ARROW IPN033046Recalls & reported problems

Summary

The FDA's MAUDE database contains 29 adverse event reports that list this exact device (DI 00801902096388), received between Apr 8, 2021 and Feb 20, 2026 — classified as 29 malfunctions.

The most frequently reported specific device problem is “Crack” (11 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 25 most recent of 29 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 20, 2026Material Separation

  IT WAS REPORTED THAT, "ONE HALF OF THE INTRODUCER SHEATH'S HEMOSTATIC VALVE COMPLETELY DETACHED DURING CATHETER INSERTION, HAVING BEEN PUSHED INTO THE SHEATH BETWEEN THE TWO BRANCHES. SINCE THIS HALF WAS NO LONGER VISIBLE, AND THERE WAS A RISK OF THIS STRUCTURE ENTERING THE BLOODSTREAM IF WE CONTINUED INSERTING THE CATHETER, IT WAS NECESSARY TO EXTERIORIZE THE CATHETER, REMOVE HALF OF THE HEMOSTATIC VALVE, AND REINSERT THE CATHETER. THERE WERE NO IMMEDIATE COMPLICATIONS, SUCH AS BLEEDING OR AIR EMBOLISM, AND THE FACT THAT PART OF THE CATHETER WAS ALREADY INSIDE THE SHEATH PREVENTED BLOOD FROM LEAKING". NO PATIENT HARM OR INJURY. THE PATIENT STATUS IS REPORTED AS "FINE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24400193 ↗
• MalfunctionJan 2, 2026Crack

  IT WAS REPORTED THAT: "THE LUER HUB WAS FOUND CRACKED. THE PATIENT WAS REPORTED AS FINE POST THE PROCEDURE.".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23942746 ↗
• MalfunctionJan 2, 2026Crack

  IT WAS REPORTED THAT: "THE LUER HUB WAS FOUND CRACKED. THE PATIENT WAS REPORTED AS FINE POST THE PROCEDURE."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23942745 ↗
• MalfunctionJan 2, 2026Crack

  IT WAS REPORTED THAT"ON (B)(6) 2025, THE CATHETER TIP WAS FOUND CRACKED. THE PATIENT WAS REPORTED AS FINE POST THE PROCEDURE. INVOLVED 1 PC."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23942696 ↗
• MalfunctionDec 3, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT " THE Y CONNECTOR WAS NOT SEALING AND CAUSED A LEAK USED 3 CATHETERS TO FIND ONE THAT WORKED. THERE WAS NO VISIBLE DAMAGE. THE PATIENT EXPERIENCED SUBSTANTIAL BLEEDING NOT NORMALLY EXPERIENCED IN THESE CASES. THERE WAS NO OTHER PATIENT INJURY." ASSOCIATED COMPLAINTS: (B)(4).

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 23705731 ↗
• MalfunctionDec 3, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT " THE Y CONNECTOR WAS NOT SEALING AND CAUSED A LEAK USED 3 CATHETERS TO FIND ONE THAT WORKED. THERE WAS NO VISIBLE DAMAGE. THE PATIENT EXPERIENCED SUBSTANTIAL BLEEDING NOT NORMALLY EXPERIENCED IN THESE CASES. THERE WAS NO OTHER PATIENT INJURY." ASSOCIATED COMPLAINTS: . 9680794-2025-01004 AND 9680794-2025-01003.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 23705317 ↗
• MalfunctionDec 3, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT " THE Y CONNECTOR WAS NOT SEALING AND CAUSED A LEAK USED 3 CATHETERS TO FIND ONE THAT WORKED. THERE WAS NO VISIBLE DAMAGE. THE PATIENT EXPERIENCED SUBSTANTIAL BLEEDING NOT NORMALLY EXPERIENCED IN THESE CASES. THERE WAS NO OTHER PATIENT INJURY." ASSOCIATED COMPLAINTS: 9680794-2025-01005, 9680794-2025-01004 AND 9680794-2025-01003.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 23705272 ↗
• MalfunctionNov 28, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT: "THE Y-CONNECTOR WAS FOUND TO BE LEAKING. HE TRIED SWAPPING OUT FOR ANOTHER 23CM SIZE CATHETER BUT IT THE Y-CONNECTER STILL LEAKED, SO THEY HAD TO OPEN A DIFFERENT SIZE TO USE THE Y-CONNECTOR. THE PATIENT EXPERIENCED BLEEDING IN EXCESS OF WHAT IS EXPECTED FOR THIS CASE."

