ARROW IPN033104Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 20801902096610), received between Jan 26, 2026 and Apr 8, 2026 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Crack” (1 report).

1 FDA recall record name this device's identifier, 1 still open.

3 other recalls cover devices cleared under the same FDA submission (K111117); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

1. Apr 10, 2026Open, Classified

   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.

   Z-2158-2026 · Root cause: Nonconforming Material/Component · FDA record ↗

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 8, 2026Material Separation

  IT WAS REPORTED THAT: "THE HUB CONNECTION SEPARATED FROM THE ASSEMBLY WHEN DR. W. WAS ATTEMPTING TO PLACE THE CATHETER. THE HUB ASSEMBLY FELL ON THE FLOOR, SO WE HAD TO OPEN ANOTHER CATHETER KIT. THE WAS NOT ON THE PATIENT YET. IT WAS AFTER OPENING THE KIT. THE PACKAGING WAS NOT DAMAGED. NO HARM CAME TO THE PATIENT. WE HAD TO OPEN ANOTHER CATHETER KIT. THE PATIENT IS STABLE AND HAS BEEN COMING TO DIALYSIS."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24814136 ↗
• MalfunctionJan 26, 2026Crack

  IT WAS REPORTED THAT: " THE PATIENT JUST STARTED DIALYSIS TREATMENT AND THE ARTERIAL HUB BROKE, WHEN CAP CAME OFF THE DAMAGE WAS SEEN. NO AIR OR PARTICULATE ENTERED THE PATIENT. THE ARTERIAL HUB WAS BEING CLEANED AFTER REMOVING THE CAP. THE PATIENT WAS NOT HOOKED UP TO THE DIALYSIS MACHINE. NO INJURIES OCCURRED. THE ISSUE WAS RESOLVED BY CHANGING OUT THE CATHETER FOR A NEW ONE. THE MEDICAL INTERVENTION WAS A CATHETER EXCHANGE."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24176229 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K111117. One submission often covers many models, so check the product and lot details in each record.

• Z-2156-2026 · Apr 10, 2026 · Open, Classified
  Arrow Edge Hemodialysis Catheterization Product, REF: CS-15242-I, CS-15282-I, CS-15322-I
• Z-2159-2026 · Apr 10, 2026 · Open, Classified
  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 A
• Z-1007-2015 · Feb 4, 2013 · Terminated
  The Arrow Edge Hemodialysis Catheterization Set Long-Term Access and NextStep Antegrade Hemodialysis Catheterization Set, Long-Term Access, part numbers: AC-15192-SFX, AC-15232-SFX