ARROW IPN030066 (REF CS-12123-F)Recalls & reported problems

Summary

The FDA's MAUDE database contains 21 adverse event reports that list this exact device (DI 00801902102119), received between Jun 6, 2022 and Apr 9, 2026 — classified as 1 death, 2 injuries, 18 malfunctions.

The most frequently reported specific device problem is “Material Twisted/Bent” (4 reports).

4 other recalls cover devices cleared under the same FDA submission (K970864); 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 21 most recent of 21 reports, in the reporter's own words as published by the FDA.

• InjuryApr 9, 2026Crack; Migration

  IT WAS REPORTED THAT "THE SUTURE WINGS OF THE 3-LUMEN CENTRAL VENOUS CATHETER WERE CRACKED AND COULD NO LONGER SECURE THE CATHETER IN PLACE. "ADDITIONAL INFORMATION RECEIVED STATES "THERE WAS NO SERIOUS CLINICAL CONSEQUENCES AS WE REACTED QUICKLY AND MANUAL COMPRESSION WAS IMMEDIATELY APPLIED TO THE PUNCTURE SITE. HOWEVER, THE PATIENT LOST AN AMOUNT OF BLOOD EQUIVALENT TO ONE UNIT OF PACKED RED BLOOD CELLS, AS THE DIALYSIS SESSION COULD NOT BE REINFUSED; THEREFORE, A BLOOD TRANSFUSION WAS REQUIRED. A NEW CATHETER WAS INSERTED. THE PATIENT'S CURRENT CONDITION IS UNKNOWN AT THIS TIME.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 24830476 ↗
• MalfunctionMar 17, 2026Break; Physical Resistance/Sticking

  IT WAS REPORTED THAT "THE IV SET WAS CONNECTED TO THE RED PORT OF THE CVC. UPON ATTEMPTING TO DISCONNECT THE IV SET, SIGNIFICANT RESISTANCE WAS ENCOUNTERED. AFTER REMOVAL, IT WAS DISCOVERED THAT THE DISTAL TIP OF THE IV SET HAD BROKEN OFF AND REMAINED LODGED INSIDE THE RED PORT OF THE CVC". THE USER CHANGED TO A NEW SET TO COMPLETE THE PROCEDURE. 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 24618252 ↗
• MalfunctionJan 15, 2026Unraveled Material

  IT WAS REPORTED THAT: CATHETER WAS USED FOR EMERGENCY DIALYSIS FOR HYPERKALEMIA AND METABOLIZED ACIDOSIS. THE GUIDEWIRE UNRAVELED DURING REMOVAL AT THE END OF CVC INSERTION, WITH SUSPICION OF EMBOLIZATION OF A PORTION OF THE GUIDEWIRE INTO THE PATIENT'S SYSTEMIC CIRCULATION." AN ECHOCARDIOGRAM CONFIRMED THAT NONE OF THE GUIDEWIRE REMAINED INSIDE THE PATIENT. THERE WAS NO PATIENT HARM OR INJURY. THE PATIENT HAD GOOD CLINICAL PROGRESS IN THE DAYS FOLLOWING THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24079408 ↗
• MalfunctionSep 29, 2025Crack; Gas/Air Leak; Crack; Gas/Air Leak

  IT WAS REPORTED THAT "NO VACUUM DURING ASPIRATION. DR NOTICED CRACK ON PLASTIC PART OF NEEDLE. DR MANAGED TO COMPLETE PROCEDURE AFTER OPENING THE 3RD PACK/ATTEMPT. THEY DID NOT REALIZE WHAT WAS WRONG WITH 1ST ATTEMPT AND WITH SECOND TIME ASPIRATING AIR, THEY CHECKED THE NEEDLE AND SAW CRACK." THE DEVICE WAS REMOVED AND REPLACED, AND A THIRD SET WAS USED SUCCESSFULLY. THERE WAS NO PATIENT HARM OR INJURY. NO MEDICAL INTERVENTION REQUIRED. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "FINE". ASSOCIATED MDR NUMBERS INCLUDE: 3006425876-2025-00889.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23166220 ↗
• MalfunctionSep 29, 2025Crack; Gas/Air Leak; Crack; Gas/Air Leak

