ARROW IPN033030Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 00801902096302), received between Jul 13, 2023 and Dec 4, 2025 — classified as 11 malfunctions.

The most frequently reported specific device problem is “Crack” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 4, 2025Break; Break

  IT WAS REPORTED THAT: INCIDENT OCCURED ON (B)(6) 2025. THERE WAS A FAILURE OF THE GREEN RING AT THE LEVEL OF THE "Y". THE BREAK OCCURRED WHEN THE DEVICE WAS FIRST INSERTED AND IT WAS IMMEDIATELY REPLACED WITH A SECOND CATHETER.

  Patient problems: Insufficient Information

  MAUDE report 23713931 ↗
• MalfunctionMay 9, 2025Material Separation; Failure to Advance; Material Separation; Failure to Advance

  IT WAS REPORTED "DOCTOR STATES DILATOR CAP CAME OFF. SHE COULD NOT ADVANCE SHEATH." THE USER CHANGED TO A NEW SET. THERE WAS NO PATIENT HARM OR INJURY. NO MEDICAL INTERVENTION REQUIRED. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "FINE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21993330 ↗
• MalfunctionApr 9, 2025Material Disintegration; Material Disintegration

  IT WAS REPORTED THAT "GREEN SILICONE JOINT WAS NON-PERMEABLE. DEVICE WAS CHANGED. " ADDITIONAL INFORMATION RECEIVED REPORTS "WHEN THE SEAL WAS INSERTED, THE DEVICE DISINTEGRATED IN A CIRCULAR FASHION". THERE WAS NO CLINICAL CONSEQUENCES FOR THE PATIENT. NO MEDICAL INTERVENTION REQUIRED. THE PATIENT'S CURRENT CONDITION IS REPORTED AS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21806988 ↗
• MalfunctionMar 6, 2025Crack; Crack

  IT WAS REPORTED THAT "WHILE PREPARING THE CONNECTION, THE NURSE NOTICED A MASSIVE SALINE LEAK WHEN CHECKING THE SEAL OF THE ARTERIAL BRANCH OF THE CATHETER, ALONG WITH A CONSEQUENT CRACK. THE DOCTOR WAS CALLED, AND THE DIALYSIS SESSION WAS PERFORMED USING A SINGLE PUNCTURE ON THE VENOUS BRANCH. THE CATHETER WAS REPLACED AT ANOTHER SITE". ADDITIONAL INFORMATION INDICATED THAT THERE WAS A TEMPORARY REDUCTION OF DIALYSIS QUALITY, THE PATIENT WAS REPORTED TO BE 'FINE'.

  Patient problems: Anxiety

  MAUDE report 21535539 ↗
• MalfunctionNov 7, 2024Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED "LAST WEEK, THE DIALYSIS DEPARTMENT ENCOUNTERED AN INCIDENT INVOLVING A NEXTSTEP HAEMODIALYSIS CATHETER, WHERE AIR WAS ASPIRATED ON THE EXTENSION LINE." THE DEVICE WAS REMOVED AND REPLACED. THERE WAS NO PATIENT HARM OR INJURY. NO MEDICAL INTERVENTION REQUIRED. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "FINE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20630758 ↗
• MalfunctionJul 2, 2024Fluid/Blood Leak; Loose or Intermittent Connection; Material Separation; Fluid/Blood Leak; Loose or Intermittent Connection; Material Separation

  IT WAS REPORTED THAT: "A LEAK WAS OBSERVED ON THE REPLACEABLE HUB CONNECTOR AND THE FIXATION RING AT THE END OF INSERTION AFTER THE CONNECTING THE 2 PARTS. THE USER REPORTED THAT IT WAS IMPOSSIBLE TO FULLY CONNECT THE 2 PARTS. THEREFORE , THE USER HAD TO USE A REPLACEMENT KIT TO FINISH THE PROCEDURE, CAUSING DELAY. NO OTHER PROBLEM REPORTED. ".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19653574 ↗
• MalfunctionMay 20, 2024Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT "UPON INSERTION OF THE CATHETER THERE WERE NO ISSUES EXPERIENCED AND CATHETER WAS FLUSHED AND CLAMPED HOWEVER POST INSERTION PRIOR TO APPLYING DRESSING, IT WAS NOTICED THAT THE CATHETER / HUB WAS 'CUT'. THE DEVICE WAS REMOVED ENTIRELY AND REPLACED WITH ANOTHER SET SUCCESSFULLY. NO DELAY IN TREATMENT. NO PATIENT COMPLICATIONS OR INJURY. NO MEDICAL INTERVENTION".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19352880 ↗
• MalfunctionMay 20, 2024Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED "A MICRO AIR BUBBLE WAS OBSERVED ON THE DIALYSIS CIRCUIT. MICRO HOLE IN THE ARTERIAL LINE OF THE CATHETER. NO DIALYSIS DONE ON THAT DAY AND RESCHEDULED FOR THE 15TH JANUARY WITH THE REPLACEMENT OF PART OF THE DEVICE."

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 19350413 ↗
• MalfunctionFeb 2, 2024Material Deformation; Material Deformation

  IT WAS REPORTED "THE SCREW THREAD WAS DEFECTIVE AND THE DILATOR'S NON-RETURN VALVE WAS DYSFUNCTIONAL". THE CURRENT CONDITION OF THE PATIENT IS "UNKNOWN". AT THE TIME OF THIS REPORT, THE CUSTOMER HAS NOT RETURNED OUR REQUESTS FOR ADDITIONAL INFORMATION. IF FURTHER INFORMATION IS RECEIVED, THE COMPLAINT FILE WILL BE UPDATED. ASSOCIATED MDR NUMBER: 9680794-2024-00049

  Patient problems: Insufficient Information

  MAUDE report 18629618 ↗
• MalfunctionFeb 2, 2024Material Deformation; Material Deformation

  IT WAS REPORTED THAT " SURGEON DR BONNIN HAD A DEFECTIVE DEVICE. 2 DIFFERENT FAILURES: - THE SCREW THREAD WAS DEFECTIVE - THE DILATOR'S NON-RETURN VALVE WAS DYSFUNCTIONAL (THIS COMPLAINT) SO DR BONNIN HAD TO USE ANOTHER CATHETER FOR THE PROCEDURE." ASSOCIATED COMPLAINTS (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 18629589 ↗
• MalfunctionJul 13, 2023Crack; Fluid/Blood Leak; Crack; Fluid/Blood Leak

  IT WAS REPORTED THE CATHETER WAS INSERTED ON (B)(6) 2023 AND ON (B)(6) 2023 THE PATIENT WAS ADMITTED FOR DIALYSIS AND THE NURSES STATE THE RED HUB IS CRACKED AND LEAKING. NO PATIENT HARM WAS REPORTED. A HUB REPAIR KIT WAS USED TO REPLACE THE EXISTING HUB. THE PATIENT'S CONDITION IS REPORTED AS FINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17321389 ↗

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