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 notification. On February 27, a supplemental notice was sent, and on March 23 a revision notice was sent to all affected customers. These notifications recommend 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. Note that the introducer is sealed within the sterile barrier and cannot be removed or destroyed at the inventory level. Opening the unit packaging would compromise the sterility of the remaining components and therefore should occur at the 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.
- Merit Medical Recall Letter 02/05/2026
- Merit Medical Recall Web Page 02/05/2026
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 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.