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 23670902 ↗
• MalfunctionNov 28, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT: "THE Y-CONNECTOR WAS FOUND TO BE LEAKING."

  Patient problems: Insufficient Information

  MAUDE report 23670876 ↗
• MalfunctionNov 20, 2025Incomplete or Inadequate Connection; Incomplete or Inadequate Connection

  IT WAS REPORTED THAT: "DURING INSERTION, UNABLE TO SCREW THE COMPRESSION CAP UNDER THE SLEEVE. ANOTHER KIT WAS USED OTO COMPLETE THE PROCEDURE. THERE WAS NO HARM OR CONSEQUENCE FOR THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23602634 ↗
• MalfunctionNov 11, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT: " AN 87-YEAR-OLD FEMALE DIALYSIS PATIENT, WHO REGULARLY ATTENDS DIALYSIS SESSIONS AND LIVES INDEPENDENTLY, EXPERIENCED AN INCIDENT INVOLVING HER CHRONIC ARROW (CANNON) DIALYSIS CATHETER. ON (B)(6), THE PATIENT WAS FOUND WITH BLEEDING DUE TO A RUPTURE IN THE ARTERIAL EXTENSION LINE OF THE CATHETER. THE PREVIOUS EVENING, HER CONDITION HAD BEEN CONFIRMED AS STABLE BY HER HOME NURSE. THE PATIENT HAS A KNOWN HISTORY OF SKIN SENSITIVITY AND FREQUENTLY SCRATCHES AROUND THE CATHETER SITE DUE TO IRRITATION FROM THE DRESSING. EMERGENCY SERVICES WERE CONTACTED, AND THE HOSPITAL RESPONDED BY CLAMPING THE CATHETER AND REPLACING THE DAMAGED EXTENSION LINE. THE PATIENT IS CURRENTLY STABLE. INITIAL OBSERVATIONS SUGGEST THAT THE DAMAGE RESEMBLES A CLEAN CUT RATHER THAN A TEAR CAUSED BY PULLING."

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 23520348 ↗
• MalfunctionFeb 10, 2025Incomplete or Inadequate Connection; Incomplete or Inadequate Connection

  IT WAS REPORTED THAT "DURING THE PLACEMENT OF A CHRONIC DIALYSIS CATHETER THE COMPRESSION SLEEVE (GREEN COMPONENT UNDER THE COMPRESSION CAP) DID NOT ATTACH PROPERLY. AND THUS, THE VASCULAR SURGEON COULD NOT CONNECT THE CATHETER WITH THE EXTENSION LINES. THE VASCULAR SURGEON USED ANOTHER COMPRESSION SLEEVE (SHE HAD TO OPEN A REPAIR KIT) AND THIS SLEEVE WAS FINE AND THE PLACEMENT OF THE CATHETER WAS SUCCESSFUL". THE PATIENT IS FINE AND HAD NO HARM OR INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21343921 ↗
• MalfunctionJan 9, 2025Material Deformation; Material Deformation

  IT WAS REPORTED THAT "THE VALVE IN THE SHEATH CAME LOOSE AND TILTED, PREVENTING INSERTION OF THE DIALYSIS CATHETER. AS A RESULT, A NEW SET HAD TO BE USED". THE CONDITION OF THE PATIENT IS REPORTED TO BE 'FINE'.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21111844 ↗
• MalfunctionDec 17, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED "ON (B)(6) 2024, THE EXTENSION LINE WAS FOUND LEAKING DURING USE ON THE PATIENT." THE USER CHANGED TO A NEW DEVICE TO RESOLVE THE ISSUE. 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 20951396 ↗
• MalfunctionDec 17, 2024Crack; Crack

