Niagara catheter 5594150Recalls & reported problems

Summary

The FDA's MAUDE database contains 35 adverse event reports that list this exact device (DI 00801741045608), received between Dec 9, 2015 and Mar 9, 2026 — classified as 2 injuries, 33 malfunctions.

The most frequently reported specific device problem is “Material Frayed” (8 reports).

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 18, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 35 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 9, 2026Material Twisted/Bent

  IT WAS REPORTED THE GUIDEWIRE WAS FOUND TO BE DEFECTIVE¿BENT AND UNABLE TO BE REMOVED FROM THE PROBE, RENDERING IT UNUSABLE. NO OTHER INFORMATION WAS PROVIDED. 02/25/2026: IT WAS FOUND DURING AN INVESTIGATION A SEGMENT OF THE OUTER COIL WIRE APPEARED STRETCHED OUT NEAR THE DISTAL END OF THE GUIDEWIRE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24546082 ↗
• MalfunctionNov 20, 2024Material Deformation; Material Deformation

  IT WAS REPORTED THAT WHEN USING THE CATHETER, THE GUIDE WIRE WAS BENT AND COULD NOT BE WITHDRAWN FROM THE PUNCTURE NEEDLE AND COULD NOT BE USED. NO OTHER INFORMATION PROVIDED, AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20740525 ↗
• MalfunctionJul 30, 2024Material Deformation; Material Deformation

  IT WAS REPORTED BY THE CUSTOMER WHEN THE NEPHROLOGY DEPARTMENT USED A SHORT DIALYSIS CATHETER, IT WAS FOUND THAT THE SKIN EXPANDER WAS DAMAGED AND COULD NOT EXPAND THE SKIN NORMALLY. THE CATHETER CANNOT BE PLACED PROPERLY. ANOTHER WAS PLACED, SECOND PUNCTURE. NO INJURY REPORTED. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19864824 ↗
• MalfunctionFeb 7, 2024Material Frayed; Material Frayed

  IT WAS REPORTED THAT WHEN USING THE SHORT-TERM DIALYSIS CATHETER, THE OPERATOR FOUND THAT THE GUIDEWIRE COULD NOT PASS THROUGH THE NEEDLE PRIOR TO INSERTION INTO THE PATIENT. NO OTHER INFORMATION WAS PROVIDED. 01/16/2024: A GUIDEWIRE WAS RETURNED FOR EVALUATION AND WAS FOUND TO BE UNRAVELED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18665266 ↗
• MalfunctionJan 8, 2024Material Frayed; Material Frayed

  IT WAS REPORTED THAT ON (B)(6) 2023, DURING THE INSERTION OF A NIAGARA CATHETER, THE RESIDENT MANAGED TO PRICK AND MOUNT HIS GUIDE, BUT THE GUIDE FRAYED AT THE DISTAL END, MAKING IT IMPOSSIBLE FOR THE NEEDLE TO EXIT THE GUIDE. A NEW CATHETER OF THE SAME REFERENCE HAD TO BE INSERTED, THIS TIME WITHOUT INCIDENT. THEY DELAY IN PATIENT MANAGEMENT CAUSED BY THIS CHANGE OF CATHETER WAS MINIMAL. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18467587 ↗
• MalfunctionJun 5, 2023Crack; Crack

