ARROW IPN033026Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00801902096289), received between Aug 29, 2023 and Oct 28, 2025 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 28, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT "AFTER COMPLETION OF PROCEDURE, ON FLUSHING AND ASPIRATION OF LUMENS, LEAKAGE EXPERIENCED AT HUB ASSEMBLY, DESPITE GREEN COMPRESSION SLEEVE IN PLACE. DR REMOVED GREEN COMPRESSION SLEEVE AND REPLACE WITH THE SPARE ONE IN PACK - STILL LEAKING ON FLUSHING AND ASPIRATION AT HUB ASSEMBLY. DR REQUESTED TO OPEN A CS-15232-X 23CM SET TO ACCESS THE HUB ASSEMBLY, AS (B)(6) HOSPITAL DID NOT STOCK (B)(6) HUB REPAIR KIT. AFTER USING NEW HUB ASSEMBLY FROM NEW PACK, THE CATHETER FUNCTIONED PERFECTLY WELL ON FLUSHING AND ASPIRATION OF CATHETER LUMENS, NO LEAKAGE." THERE WAS NO PATIENT HARM OR INJURY. NO MEDICAL INTERVENTION REQUIRED. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "FINE".

  Patient problems: Insufficient Information

  MAUDE report 23401778 ↗
• MalfunctionAug 21, 2024Incomplete or Inadequate Connection; Incomplete or Inadequate Connection

  IT WAS REPORTED "DOCTOR STATES THAT THE HUB IN THE SET WOULD NOT SCREW ONTO THE CATHETER ONCE TUNNELLING WAS COMPLETED AND THEY WERE ATTACHING THE HUBS. COLLAR WAS USED." THE DEVICE WAS NOT REMOVED OR REPLACED THE CATHETER WAS LEFT IN SITU. ANOTHER HUBSET WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO MEDICAL INTERVENTION NEEDED. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "FINE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20011874 ↗
• MalfunctionFeb 9, 2024Connection Problem; Connection Problem

  IT WAS REPORTED "THE CATHETER WAS INSERTED AND WHEN DOCTOR TRIED TO CONNECT THE CATHETER USING THE SUPPLIED CONNECTOR , IT DID NOT CONNECT." ANOTHER CONNECTOR WAS USED FROM A NEW PACK AND THE SECOND ATTEMPT WAS SUCCESFUL. NO MEDICAL INTERVENTION. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "FINE."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18680016 ↗
• MalfunctionAug 29, 2023Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THE EXTENSION LINE WAS FOUND LEAKING DURING USE ON THE PATIENT. THE PATIENT'S CONDITION IS REPORTED AS FINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17645364 ↗

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-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-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