ARROW IPN033034Recalls & reported problems

Summary

The FDA's MAUDE database contains 41 adverse event reports that list this exact device (DI 00801902096326), received between May 13, 2024 and Jun 23, 2026 — classified as 41 malfunctions.

The most frequently reported specific device problem is “Crack” (36 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 25 most recent of 41 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 23, 2026Crack; Fluid/Blood Leak

  IT WAS REPORTED THAT ON (B)(6) 2026, THAT AN INDWELLING CANNON II PLUS CHRONIC HEMODIALYSIS CATHETER (CHDC), ORIGINALLY INSERTED ON (B)(6) 2026, EXHIBITED CRACKING AT THE LUER HUB/FITTING ACCOMPANIED BY BLOOD OOZING FROM THE AFFECTED AREA. THERE WERE NO REPORTS OF PATIENT INJURY, HARM, OR ADVERSE HEALTH CONSEQUENCES ASSOCIATED WITH THIS EVENT. THE PATIENT'S CONDITION WAS REPORTED AS "FINE." THE AFFECTED CATHETER WAS REMOVED AND REPLACED WITH ANOTHER DEVICE. NO ADDITIONAL MEDICAL OR SURGICAL INTERVENTION WAS REQUIRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25593864 ↗
• MalfunctionJun 23, 2026Crack; Fluid/Blood Leak

  IT WAS REPORTED THAT ON (B)(6) 2026, THAT AN INDWELLING CANNON II PLUS CHRONIC HEMODIALYSIS CATHETER (CHDC), ORIGINALLY INSERTED ON (B)(6) 2026, EXHIBITED CRACKING AT THE LUER HUB/FITTING ACCOMPANIED BY BLOOD OOZING FROM THE AFFECTED AREA. THERE WERE NO REPORTS OF PATIENT INJURY, HARM, OR ADVERSE HEALTH CONSEQUENCES ASSOCIATED WITH THIS EVENT. THE PATIENT'S CONDITION WAS REPORTED AS "FINE." THE AFFECTED CATHETER WAS REMOVED AND REPLACED WITH ANOTHER DEVICE. NO ADDITIONAL MEDICAL OR SURGICAL INTERVENTION WAS REQUIRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25593791 ↗
• MalfunctionJun 23, 2026Crack; Fluid/Blood Leak

  IT WAS REPORTED THAT ON (B)(6) 2026, THAT AN INDWELLING CANNON II PLUS CHRONIC HEMODIALYSIS CATHETER (CHDC), ORIGINALLY INSERTED ON (B)(6) 2026, EXHIBITED CRACKING AT THE LUER HUB/FITTING ACCOMPANIED BY BLOOD OOZING FROM THE AFFECTED AREA. THERE WERE NO REPORTS OF PATIENT INJURY, HARM, OR ADVERSE HEALTH CONSEQUENCES ASSOCIATED WITH THIS EVENT. THE PATIENT'S CONDITION WAS REPORTED AS "FINE." THE AFFECTED CATHETER WAS REMOVED AND REPLACED WITH ANOTHER DEVICE. NO ADDITIONAL MEDICAL OR SURGICAL INTERVENTION WAS REQUIRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25593705 ↗
• MalfunctionMay 11, 2026Crack; Fluid/Blood Leak

  IT WAS REPORTED THAT ON (B)(6) 2026, DURING USE ON A PATIENT, THE LUER HUB/FITTING OF A CHRONIC HEMODIALYSIS CATHETER (CHDC) WAS FOUND TO BE CRACKED AND LEAKING. THE CATHETER HAD BEEN INSERTED ON (B)(6) 2026. THERE WERE NO REPORTS OF PATIENT INJURY, HARM, OR ADVERSE HEALTH CONSEQUENCES ASSOCIATED WITH THE EVENT. THE PATIENT'S CONDITION WAS REPORTED AS FINE. NO MEDICAL INTERVENTION WAS NECESSARY, AND THE PROCEDURE WAS COMPLETED AFTER CHANGING TO ANOTHER DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25137503 ↗
• MalfunctionMay 4, 2026Crack; Fluid/Blood Leak