  IT WAS REPORTED THAT, "ON MONDAY, (B)(6), THE PLACEMENT OF A 15CM, 13.5 FR NIAGARA CATHETER IS SCHEDULED FOR INSERTION. AT THE TIME OF PUNCTURE, IT IS OBSERVED THAT THERE IS NO HERMETIC SEAL BETWEEN THE NEEDLE AND THE SYRINGE BECAUSE ADEQUATE SUCTION IS NOT OBSERVED AFTER THE PUNCTURE, WHICH IT IS NECESSARY TO OBTAIN VENOUS RETURN FROM THE VESSEL TO WHICH ONE WISHES TO ACCESS, WHEN ASPIRATING THE SOLUTION AND PRESSING THE PLUNGER, A LEAK IS OBSERVED BETWEEN IT, IT IS DECIDED TO USE ANOTHER NEW 20 CM CATHETER, 13.5 FR, HOWEVER, THE SAME SITUATION OCCURS, DIFFERENT SYRINGES ARE USED BOTH 5CC AND 10CC STERILE WITHOUT OBTAINING ADEQUATE FUNCTIONALITY, SO THE PROCEDURE IS SUSPENDED." ADDITIONAL INFORMATION RECEIVED ON MAY 18, 2023: THE PATIENT COULD NOT RECEIVE HIS TREATMENT, DUE TO THE PROBLEM PRESENTED. THIS REPORT ADDRESSES THE FIRST INSERTION ATTEMPT WITH A15 CM CATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17060557 ↗
• MalfunctionMay 10, 2023Contamination /Decontamination Problem; Contamination /Decontamination Problem

  IT WAS REPORTED THAT THE PRODUCT WAS NOT OPENED OR USED. HAIRS WERE SEEN INSIDE THE PACKAGE THROUGH THE TRANSPARENT PACKAGING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16902219 ↗
• MalfunctionApr 13, 2023Material Frayed; Material Frayed

  IT WAS REPORTED BY THE ATTENDING PHYSICIAN THAT "THE METALLIC GUIDE OF THE CATHETER PRESENTS RESISTANCE, THEREFORE IT IS NOT POSSIBLE FOR IT TO PASS, FOR WHICH REASON ANOTHER CATHETER IS REQUESTED." ADDITIONAL INFORMATION RECEIVED ON 06.JAN.2023: RESISTANCE WAS NOTED BEFORE USE ON THE PATIENT. THERE WAS NO PATIENT HARM REPORTED, NO NEED FOR MEDICAL OR SURGICAL INTERVENTION. (B)(6) 2023 - THE RETURNED SAMPLE EXHIBITED A BREAK IN THE COIL WIRE OF THE GUIDEWIRE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16740412 ↗
• MalfunctionDec 29, 2022Material Deformation; Material Deformation

  IT WAS REPORTED, "THE PATIENT WAS ADMITTED TO OUR DEPARTMENT ON (B)(6) 2022 DUE TO PERSISTENT UPPER ABDOMINAL PAIN FOR 3 DAYS. HE WAS DIAGNOSED WITH ACUTE PANCREATITIS, ACUTE RESPIRATORY FAILURE, AND ACUTE RENAL FAILURE. AT 22:00 ON NOVEMBER 30, HE UNDERWENT FEMORAL VEIN PUNCTURE AND CATHETERIZATION. FOR DIALYSIS CATHETERS, THERE ARE MANY DISCOUNTS AND BENDS IN THE GUIDE WIRE DURING THE OPERATION, WHICH MAKES IT DIFFICULT TO PULL OUT THE GUIDE WIRE AND PLACE THE DIALYSIS CATHETER, AND THE PATIENT'S BLEEDING INCREASES, WHICH INCREASES THE DIFFICULTY AND RISK OF THE OPERATION."

  Patient problems: Exsanguination

  MAUDE report 16075125 ↗
• MalfunctionNov 29, 2022Defective Component; Defective Component

  IT WAS REPORTED THAT ON (B)(6), 2022, FEMORAL VEIN PUNCTURE CATHETERIZATION WAS PERFORMED. DURING THE OPERATION, THE DIALYSIS CATHETER WAS BENT AND BROKEN, WHICH MADE IT IMPOSSIBLE TO PERFORM PUNCTURE CATHETERIZATION NORMALLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15878539 ↗
• MalfunctionSep 29, 2022Material Frayed; Material Frayed

