ARROW IPN920480Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 20801902195184), received between Dec 15, 2022 and Jul 6, 2026 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Disconnection” (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.

• MalfunctionJul 6, 2026Fluid/Blood Leak; Material Split, Cut or Torn

  IT WAS REPORTED THAT, DURING BLOOD ASPIRATION PRIOR TO CONNECTION TO THE HEMODIALYSIS MACHINE, BLOOD WAS OBSERVED OOZING FROM A SLIT APPROXIMATELY 0.1 CM IN LENGTH IN THE CHRONIC HEMODIALYSIS CATHETER (CHDC) BELOW THE EXIT SITE. AS A RESULT, TREATMENT WAS DELAYED. THERE WERE NO REPORTS OF PATIENT INJURY, HARM, OR ADVERSE HEALTH CONSEQUENCES ASSOCIATED WITH THIS EVENT OTHER THAN A DELAY IN THERAPY. THE PATIENT'S CONDITION WAS REPORTED AS FINE. THE AFFECTED DEVICE WAS REMOVED FROM USE AND WAS PENDING REPLACEMENT AT A FUTURE DATE. NO ADDITIONAL MEDICAL INTERVENTION WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25727568 ↗
• MalfunctionDec 15, 2022Disconnection; Disconnection

  THE COMPLAINT IS REPORTED AS: DURING A DIALYSIS LINE PLACEMENT THE SCRUB NURSE AND INTERVENTIONAL RADIOLOGIST EXPERIENCED DIFFICULTY FLUSHING THE DIALYSIS LINE PRIOR TO TUNNELLING. WHEN PREPPING THE LINE, THE IRRIGATION TUBE WITH CLAMP DISCONNECTED FROM THE LINE WHEN FLUSHING. THE HAPPENED SEVERAL TIMES. THE LINE FROM KIT WAS LEFT IN SITU IN THE PATIENT AS IT WAS FUNCTIONING CORRECTLY. IT WAS FURTHER CLARIFIED ON PREPARATION OF THE LINE, THE TEMPORARY IRRIGATION TUBE WITH CLAMP DETACHED FROM THE LINE WHEN BEING FLUSHED WITH SALINE. A HUB FROM ANOTHER KIT WAS USED. IT WAS REPORTED THERE WAS NO ADVERSE EFFECTS OR HARM TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15986651 ↗

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-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-2156-2026 · Apr 10, 2026 · Open, Classified
  Arrow Edge Hemodialysis Catheterization Product, REF: CS-15242-I, CS-15282-I, CS-15322-I
• 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