ARROW IPN033056Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00801902096432), received between Dec 17, 2024 and Dec 17, 2024 — classified as 1 injury.

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

• InjuryDec 17, 2024Patient-Device Incompatibility; Connection Problem; Patient-Device Incompatibility; Connection Problem

  IT WAS REPORTED THAT AN 83-YEAR-OLD MALE PATIENT WITH CHRONIC HEMODIALYSIS WAS INITIALLY HOSPITALIZED DUE TO A SUSPECTED CATHETER IN FECTION. AFTER CATHETER REPLACEMENT, A NURSE OBSERVED THE DIALYSIS CATHETER OPEN, UNCLAMPED, WITHOUT A LUER HUB CAP, AND BLOOD ON THE FLOOR. THE NURSE CLAMPED THE LINE AND LEFT TO GRAB SOME COMPRESSES. UPON RETURNING, THE PATIENT WAS NON-REACTIVE AND COMATOSE (GCS 6). THE PATIENT SPONTANEOUSLY OPENED HIS EYES, BEING IN AND OUT OF CONSCIOUSNESS AND OCCASIONALLY RESPONSIVE TO SIMPLE QUESTIONS. THE PATIENT WAS TRANSFERRED TO THE ICU DUE TO A SUSPECTED AIR EMBOLUS CAUSED BY AN IATROGENIC INJURY TO THE RIGHT JUGULAR VEIN. A CEREBRAL CT SCAN DID NOT DETECT ANY AIR BUBBLES AT THE ENCEPHALIC LEVEL. THE PATIENT WOKE UP ON DAY 1 AFTER SEDATION WAS STOPPED, AND NAD (NICOTINAMIDE ADENINE DINUCLEOTIDE) LEVELS WERE SUBSEQUENTLY INCREASED. THE PATIENT IS CURRENTLY HOSPITALIZED FOR PNEUMOTHORAX ASSOCIATED WITH SPHERICAL BACTERIA.

  Patient problems: Coma

  MAUDE report 20953028 ↗

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-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-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