  IT WAS REPORTED THAT RESISTANCE WAS ENCOUNTERED WHEN THE GUIDE WIRE WAS BEING REMOVED. AFTER THE GUIDE WIRE WAS REMOVED COMPLETELY, THE HELIX PART OF THE GUIDE WIRE WAS DETACHED FOR 20 CM .ULTRASOUND EXAMINATION WAS CONDUCTED SUBSEQUENTLY TO RULE OUT ANY RESIDUAL OF THE GUIDE WIRE IN THIS PATIENT. IT WAS REPORTED THIS OCCURRED WITH TWO DEVICES. THIS REPORT ADDRESSES THE SECOND DEVICE. ADDITIONAL INFORMATION RECEIVED: WAS THERE ANY PATIENT HARM REPORTED? NO. WERE ANY BROKEN PIECES LEFT INSIDE THE PATIENT? NO PIECES LEFT INSIDE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15501301 ↗
• MalfunctionSep 29, 2022Material Frayed; Material Frayed

  IT WAS REPORTED THAT RESISTANCE WAS ENCOUNTERED WHEN THE GUIDE WIRE WAS BEING REMOVED. AFTER THE GUIDE WIRE WAS REMOVED COMPLETELY, THE HELIX PART OF THE GUIDE WIRE WAS DETACHED FOR 20 CM .ULTRASOUND EXAMINATION WAS CONDUCTED SUBSEQUENTLY TO RULE OUT ANY RESIDUAL OF THE GUIDE WIRE IN THIS PATIENT. IT WAS REPORTED THIS OCCURRED WITH TWO DEVICES. THIS REPORT ADDRESSES THE FIRST DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15501091 ↗
• InjuryJul 29, 2022Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT WHEN THE CATHETER WAS PAUSED, UNDER ULTRASOUND, THE DOCTOR HAD DIFFICULTY INTRODUCING THE CATHETER INTO THE JUGULAR DESPITE CORRECT DILATION. HE USED ANOTHER CATHETER FROM THE SAME LOT, THE PATIENT HAS A JUGULAR HEMATOMA. BOTH DEVICES WERE DISCARDED AFTER EVENT. ADDITIONAL INFORMATION RECEIVED 7/11/22: IT WAS REPORTED BY HEALTHCARE PROFESSIONAL ¿THE HEMATOMA OCCURRED WHEN THE KIT WAS ATTEMPTED DESPITE PLACEMENT UNDER ECHO AND OPTIMAL DILATION WITH, I THINK, A KIT THAT HAD TO GO PARTLY SUBCUTANEOUSLY. SO THE HEMATOMA IS CONSECUTIVE TO THE INSTALLATION OF THE KIT AND PREVENTED THE INSTALLATION OF ANOTHER KIT IN THE SAME PLACE. IT WAS REPORTED THIS OCCURRED WITH TWO DEVICES. THIS REPORT ADDRESSES THE SECOND DEVICE.

  Patient problems: Hematoma

  MAUDE report 15136461 ↗
• InjuryJul 29, 2022Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT WHEN THE CATHETER WAS PAUSED, UNDER ULTRASOUND, THE DOCTOR HAD DIFFICULTY INTRODUCING THE CATHETER INTO THE JUGULAR DESPITE CORRECT DILATION. HE USED ANOTHER CATHETER FROM THE SAME LOT, THE PATIENT HAS A JUGULAR HEMATOMA. BOTH DEVICES WERE DISCARDED AFTER EVENT. ADDITIONAL INFORMATION RECEIVED 7/11/22: IT WAS REPORTED BY HEALTHCARE PROFESSIONAL ¿THE HEMATOMA OCCURRED WHEN THE KIT WAS ATTEMPTED DESPITE PLACEMENT UNDER ECHO AND OPTIMAL DILATION WITH, I THINK, A KIT THAT HAD TO GO PARTLY SUBCUTANEOUSLY. SO THE HEMATOMA IS CONSECUTIVE TO THE INSTALLATION OF THE KIT AND PREVENTED THE INSTALLATION OF ANOTHER KIT IN THE SAME PLACE. IT WAS REPORTED THIS OCCURRED WITH TWO DEVICES. THIS REPORT ADDRESSES THE FIRST DEVICE.

