ARROW IPN033038Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00801902096340), received between Dec 2, 2024 and Dec 2, 2024 — classified as 1 malfunction.

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

2 other recalls cover devices cleared under the same FDA submission (K111900); 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.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 2, 2024Material Separation; Material Separation

  IT WAS REPORTED "THE WINGS OF PEAL-AWAY INTRODUCER VALVE BODY DID NOT PEELED AWAY PROPERLY AFTER CATHETER INSERTION." ADDITIONAL INFORMATION RECEIVED REPORTS "THE WINGS BROKE OFF CORRECTLY BUT I HAD TO REALLY FORCE THEM TO PEEL OFF THE INTRODUCER." THERE WAS NO PATIENT CONSEQUENCES. NO MEDICAL INTERVENTION REQUIRED. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "FINE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20824951 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K111900. 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-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