  IT WAS REPORTED THAT "NO VACUUM DURING ASPIRATION. DR NOTICED CRACK ON PLASTIC PART OF NEEDLE. DR MANAGED TO COMPLETE PROCEDURE AFTER OPENING THE 3RD PACK/ATTEMPT. THEY DID NOT REALIZE WHAT WAS WRONG WITH 1ST ATTEMPT AND WITH SECOND TIME ASPIRATING AIR, THEY CHECKED THE NEEDLE AND SAW CRACK." THE DEVICE WAS REMOVED AND REPLACED, AND A THIRD SET WAS USED SUCCESSFULLY. 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 23166202 ↗
• MalfunctionJul 3, 2025Device Damaged Prior to Use; Device Damaged Prior to Use

  IT WAS REPORTED THAT "FOUND GUIDEWIRE IS DAMAGED AFTER OPENING THE SET." THIS WAS FOUND PRIOR TO USE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22396518 ↗
• MalfunctionMay 7, 2025Backflow; Failure to Seal; Backflow; Failure to Seal

  IT WAS REPORTED "INSERTION OF A DIALYSIS CATHETER IN THE INTENSIVE CARE UNIT. WHEN THE INTERN INSERTED THE CATHETER, AND THEN WHEN THE NURSE CONNECTED IT, THE CLAMP ON THE 'VENOUS' LINE WAS NOT SUFFICIENTLY EFFECTIVE. DESPITE CLAMPING, THE BLOOD WAS BEADING AND FLOWING BACK SLOWLY. NO PROBLEM OBSERVED ON THE ARTERIAL LINE. DOCTOR INFORMED, NEED TO CHECK CLAMPING AND PLUG JUST AFTER POSITIVE PRESSURE LOCK." THE PATIENT'S CURRENT CONDITION IS REPORTED AS "UNKNOWN" AT THIS TIME. ADDITIONAL INFORMATION WAS REQUESTED FROM THE CUSTOMER; HOWEVER, FURTHER DETAILS HAVE NOT BEEN PROVIDED AT THIS TIME.

  Patient problems: Insufficient Information

  MAUDE report 21975842 ↗
• MalfunctionSep 11, 2024Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED " IN ICU THE SWG WAS FOUND KINKED PRIOR TO THE PATIENT." THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20193579 ↗
• MalfunctionJul 29, 2024Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT "IN ICU, THE DOCTOR FOUND THE SWG KINKED DURING USED ON THE PATIENT." THE USER CHANGED A NEW SET. NO MEDICAL I NTERVENTION WAS REQUIRED. THE PATIENT'S CONDITION IS REPORTED AS "FINE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19849939 ↗
• MalfunctionJul 29, 2024Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT "IN ICU, THE DOCTOR FOUND THE SWG KINKED DURING USED ON THE PATIENT." THE USER CHANGED A NEW SET. NO MEDICAL I NTERVENTION WAS REQUIRED. THE PATIENT'S CONDITION IS FINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19849887 ↗
• MalfunctionJul 12, 2024Contamination /Decontamination Problem; Contamination /Decontamination Problem

  IT WAS REPORTED THAT: "THE CATHETER WAS INSERTED ON (B)(6) 2024. ON (B)(6), IT BEGAN TO MALFUNCTION, AND A CARE TAKER PRESCRIBED THAT THE LINES BE REVERSED. ON (B)(6), AS THE MALFUNCTION APPEARED TO BE SIGNIFICANT AND PRESSURE ON THE CIRCUIT WAS INCREASING, DIALYSIS WAS STOPPED. WHEN THE CATHETER WAS TESTED AGAIN BY THE NURSE, WHILE ASPIRATING, SHE "FOUND AND REMOVED" SOME MATERIAL THAT WE DID NOT IDENTIFY. AT FIRST SIGHT, IT APPEARS TO BE "INERT" MATERIAL, I.E. PLASTIC RATHER THAN A FIBRIN DEPOSIT AS WE HAD THOUGHT. WE DON'T KNOW WHERE IT CAME FROM. THE PATIENT DID NOT EXPERIENCE ANY SIGNS OR SYMPTOMS BECAUSE OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19728373 ↗
• MalfunctionJun 4, 2024Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED "DURING THE PROCEDURE WHEN THE DOCTOR TRIED TO ADVANCE THE GUIDEWIRE, DOCTOR WAS UNABLE TO DO SO. WHEN THE GUIDEWIRE WAS REMOVED IT WAS NOTICED THAT THE WIRE HAD 'CURLED' AND WAS KINKED. ANOTHER SET WAS OPENED TO COMPLETE THE PROCEDURE." THERE WAS NO PATIENT HARM OR INJURY. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "FINE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19461026 ↗
• MalfunctionMay 17, 2024Unraveled Material; Unraveled Material