  IT WAS REPORTED THAT "ON 09APR2026 DURING PATIENT USE, THE LUER HUB/FITTING WAS FOUND CRACKED AND LEAKING." THERE WERE NO REPORTS OF PATIENT INJURY, HARM, OR ADVERSE HEALTH CONSEQUENCES ASSOCIATED WITH THE EVENT. THE PATIENT'S CONDITION WAS REPORTED AS FINE. NO MEDICAL INTERVENTION WAS NECESSARY, AND THE PROCEDURE WAS COMPLETED AFTER SWITCHING TO ANOTHER DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25071741 ↗
• MalfunctionApr 20, 2026Crack; Fluid/Blood Leak

  IT WAS REPORTED THAT: "ON (B)(6) 2026, LEUR HUB WAS FOUND TO HAVE A CRACK AND BLEEDING DURING PRE MACHINE TESTING OF THE CATHETER. THERE WAS NO REPORTED PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24925101 ↗
• MalfunctionApr 17, 2026Crack; Fluid/Blood Leak

  IT WAS REPORTED THAT: "ON (B)(6) 2026, LEUR HUB WAS FOUND TO HAVE A CRACK AND BLEEDING DURING PRE-MACHINE TESTING OF THE CATHETER. THERE WAS NO REPORTED PATIENT HARM."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24908201 ↗
• MalfunctionApr 10, 2026Crack; Fluid/Blood Leak

  IT WAS REPORTED THAT: "(B)(6) 2026, BEFORE THE PATIENT UNDERWENT DIALYSIS ON THE MACHINE, IT WAS FOUND THAT THERE WERE CRACKS AND BLEEDING ON THE LUER HUB. NO HARM FOR THE PATIENT. THE PATIENT CONDITION WAS REPORTED AS FINE. NO MEDICAL INTERVENTION WAS REQUIRED. THEY REPLACED THE DEVICE TO RESOLVE THE ISSUE."

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 24842951 ↗
• MalfunctionApr 10, 2026Crack; Fluid/Blood Leak

  IT WAS REPORTED THAT: "16 MAR 2026, BEFORE THE PATIENT UNDERWENT DIALYSIS ON THE MACHINE, IT WAS FOUND THAT THERE WERE CRACKS AND BLEEDING ON THE LUER HUB. NO HARM FOR THE PATIENT. THE PATIENT CONDITION WAS REPORTED AS FINE. NO MEDICAL INTERVENTION WAS REQUIRED. THEY REPLACED THE DEVICE TO RESOLVE THE ISSUE."

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 24838382 ↗
• MalfunctionDec 1, 2025Crack; Crack

  IT WAS REPORTED THAT"ON (B)(6) 2025, ACCORDING TO THE CUSTOMER'S FEEDBACK, WHEN THE SYRINGE WAS ROUTINELY USED TO TEST THE TIGHTNESS OF THE DIALYSIS TUBE BEFORE THE PATIENT WAS PUT ON THE MACHINE FOR DIALYSIS, THE LEAK WAS FOUND. AFTER CAREFUL INSPECTION OF THE JOINT, IT WAS FOUND THAT THE LUER HUB/FITTING HAS CRACK. THIS WAS USED ABOUT 5 MONTHS. A NEW DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO MEDICAL DEVICE INTERVENTION NEEDED."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23678728 ↗
• MalfunctionDec 1, 2025Crack; Crack

  IT WAS REPORTED THAT "ON (B)(6) 2025, ACCORDING TO THE CUSTOMER'S FEEDBACK, WHEN THE SYRINGE WAS ROUTINELY USED TO TEST THE TIGHTNESS OF THE DIALYSIS TUBE BEFORE THE PATIENT WAS PUT ON THE MACHINE FOR DIALYSIS, THE LEAK WAS FOUND. AFTER CAREFUL INSPECTION OF THE JOINT, IT WAS FOUND THAT THE LUER HUB/FITTING HAS CRACK. THIS WAS USED ABOUT 5 MONTHS. A NEW DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO MEDICAL DEVICE INTERVENTION NEEDED."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23678707 ↗
• MalfunctionDec 1, 2025Crack; Crack