  IT WAS REPORTED "ON 21 NOV 2024, THE LUER HUB/FITTING HAS CRACK DURING USE ON THE PATIENT." THEY USER CHANGED TO A NEW ONE TO RESOLVE THE ISSUE. 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 20951333 ↗
• MalfunctionDec 17, 2024Crack; Crack

  IT WAS REPORTED "ON (B)(6) 2024, THE LUER HUB/FITTING HAS CRACK DURING USE ON THE PATIENT." THEY USER CHANGED TO A NEW ONE TO RESOLVE THE ISSUE. 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 20951265 ↗
• MalfunctionNov 15, 2024Mechanical Problem; Material Split, Cut or Torn; Mechanical Problem; Material Split, Cut or Torn

  IT WAS REPORTED THAT "ON (B)(6) 2024 AN ATTEMPT WAS MADE TO PLACE A CATHETER, BUT THE SHEATH TORE DURING INSERTION. REASON BROKEN: SHEATH FOR PUNCTURING: THE DISTAL END (THE VALVE) HAS A DEFECT IN THE WING AND IS OPEN BUT DOES NOT CLOSE BACK AS IT SHOULD". THE DEVICE WAS REMOVED AND REPLACED. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "FINE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20696372 ↗
• MalfunctionNov 13, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED " JUNCTURE HUB LEAK DURING USE ON THE PATIENT." THERE WAS NO MEDICAL INTERVENTION REQUIRED. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "FINE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20673957 ↗
• MalfunctionJul 25, 2024Material Separation; Separation Failure; Material Separation; Separation Failure

  IT WAS REPORTED THAT: "THE SHEATH DID NOT PEEL AWAY AS IT SHOULD HAVE." ADDITIONAL INFORMATION HAS BEEN REQUESTED FROM THE CUSTOMER.

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

  MAUDE report 19826721 ↗
• MalfunctionJun 26, 2024Separation Failure; Separation Failure

  IT WAS REPORTED "DURING PROCEDURE THE DOCTOR COULD NOT PEEL THE CATH, HAD TO USE SCISSORS". THE SHEATH WAS REMOVED ENTIRELY. 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 19613606 ↗
• MalfunctionApr 9, 2024Crack; Crack

  IT WAS REPORTED "THE LUER HUB HAS A CRACK DURING USE ON THE PATIENT. THEY CHANGED A NEW ONE." 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 19069606 ↗
• MalfunctionApr 9, 2024Crack; Crack

  IT WAS REPORTED "THE LUER HUB HAS A CRACK DURING USE ON THE PATIENT. THEY CHANGED A NEW ONE". 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 19069330 ↗
• MalfunctionMar 29, 2024Crack; Crack

  IT WAS REPORTED THAT: "01 MAR 2024, THE CONNECTOR CRACKED DURING THE PROCESS OF TIGHTENING THE CONNECTOR TO THE TUBING. THEY WERE UNABLE TO WITHDRAW THE CATHETER DURING TREATMENT AND COULD ONLY BE FIXED WITH STERILE TAPE TO TEMPORARILY MAINTAIN TREATMENT." THEY WERE REPORTED AS FINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19002103 ↗
• MalfunctionJan 12, 2024Crack; Crack

  IT WAS REPORTED THAT: (B)(6) 2023, THE DOCTOR FOUND THE LUER HUB/FITTING HAS CRACK DURING USE ON THE PATIENT. PATIENT WAS REPORTED AS GOOD POST PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18500984 ↗
• MalfunctionDec 4, 2023Crack; Crack

  IT WAS REPORTED THAT "ON (B)(6) 2023, THE DOCTOR FOUND THE LUER HUB/FITTING HAS A CRACK. IT WAS IDENTIFIED DURING USE ON THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18254667 ↗

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-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-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