  IT WAS REPORTED THAT: "UPON ATTEMPTING TO REMOVE THE GUIDEWIRE THEY ENCOUNTERED RESISTANCE WHICH RESULTED IN HAVING TO REMOVE THE WIRE & CVC TOGETHER. THE TIP WAS INTACT BUT APPROX 2 CM FROM THE TIP OF THE CVC AT THE MIDPOINT OF THE WIRE IT HAD STARTED TO UNWIND." A SECOND CVC WAS PLACED WITH NO ISSUE. THERE WAS NO PATIENT HARM OR CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19339535 ↗
• MalfunctionMay 14, 2024Material Separation; Unraveled Material; Material Separation; Unraveled Material

  IT WAS REPORTED THAT "DURING INSERTION, THE SURGEON HAD TO USE FORCE TO REMOVE THE SWG FROM CATHETER. THE SWG TIP WAS UNRAVELED. IT WAS DECIDED TO REMOVE THE CATHETER, AND A PART OF THE SWG WAS FOUND STUCK ON THE DISTAL END OF THE CATHETER. DURING THE INSERTION PROCEDURE, THE SWG GOT DAMAGED BY THE DILATOR AND WAS DEFORMED DURING DILATATION OF THE VEIN WHICH CAUSED THE SWG TO BEND. THERE WAS NO CLINICAL CONSEQUENCES TO THE PATIENT.".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19308439 ↗
• MalfunctionMay 9, 2024Unraveled Material; Unraveled Material

  IT WAS REPORTED "ON FRIDAY, A 3-LUMEN CATHETER WAS DEFECTIVE DURING THE PROCEDURE. WHEN PULLING OUT THE GUIDE WIRE, IT CAME COMPLETELY UNRAVELED." NO PATIENT HARM OR INJURY. NO MEDICAL INTERVENTION REQUIRED. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "POOR". IT WAS REPORTED THEIR CURRENT CONDITION IS UNRELATED TO THE EVENT.

  Patient problems: Insufficient Information

  MAUDE report 19278441 ↗
• MalfunctionFeb 13, 2024Material Deformation; Material Deformation

  IT WAS REPORTED THAT"ON JANUARY 15TH, THE EMERGENCY GENERAL HOSPITAL NOTIFIED THE DEALER OF THE CS-12123-F HEMODIALYSIS CATHETER USED BY THE HOSPITAL. THE PATIENT UNDERWENT PUNCTURE OF THE CATHETER FOR DIALYSIS AT THE HOSPITAL, AND THEN LEFT THE HOSPITAL TO GO HOME. DURING THEIR STAY AT HOME, THE CATHETER FELL OFF AND WAS IMMEDIATELY SENT TO THE HOSPITAL FOR RESCUE. THE DOCTOR REPORTED TEARING OF THE SUTURED WING AND SUSPECTED QUALITY ISSUES WITH THE PRODUCT. THEREFORE, AN ADVERSE EVENT WAS REPORTED TO THE MEDICAL DEPARTMENT. AT PRESENT, THERE IS NO FURTHER NOTICE FROM THE HOSPITAL OR CLINICAL DEPARTMENT." AWAITING ADDITIONAL INFORMATION AS THE MODEL NUMBER PROVIDED IS A 3 LUMEN CVC BUT THE EVENT DESCRIPTION REPORTED A HEMODIALYSIS CATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18693499 ↗
• MalfunctionNov 22, 2023Material Deformation; Material Deformation

  IT WAS REPORTED THAT "GUIDE WIRE DAMAGED AND NOT IN WORKING CONDITION". NO PATIENT HARM OR INJURY. THE PATIENT STATUS IS REPORTED AS "FINE". 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.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18196263 ↗
• DeathAug 29, 2023Material Separation; Material Separation

  IT WAS REPORTED "INCIDENT OCCURRED ON (B)(6) 2023. UNDER THE EFFECT OF TRACTION (PATIENT HAVING STOOD UP), THE INFUSION LINE OF THE CATHETER BROKE. (CATHETER INSERTED ON 28 JULY). THE DOCTOR WAS CALLED BY NURSES. DOCTOR INSTRUCTED TO IMMEDIATELY REMOVE THE CATHETER. WHEN THE NURSES ARRIVED, PATIENT WAS IN RESPIRATORY CARDIAC ARREST. CARDIOPULMONARY RESUSCITATION STARTED BY THE PARAMEDICAL TEAM AND CALL FOR RESUSCITATION. PATIENT DECEASED." IT WAS REPORTED BY THE HOSPITAL THAT THE PATIENT HAD BEEN IN FOLLOW-UP CARE AND REHABILITATION DEPARTMENT FOLLOWING A RECENT STROKE. "THE PARAMEDICAL TEAM NOTICED THAT THE CATHETER WAS CUT, SO THEY GOT THE DOCTOR ON CALL, WHO GAVE INSTRUCTIONS TO REMOVE THE DEVICE. PATIENT WAS IN CARDIAC ARREST WHEN THEY CAME BACK TO THE ROOM." THE TIME INTERVAL FROM WHEN THE ISSUE WAS DETECTED TO DEATH WAS 5 MINUTES. THE CAUSE OF DEATH IS REPORTED AS "UNEXPECTED CARDIORESPIRATORY ARREST". AN AUTOPSY WAS NOT PERFORMED.

