Dialysis Catheter Recall: Merit Medical Removes 16F Dual-Valved Splittable Sheath Introducer

Published: 04/14/2026

Sources:
  • Food and Drug Administration
Relevant To:
  • Rural Emergency Hospitals,
  • Dialysis Facilities,
  • Critical Access Hospitals,
  • Hospitals

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. 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 introducer is a component of the following kits:

  • Centros & CentrosFLO Hemodialysis Catheters
  • ProGuide Chronic Dialysis Catheters
  • 16F Dual Valved Splittable Sheath

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