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FDA-Device2026-04-01Class IPROCESSING DEFECT

Merit Medical ProGuide Chronic Dialysis Catheters recalled for sheath introducer design defect

Merit Medical
OTHERNationwide distribution

Stop using Merit Medical ProGuide dialysis catheters

Merit Medical Systems is recalling certain ProGuide Chronic Dialysis Catheters with a 16F dual-valved splittable sheath introducer due to a design defect. The sheath may not split as intended during insertion, which could cause serious complications including bleeding, blood clots, or damage to blood vessels.

  • Stop using affected catheters immediately if you have one with the recalled reference numbers (DC01455550/C, DC21452419/C, DC21452419-NE5/C, DC21452823-NE5/C, DC21454035/C, DC21455550/C)
  • Contact your dialysis center or healthcare provider right away to discuss your catheter and get a replacement
  • Check the lot number on your catheter packaging against the FDA recall list
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.

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
131
Manufactured in
1600 W Merit Pkwy, South Jordan, UT, United States
Products
ProGuide Chronic Dialysis Catheters, REF: DC01455550/C, DC21452419/C, DC21452419-NE5/C, DC21452823-NE5/C, DC21454035/C, DC21455550/C

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1576-2026

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