What product is recalled?

The DuraMax chronic hemodialysis catheter with REF numbers H787103028015/A through H787103028235/A, containing a 16F dual-valved splittable sheath introducer.

The 16F dual-valved splittable sheath introducer may not split as intended, increasing risk of hemorrhage and retained foreign bodies.

Are there injuries reported?

No injuries or incidents have been reported at this time.

What should I do if I own this device?

Stop using the device immediately and contact Merit Medical Systems or your clinician for instructions. Follow the recall notice for refunds or replacements.

Where can I find the REF numbers and other identifiers?

REF numbers appear on device labels and packaging. Model numbers and UDI/Lot codes may also be listed in the recall documentation.

Who should be contacted for recall support?

Merit Medical Systems or your healthcare provider. The recall page is hosted by the FDA with details and next steps.

Will I receive a refund or replacement?

Merit Medical Systems typically offers refunds or replacements as part of the recall process. Follow the manufacturer instructions.

Is this recall limited to the United States?

Distribution is worldwide, including all U.S. states and multiple international countries.

What about devices already implanted?

Clinicians should assess on a case-by-case basis. Contact the manufacturer for guidance on implanted devices involved in the recall.

How long does the recall process take?

Refunds or replacements are typically processed within several weeks, depending on inventory and logistics.

HIGHFebruary 13, 2026

Merit Medical's DuraMax 16F Hemodialysis Catheter Recalled For Splittable Sheath Defect (2026)

Merit Medical Systems recalled 21,591 DuraMax chronic hemodialysis catheters worldwide. The devices use a 16F dual-valved splittable sheath introducer that may not split as intended, risking hemorrhage and procedure delays. Clinicians should stop using the devices immediately and follow the recall instructions.

Quick Facts at a Glance

Recall Date: February 13, 2026
Hazard Level: HIGH
Brand: Merit Medical Systems
Category: Health & Personal Care
Sold At: Multiple Retailers
Geographic Scope: 1 states
At-Risk Groups: GENERAL

Hazard Information

16F dual-valved splittable sheath introducer due to a design defect, may not split as intended, which may result in hemorrhage, foreign bodies, and procedure delay.

What You Should Do

Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Merit Medical Systems, Inc. or your healthcare provider for instructions

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About This Product

The DuraMax Chronic Hemodialysis Catheter is a long-term vascular access device used in dialysis. It includes a 16F sheath introducer that may be splittable for catheter placement.

Why This Is Dangerous

If the sheath does not split as designed, it can cause hemorrhage, leave foreign material in the patient, or delay a dialysis procedure.

Industry Context

This recall is not presented as part of a broader industry pattern in the available data.

Real-World Impact

Clinicians and patients may face procedure delays and potential surgical complications. A prompt stop-use and recall follow-through are essential.

Practical Guidance

How to identify if yours is affected

Review REF numbers on the device label: H787103028015/A, H787103028025/A, H787103028031/A, H787103028035/A, H787103028041/A, H787103028045/A, H787103028051/A, H787103028055/A, H787103028061/A, H787103028075/A, H787103028085/A, H787103028095/A, H787103028165/A, H787103028181/A, H787103028185/A, H787103028191/A, H787103028195/A, H787103028205/A, H787103028215/A, H787103028225/A, H787103028235/A.
Check if the REF matches any listed in the recall notice
Inspect packaging for the device type: DuraMax 16F chronic hemodialysis catheter with dual-valved sheath introducer

Where to find product info

On device labels, packaging, hospital procurement documents, and the FDA recall page linked in the notice.

What timeline to expect

Refunds or replacements typically complete within 4-8 weeks after qualification and authorization.

If the manufacturer is unresponsive

Escalate to hospital infection control or medical device compliance team
File a complaint with the FDA recall program if applicable
Document all communications and responses

How to prevent similar issues

Verify recalls before stocking devices for dialysis access
Require updated lot/UDI documentation in purchasing
Use approved vendor catalogs and current recalls checklists

Documentation advice

Keep photos of the device label, packaging, and recall notice. Save correspondence with Merit Medical and hospital procurement.

Product Details

REF numbers: H787103028015/A, H787103028025/A, H787103028031/A, H787103028035/A, H787103028041/A, H787103028045/A, H787103028051/A, H787103028055/A, H787103028061/A, H787103028075/A, H787103028085/A, H787103028095/A, H787103028165/A, H787103028181/A, H787103028185/A, H787103028191/A, H787103028195/A, H787103028205/A, H787103028215/A, H787103028225/A, H787103028235/A. Distribution: Worldwide. United States states listed include TX, LA, OR, NM, MI, FL, CO, CA, GA, NC, AK, NY, PA, WI, NJ, VA, AZ, IN, KY, MO, DE, SC, MT, NE, WV, OH, MA, MN, CT, MD, KS, WA, TN, ID, UT, DC, MS, IL, OK, AL, RI, AR,NV

Reported Incidents

No injuries or incidents have been reported.

Key Facts

21,591 units recalled worldwide
Device uses a 16F dual-valved splittable sheath introducer
Defect may prevent splitting as intended, risking hemorrhage and foreign bodies
No injuries or incidents have been reported to date
Recall includes numerous REF numbers and worldwide distribution including all US states
FDA recall number Z-1578-2026

View Original Recall on FDA - Medical Devices

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Safety Assessment

Risk LevelHIGH

Severity Score

8/ 10

Affected Groups

GENERAL

Injury Types

OTHER

Product Classification

CategoryHealth & Personal Care › Medical Devices

Product Type16F dual-valved splittable sheath introducer

Product Details

Dec 4, 2025

Merit Medical Systems

Inflation device