  IT WAS REPORTED THAT: "ON (B)(6) 2025, ACCORDING TO THE CUSTOMER'S FEEDBACK, WHEN THE SYRINGE WAS ROUTINELY USED TO TEST THE TIGHTNESS OF THE DIALYSIS TUBE BEFORE THE PATIENT WAS PUT ON THE MACHINE FOR DIALYSIS, THE LEAK WAS FOUND. AFTER CAREFUL INSPECTION OF THE JOINT, IT WAS FOUND THAT THE LUER HUB/FITTING HAS CRACK. INVOLVED 2 PC." THIS WAS USED ABOUT 5.5 MONTHS. "

  Patient problems: Insufficient Information

  MAUDE report 23678641 ↗
• MalfunctionDec 1, 2025Crack; Crack

  IT WAS REPORTED THAT: "ON (B)(6) 2025, ACCORDING TO THE CUSTOMER'S FEEDBACK, WHEN THE SYRINGE WAS ROUTINELY USED TO TEST THE TIGHTNESS OF THE DIALYSIS TUBE BEFORE THE PATIENT WAS PUT ON THE MACHINE FOR DIALYSIS, THE LEAK WAS FOUND. AFTER CAREFUL INSPECTION OF THE JOINT, IT WAS FOUND THAT THE LUER HUB/FITTING HAS CRACK. INVOLVED 2 PC." THIS WAS USED ABOUT 5.5 MONTHS. "

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23678616 ↗
• MalfunctionMay 8, 2025Crack; Crack

  IT WAS REPORTED "ON (B)(6) 2025, IN THE COURSE OF DIALYSING A PATIENT, THE DOCTOR FOUND LUER HUB/FITTING HAS CRACK." THE USER CHANGED TO A NEW SET TO RESOLVE THE ISSUE. THERE WAS NO PATIENT HARM OR INJURY. NO MEDICAL INTERVENTION REQUIRED. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "FINE". ASSOCIATED MDR NUMBERS INCLUDE: 9680794-2025-00440, 9680794-2025-00441, AND 9680794-2025-00442.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21985410 ↗
• MalfunctionMay 8, 2025Crack; Crack

  IT WAS REPORTED "(B)(6) 2025, IN THE COURSE OF DIALYSING A PATIENT, THE DOCTOR FOUND LUER HUB/FITTING HAS CRACK." THE USER CHANGED TO A NEW SET TO RESOLVE THE ISSUE. THERE WAS NO PATIENT HARM OR INJURY. NO MEDICAL INTERVENTION REQUIRED. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "FINE". ASSOCIATED MDR NUMBERS INCLUDE: 9680794-2025-00441, AND 9680794-2025-00442.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21985367 ↗
• MalfunctionMay 8, 2025Crack; Crack

  IT WAS REPORTED "ON (B)(6) 2025, IN THE COURSE OF DIALYSING A PATIENT, THE DOCTOR FOUND LUER HUB/FITTING HAS CRACK." THE USER CHANGED TO A NEW SET TO RESOLVE THE ISSUE. THERE WAS NO PATIENT HARM OR INJURY. NO MEDICAL INTERVENTION REQUIRED. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "FINE". ASSOCIATED MDR NUMBERS INCLUDE: 9680794-2025-00440 AND 9680794-2025-00442.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21985349 ↗
• MalfunctionFeb 11, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT "DURING OPERATION, WHEN THE DOCTOR OPENED THE PACKAGE, FOUND THE PEEL-AWAY SHEATH SPLIT". THE DEVICE WAS NOT USED ON THE PATIENT. THEY CHANGED A NEW ONE TO RESOLVE THE ISSUE. NO HARM FOR THE PATIENT. THE PATIENT CONDITION IS FINE. NO MEDICAL INTERVENTION WAS REQUIRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21356098 ↗
• MalfunctionJan 29, 2025Crack; Crack

