FDA Early Alert: Arrow International Removes Dialysis Catheter Kits Containing Merit Medical Splittable Sheath Introducers

Published: 04/24/2026

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

Arrow International has initiated an urgent Medical Device Recall notification for kits that contain hemodialysis catheters affected by a previous recall of Merit Medical’s 16F Dual-Valved Splittable Sheath Introducers.

See Full list of affected product lots

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 sheath introducer is used in several impacted Arrow Hemodialysis Kits …

Sign Up for Free Trial