ARROW IPN055260Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 30801902155956), received between Jan 9, 2022 and Oct 14, 2022 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Air/Gas in Device” (2 reports).

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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 14, 2022Air/Gas in Device; Air/Gas in Device

  IT WAS REPORTED THAT: THE CATHETER WAS INSERTED BY THE VASCULAR SURGEONS ON (B)(6) 2022. SINCE (B)(6) 2022, THE PATIENT HAD HEMODIALYSIS SESSIONS WITH THIS CATHETER. ON (B)(6) 2022, THE HEMODIALYSIS MACHINE (ALARM) RANG AND STOPPED DUE TO THE PRESENCE OF AN AIR BUBBLE DETECTED IN THE CATHETER. IT WAS OBSERVED BY THE NURSING TEAM. THIS LED TO A RE-HOSPITALIZATION AND PROLONGED HOSPITALIZATION ON (B)(6) 2022, THE REMOVAL OF THE INITIAL CATHETER AND THE INSERTION OF A NEW CATHETER. ADDITIONAL INFORMATION RECEIVED ON 14OCT2022: THE CATHETER WAS INSERTED FOR CHRONIC HEMODIALYSIS ON (B)(6) 2022. THE PATIENT HAD A FIRST HEMODIALYSIS SESSION IN INTENSIVE CARE ON (B)(6) 2022 WITH SUCCESS. PATIENT COMES 3 TIMES A WEEK TO THE HOSPITAL FOR HEMODIALYSIS SESSIONS. ON 17AUG2022, THE ALARM RANG , AND THE MACHINE STOPPED AS IT DETECTED AIR. ON (B)(6) 2022, THE PATIENT HAD AN INTERVENTION AT THE CLINIC. THE CATHETER INSERTED IN THE FIRST HOSPITAL IN RIGHT JUGULAR WAS REMOVED A NEW ONE INSERTED IN LEFT JUGULAR. THERE WERE NO CONSEQUENCES FOR THE PATIENT BECAUSE THE MACHINE STOPS WHEN IT DETECTS AIR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15608975 ↗
• MalfunctionFeb 14, 2022Air/Gas in Device; Air/Gas in Device

  IT WAS REPORTED AIR ENTERED THE DIALYSIS CIRCUIT. THE "FIXATION RING (LUER HUB) WAS NOT POSITIONED CORRECTLY AND THUS WAS NOT PROPERLY PROVIDING THE SEAL (LEAK)". THE LUER HUB AND RING WERE REPLACED. NO PATIENT HARM WAS REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 13529261 ↗
• MalfunctionJan 9, 2022Break; Break

  IT WAS REPORTED THAT: "INCIDENT HAPPENED ON (B)(6) 2021. THE TIGHTENING RING BROKE IN HALF (DESPITE BEING SCREWED AS USUAL). DURING THE SESSION, THE CIRCUIT FILLED WITH AIR AND A VERY LARGE HEMATOMA FORMED IN THE SUBCUTANEOUS TUNNEL." IT WAS REPORTED THE PATIENT IS FINE AND THE HEMATOMA IS FADING AWAY. THE DEVICE WAS REMOVED.

  Patient problems: Hematoma

  MAUDE report 13201050 ↗

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-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-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