  IT WAS REPORTED THAT "THE DOCTOR FOUND THE LUER HUB/FITTING HAS CRACK DURING USED ON THE PATIENT". THEY CHANGED A NEW ONE TO RESOLVE THE ISSUE. NO HARM FOR THE PATIENT. THE PATIENT CONDITION IS FINE. NO MEDICAL INTERVENTION WAS REQUIRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21264258 ↗
• MalfunctionJan 15, 2025Crack; Crack

  IT WAS REPORTED THAT "THE DOCTOR FOUND THE LUER HUB/FITTING HAS CRACK DURING USED ON THE DIFFERENT PATIENT". THEY CHANGED A NEW ONE TO RESOLVE THE ISSUE. NO HARM FOR THE PATIENT. THE PATIENT CONDITION IS FINE. NO MEDICAL INTERVENTION WAS REQUIRED. THE ASSOCIATED EMDR REPORT NUMBERS ARE 9680794-2025-00088.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21159595 ↗
• MalfunctionJan 15, 2025Crack; Crack

  IT WAS REPORTED THAT "THE DOCTOR FOUND THE LUER HUB/FITTING HAS CRACK DURING USED ON THE DIFFERENT PATIENT". THEY CHANGED A NEW ONE TO RESOLVE THE ISSUE. NO HARM FOR THE PATIENT. THE PATIENT CONDITION IS FINE. NO MEDICAL INTERVENTION WAS REQUIRED. THE ASSOCIATED EMDR REPORT NUMBERS ARE 9680794-2025-00087.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21159585 ↗
• MalfunctionJan 10, 2025Crack; Crack

  IT WAS REPORTED THAT "THE DOCTOR FOUND LUER HUB/FITTING HAS CRACK DURING USED ON THE PATIENT". THEY CHANGED A NEW ONE TO RESOLVE THE ISSUE. NO HARM FOR THE PATIENT. THE PATIENT CONDITION IS FINE. NO MEDICAL INTERVENTION WAS REQUIRED. THE ASSOCIATED EMDR REPORT NUMBERS ARE 9680794-2025-00045 AND 9680794-2025-00046.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21124401 ↗
• MalfunctionJan 10, 2025Crack; Crack

  IT WAS REPORTED THAT "THE DOCTOR FOUND LUER HUB/FITTING HAS CRACK DURING USED ON THE PATIENT". THEY CHANGED A NEW ONE TO RESOLVE THE ISSUE. NO HARM FOR THE PATIENT. THE PATIENT CONDITION IS FINE. NO MEDICAL INTERVENTION WAS REQUIRED. THE ASSOCIATED EMDR REPORT NUMBERS ARE 9680794-2025-00046.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21124118 ↗
• MalfunctionJan 8, 2025Crack; Crack

  IT WAS REPORTED THAT "THE DOCTOR FOUND THE LUER HUB/FITTING HAS CRACK DURING USED ON THE PATIENT". THEY CHANGED A NEW ONE TO RESOLVE THE ISSUE. NO HARM FOR THE PATIENT. THE PATIENT CONDITION IS FINE. NO MEDICAL INTERVENTION WAS REQUIRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21101316 ↗
• MalfunctionDec 6, 2024Crack; Crack

  IT WAS REPORTED "ON (B)(6) 2024, THE DOCTOR FOUND THE LUER HUB/FITTING HAS A CRACK DURING USE ON THE PATIENT. THEY CHANGED A NEW ONE TO RESOLVE THE ISSUE. NO HARM FOR THE PATIENT. THE PATIENT'S CONDITION IS FINE. NO MEDICAL INTERVENTION WAS REQUIRED."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20866123 ↗
• MalfunctionDec 4, 2024Crack; Crack

  IT WAS REPORTED " ON (B)(6) 2024, THE DOCTOR FOUND THE LUER HUB/FITTING HAS A CRACK DURING USE ON THE PATIENT." THE OPERATOR 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 20843283 ↗

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-2156-2026 · Apr 10, 2026 · Open, Classified
  Arrow Edge Hemodialysis Catheterization Product, REF: CS-15242-I, CS-15282-I, CS-15322-I
• 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