  Patient problems: Cardiac Arrest

  MAUDE report 17640914 ↗
• MalfunctionAug 2, 2023Deformation Due to Compressive Stress; Deformation Due to Compressive Stress

  IT WAS REPORTED THE SPRING WIRE GUIDE WAS FOUND KINKED PRIOR TO PATIENT USE. NO PATIENT INVOLVEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17441742 ↗
• MalfunctionAug 2, 2023Deformation Due to Compressive Stress; Deformation Due to Compressive Stress

  IT WAS REPORTED THE SPRING WIRE GUIDE WAS FOUND KINKED PRIOR TO PATIENT USE. NO PATIENT INVOLVEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17441721 ↗
• InjuryJun 6, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE COMPLAINT IS REPORTED AS: "CHILD HAD A CENTRAL DIALYSIS CATHETER INSERTED FOR IMMUNO-ADSORPTION REGARDING THE TREATMENT OF AUTOIMMUNE ENCEPHALITIS. ON (B)(6) 2022 AT 6.45 AM, THE CATHETER WAS ACCIDENTALLY PULLED OFF BY THE CHILD. THIS WAS AN INVOLUNTARY MOVE BY THE CHILD WHILE HE WAS TRYING TO GET DRESSED. THERE WAS AN IMMEDIATE RESPIRATORY AND NEUROLOGICAL DISTRESS. A CEREBRAL AND THORACIC CT SCAN WAS PERFORMED AT 8.45AM, IT CONFIRMED A GAS EMBOLISM (PRESENCE OF INTRAVASCULAR AIR). THE CATHETER HAS NO FAILURE AND IS NOT THE CAUSE OF THE INCIDENT. THE AIR ENTERED THROUGH THE CUTANEOUS ORIFICE WHEN THE CATHETER WAS PULLED OFF." IT WAS REPORTED "THERE WAS SUDDEN RESPIRATORY AND NEUROLOGICAL DETERIORATION BECAUSE OF THE GAS EMBOLISM. WE PERFORMED AN INTUBATION, A MECHANICAL VENTILATION AND TRANSFERRED THE PATIENT TO INTENSIVE CARE. A HYPERBARIC CHAMBER SESSION WAS DONE. THE CHILD WAS HOSPITALIZED 15 DAYS IN INTENSIVE CARE AND THEN IN NEUROLOGY. THE PROGRESSION IS GOING TOWARDS SERIOUS DEFINITIVE NEUROLOGICAL SEQUELS BECAUSE OF THE GAS EMBOLISM."

  Patient problems: Air Embolism

  MAUDE report 14605542 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K970864. One submission often covers many models, so check the product and lot details in each record.

• Z-2376-2026 · Apr 21, 2026 · Open, Classified
  Description/REF: CVC/PSI KIT: 2 LUMEN 8 FR X 6 IN/ASK-42802-PLH; CVC KIT: 3-LUMEN 12 FR X 16 CM/AK-12123-F; CVC KIT: 3-LUMEN 12 FR X 20 CM/AK-15123-F; 3L CVC KIT: 7 FR X 16 CM/ASK-
• Z-1290-2022 · May 5, 2022 · Terminated
  Arrow Three-Lumen CVC
• Z-1672-2009 · May 8, 2009 · Terminated
  12 French 3 Lumen 20 cm Large-Bore Central Venous Catheters. Product numbers AK-15123-H, AK-15123-J, CS-15123-E, and MC-15123. The large-bore multiple-lumen catheter permits veno
• Z-1671-2009 · May 8, 2009 · Terminated
  12 French 3 Lumen 16 cm Large-Bore Central Venous Catheters. Product numbers AK-12123-H, CS-12123-E, MA-12123, and MC-12123. The large-bore multiple-lumen catheter permits venous