The Recall Desk
SevereFDA (Devices)·Z-2159-2026·Announced 2026-05-20

NextStep Hemodialysis Catheters with Defective Sheath Introducer

Arrow International is recalling NextStep Antegrade and Retrograde Hemodialysis Catheters worldwide because an included 16F dual-valved splittable sheath introducer may not split as intended, potentially causing pain, bleeding, hematoma, and tissue injury.

What this means for you

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The FDA classified this as a Class I recall. Per the rubric, FDA Class I recalls are never below score 4. The hazard involves a structural/functional defect in a medical device used in an invasive procedure with risk of bleeding, tissue injury, and vessel wall injury.

Plain-English summary

Arrow International, LLC is recalling NextStep Antegrade Chronic Hemodialysis Catheters, NextStep Antegrade Hemodialysis Catheters with Arrow Simplicity Micro-Introducer, NextStep Retrograde Hemodialysis Catheters, and NextStep Retrograde Hemodialysis Catheters with Arrow Simplicity Micro-Introducer. The catheters are included in hemodialysis kits and sets that contain a 16F dual-valved splittable sheath introducer that was subject to a supplier recall.

The sheath introducer may not split as intended during use. When the device fails to split properly, patients may experience withdrawal resistance, prolonged procedure time, pain, bleeding, hematoma, tissue injury, and vessel wall injury.

The affected catheters have been distributed worldwide, including throughout the United States and to countries including Canada, the United Kingdom, Australia, Japan, Germany, France, Brazil, and many others. A total of 19,687 units are subject to this recall.

Patients currently using or prescribed these catheters should contact their healthcare provider or Arrow International for further guidance regarding their specific product.

The recalled product

Product
NextStep Antegrade Chronic Hemodialysis Catheter, REF: AC-15192-SFX, AC-15232-SFX, CS-15192-SFX, CS-15232-SFX, CS-15272-SFX, CS-15312-SFX, CS-15422-SFX, CS-15502-SFX; NextStep Antegrade Hemodialysis Catheter with Arrow Simplicity Micro-Introducer, REF: CS-15192-SFXM, CS-1523
Manufacturer
ARROW INTERNATIONAL, LLC
Category
Medical Device — Hemodialysis Catheter
Hazard
Affected units
19,687

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

  • REF/UDI-DI/Lots: AC-15192-SFX/30801902197758/AC-15192-SFX
  • AC-15232-SFX/00801902095909/33F23H1018
  • CS-15192-SFX/30801902195297/33F23E0575
  • 33F23G0530
  • 33F23K0187
  • 33F23K1104
  • 33F23L0929
  • 33F24A0275
  • 33F24C0068
  • 33F24D1012
  • 33F25C0020
  • 33F25E1083
  • 33F25G0636
  • 33F25H0292
  • 33F25H0790
  • 33F25L0038
  • CS-15232-SFX/30801902195549/33F23E0576
  • 33F23G0534
  • 33F23L0936
  • 33F24A0279

Distribution

Distributed nationwide across the United States.

The notice also names 10 states specifically:

Part of a larger recall action

This product is one of 4 recalled by ARROW INTERNATIONAL, LLC under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 4 products in this recall →

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