  Patient problems: Hematoma

  MAUDE report 15136150 ↗
• MalfunctionMay 27, 2022Component Incompatible; Material Frayed; Component Incompatible; Material Frayed

  IT WAS REPORTED DOCTOR REPORTED A FAULTY GUIDE WIRE. THE FAULTY GUIDE WIRE GOT STUCK DURING THE PROCEDURE AND THE DOCTOR WAS UNABLE TO ADVANCE IT FORWARD, ALSO EXPERIENCED DIFFICULTY REMOVING IT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14522483 ↗
• MalfunctionMay 26, 2022Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THE PATIENT WAS ADMITTED TO THE HOSPITAL DUE TO ABDOMINAL PAIN FOR 10 HOURS. IN ORDER TO CARRY OUT BLOOD PURIFICATION TREATMENT SMOOTHLY, FEMORAL VEIN PUNCTURE WAS PERFORMED AT 21:30 ON (B)(6) 2022. DURING THE OPERATION, THE GUIDE WIRE WAS BENT IN MANY PLACES, RESULTING IN THE FAILURE OF THE DIALYSIS CATHETER TO PENETRATE THE FEMORAL VEIN SMOOTHLY.

  Patient problems: Pain

  MAUDE report 14518729 ↗
• MalfunctionMar 25, 2022Material Frayed; Material Frayed

  IT WAS REPORTED "HE WAS ADMITTED TO THE HOSPITAL DUE TO 'DISCOVERY OF YELLOW DISCOLORATION OF THE SKIN AND SCLERA WITH UNCONSCIOUSNESS FOR 17 HOURS'. DIAGNOSIS: LIVER FAILURE, FEMORAL VEIN PUNCTURE AND CATHETERIZATION WERE GIVEN ACCORDING TO THE NEEDS OF THE CONDITION. DURING THE PATIENT'S FEMORAL VEIN PUNCTURE AND CANNULATION AT AROUND 20:00 ON (B)(6), 2022, THE GUIDE WIRE WAS DISCOUNTED IN MANY PLACES, WHICH SERIOUSLY AFFECTED THE SURGICAL OPERATION AND CAUSED MORE BLEEDING AT THE PUNCTURE SITE. TREATMENT: OPEN THE GUIDE WIRE IN THE DISPOSABLE STERILE CENTRAL VENIPUNCTURE BAG, CONTINUE THE OPERATION, AND SUCCESSFULLY COMPLETE THE OPERATION (FEMORAL VEIN CATHETERIZATION)".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13904765 ↗
• MalfunctionJul 2, 2021Material Deformation; Material Deformation

  IT REPORTED THE PATIENT WAS ADMITTED TO THE HOSPITAL FOR "RECURRENT FEVER FOR 1 MONTH, NAUSEA, VOMITING, AND ACID REFLUX FOR 1 DAY". THE PATIENT UNDERWENT FEMORAL VEIN PUNCTURE CATHETERIZATION ON (B)(6) 2021. DURING THE OPERATION, IT WAS FOUND THAT THE GUIDE WIRE IN THE DIALYSIS CATHETER WAS DIFFICULT TO REMOVE, AND THE DIALYSIS CATHETER WAS TWISTED, WHICH CAUSED HEAVY BLEEDING DURING THE OPERATION. THE DIALYSIS CATHETER WAS REMOVED, AND THE OPERATION AREA WAS PRESSURIZED AND BANDAGED TO STOP BLEEDING. AFTER THE ABOVE TREATMENT, THE OPERATION AREA BLEEDING STOPPED. REPLACE THE SURGICAL SITE AGAIN AND PERFORM FEMORAL VEIN PUNCTURE AND CATHETERIZATION AGAIN.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 12107428 ↗
• MalfunctionJul 1, 2021Suction Problem; Suction Problem

