Dialysis Catheter Kit Recall: Arrow International Removes Dialysis Catheter Kits Containing Merit Medical Splittable Sheath Introducers
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. The affected products and recommendations for what to do with the devices below have not changed.
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.
Reason for Recall
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
- FDA Enforcement Report
- CDRH Medical Device Recall Database
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.
Timeline of Communication Updates
| Date | Actions |
|---|---|
| 05/26/2026 | The FDA updated this communication to inform the public that this issue has been classified as a Class I Recall. |
| 04/24/2026 | The FDA issued an Early Alert communication to notify the public of a potentially high-risk device issue. |