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FDA-Device2026-04-01Class IPROCESSING DEFECT

Merit Medical Systems 16F splittable sheath introducer recalled for design defect causing failure to split

Merit Medical
OTHERNationwide distribution

Stop using Merit Medical 16F sheath introducer

Merit Medical Systems is recalling specific lots of its 16F dual-valved splittable sheath introducer because of a design defect that may prevent it from splitting properly during use. This could lead to serious complications including bleeding, blood clots, or damage to blood vessels.

  • If you have received this device, stop using the affected lot numbers immediately
  • Contact Merit Medical Systems or your supplier for instructions on returning or destroying the product
  • Check the device lot number against the recall list to confirm if your stock is affected
  • Notify your facility's quality or materials management team of this recall
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
368,264
Manufactured in
1600 W Merit Pkwy, South Jordan, UT, United States
Products
16F Dual Valved Splittable Sheath Introducer (bulk, non-sterile), REF: FCL-174-00/B

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1577-2026

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