FDA-Device2026-04-01Class IPROCESSING DEFECT

Merit Medical DuraMax hemodialysis catheter recalled for sheath introducer design defect

OTHERNationwide distributionMedical devices

What this means

Merit Medical Systems is recalling certain DuraMax chronic hemodialysis catheters due to a design defect in the 16F dual-valved splittable sheath introducer. The sheath may not split properly during insertion, which could cause bleeding, blood clots, catheter malfunction, or loss of future vascular access.

Do not use affected DuraMax catheter models (REF H787103028015/A through H787103028235/A with matching lot numbers)
Contact your dialysis center or healthcare provider immediately if you have received one of these catheters
Speak with your doctor about alternative catheters before your next treatment

The agency's original wording

Hazard

16F dual-valved splittable sheath introducer due to a design defect, may not split as intended, which may result in hemorrhage, foreign bodies, procedure delay, embolization/thrombosis, impaired catheter function, loss of vessel for future vascular access.

Intended for

Adults

Illnesses reported

None reported

Sold states

Worldwide distribution: US (nationwide) to states of: 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 and OUS (International) to countries of : Canada, Spain, United Arab Emirates, Brazil, Jordan, Iraq, France, Indonesia, Malaysia, Thailand, Slovakia, Colombia, Saudi Arabia, Belize, Hong Kong, Mexico, Austria, Belgium, Chile, Germany, Sweden, Ireland, Poland, Latvia, Italy, South Africa, Switzerland, Bulgaria, Peru, Argentina, Qatar, Greece, Georgia, United Kingdom, Brunei Darussalam, Ecuador, Panama, Netherlands, Venezuela, Bolivarian Republic of, Costa Rica, Viet Nam, Cayman Islands, Iran, Islamic Republic of, Australia, Nicaragua, Dominican Republic, Bolivia, Plurinational State of, El Salvador, Guatemala, Honduras, Japan

Affected count

21,591

Manufactured in

1600 W Merit Pkwy, South Jordan, UT, United States

Products

DuraMax Chronic Hemodialysis Catheter, REF: 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

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1578-2026

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