Medical 16F Dual-Valved Splittable Sheath Introducer recall
• CDRH Medical Device Recall Database for Merit Medical 16F Dual-Valved Splittable Sheath Introducer recall

Unique Device Identifier (UDI)

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

• How do I recognize a UDI on a label?
• AccessGUDID database - Identify Your Medical Device
• Benefits of a UDI System

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:

04/24/2026

• Regulated Product(s)

  • Medical Devices