Arrow recalls specific NextStep hemodialysis catheters due to a sheath introducer that may not split properly, leading to pain, bleeding, or tissue injury during dialysis procedures.
16F dual-valved splittable sheath introducer, the subject of a supplier recall, was included in impacted hemodialysis kits & sets. Sheath introducer may not split as intended, and may result in withdrawal resistance, prolonged procedure time, pain, bleeding, hematoma, tissue injury, vessel wall injury.
Arrow is recalling certain NextStep hemodialysis catheters because a component called a sheath introducer might not split as intended. This could cause pain, bleeding, hematoma, or tissue injury during dialysis treatments.
The 16F dual-valved splittable sheath introducer included in the catheters may not split correctly during use. This can cause increased resistance when withdrawing fluid, longer procedure times, pain, bleeding, hematoma formation, or tissue/vessel wall injury.
Patients receiving hemodialysis treatments using the recalled catheters are most at risk. Healthcare providers who use these catheters in medical settings may also be affected.
Check for model numbers starting with AC-15192-SFX, AC-15232-SFX, CS-15192-SFX, CS-15232-SFX, or similar codes listed in the recall notice. The catheters are used in hemodialysis treatments and were sold with specific lot numbers.
Identify the model number on the catheter packaging or label to confirm if it is in the recalled list.
If you use the catheter for hemodialysis, contact your healthcare provider to discuss whether the catheter needs replacement.
The 16F dual-valved splittable sheath introducer may not split as intended, which can cause withdrawal resistance, prolonged procedure time, pain, bleeding, hematoma, or tissue injury during dialysis.
No, but you should check if your catheter is in the recalled list and contact your healthcare provider for guidance.
Contact your healthcare provider to discuss whether the catheter needs replacement. The recall does not include a specific return or replacement process.
We’ve drafted a message you can send Arrow to request your refund or repair — edit it as you like.
Subject: Recall Z-2159-2026 — Arrow Arrow Hello, I own a Arrow that is covered by recall Z-2159-2026 from Arrow. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
