ARROW IPN033055Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00801902043931), received between Jul 15, 2021 and Jul 15, 2021 — classified as 1 malfunction.

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

4 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.

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.

• MalfunctionJul 15, 2021Material Rupture; Material Rupture

  IT WAS REPORTED THAT: "A 66-YEAR-OLD FEMALE PATIENT WITH A RIGHT INTERNAL JUGULAR TUNNEL CATHETER INSERTED SINCE (B)(6) 2019 [HAD] A CT ANGIOGRAM PERFORMED ON (B)(6) 2021. A HEMODIALYSIS CATHETER WAS NECESSARY TO INJECT A CONTRAST PRODUCT. THE CONTRAST PRODUCT WAS INJECTED USING AN AUTOMATIC INJECTOR (200 PSI) ON THE RED LINE WITHOUT UNCLAMPING THE CLAMP OF THE CATHETER. THE DEGRADATION OF THE EXTENSION LINE OF THE CENTRAL VENOUS HEMODIALYSIS CATHETER REQUIRED ITS CHANGE". NO INJURY OR CONSEQUENCE REPORTED. PATIENT CONDITION REPORTED AS "FINE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12177688 ↗

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-2158-2026 · Apr 10, 2026 · Open, Classified
  Cannon II Plus Hemodialysis Catheter, REF: CS-15242-VSP, CS-15282-VSP, CS-15322-VSP, CS-15362-VSP, CS-15552-VSP, CSD-15242-SP, CSD-15282-SP; Cannon II Plus Hemodialysis Catheter w
• 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