  IT WAS REPORTED THE PATIENT WAS ADMITTED TO THE HOSPITAL ON (B)(6) 2021. HEMODIALYSIS WAS PERFORMED WITH A CATHETER IN THE RIGHT FEMORAL VEIN ON (B)(6) 2021. ON (B)(6) 2021, IT WAS FOUND THAT THE PATIENT'S FEMORAL VEIN DIALYSIS CATHETER DID NOT RETURN BLOOD SMOOTHLY. THE EFFECT OF REPEATED ADJUSTMENTS TO THE CATHETER POSITION WAS NOT EFFECTIVE. THUS, REMOVED AND RE-INSERTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12100688 ↗
• MalfunctionNov 18, 2020Complete Blockage

  IT WAS REPORTED THAT AT 00:56 ON (B)(6) 2020, IT WAS FOUND THAT THE DIALYSIS CATHETER TUBE WAS BLOCKED WHEN PREPARING TO PERFORM DEEP VENIPUNCTURE ON THE PATIENT. AFTER THE TREATMENT, THE TUBE WAS CLEARED. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10864490 ↗
• MalfunctionAug 20, 2020Material Frayed; Material Frayed

  IT WAS REPORTED THE PATIENT HAD LIVER FAILURE AND WAS TREATED WITH BEDSIDE BLOOD PURIFICATION SMOOTHLY. AFTER OBTAINING FAMILY MEMBERS¿ CONSENT AND SIGNING, THE RIGHT FEMORAL VEIN PUNCTURE WAS PERFORMED FOR THE PATIENT AT 16:00 ON (B)(6) 2020. THE GUIDE WIRE WAS FOUND TO BE BROKEN DURING THE OPERATION, THE DIALYSIS CATHETER WAS REPLACED, AND THE RIGHT FEMORAL VEIN PUNCTURE WAS PERFORMED AGAIN CATHETERIZATION. NO EFFECT ON PATIENTS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10433567 ↗
• MalfunctionJul 23, 2020Material Deformation; Material Deformation

  THE DOCTOR REPORTED , ON (B)(6) 2020, THAT WHEN THE PATIENT WAS INFUSED THROUGH THE PERIPHERALLY INTUBATED CENTRAL VENOUS CATHETER, THE SHEATH OF THE DELIVERY CATHETER WAS FOUND TO BE BENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10313745 ↗
• MalfunctionAug 23, 2017Difficult to Remove

  IT WAS REPORTED THAT THE GUIDEWIRE WAS THREADED INTO THE VEIN WITH EASE, THEN THE CATHETER WAS THREADED IN WITHOUT ANY RESISTANCE. WHEN ATTEMPTING TO REMOVE THE GUIDEWIRE THE PHYSICIAN MET RESISTANCE AND THE GUIDEWIRE APPEARED TO BE ONLY STRETCHING. THE PHYSICIAN REMOVED THE ENTIRE CATHETER TO GET THE GUIDEWIRE OUT. PROCEDURE WAS STARTED AGAIN AND THE PHYSICIAN EXPERIENCED THE SAME ISSUE. THE PROCEDURE WAS STOPPED. NO INJURY TO THE PATIENT WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6815165 ↗
• MalfunctionAug 11, 2017Crack

  THE DOCTOR WAS PERFORMING AN ACUTE DIALYSIS CATHETER INSERTION YESTERDAY, USING THE ULTRASOUND. THE DOCTOR REPORTED THE CATHETER WAS INSERTED AND THE FOLLOWING DAY IT HAD CRACKED. THERE WAS SLIGHT BLEEDING. NO PATIENT INJURY WAS REPORTED.

  Patient problems: Blood Loss

  MAUDE report 6788500 ↗
• MalfunctionAug 4, 2017Material Deformation

  IT WAS REPORTED THAT THE GUIDE OF 2 NIAGARA CATHETER STAY BLOCKED IN THE NEEDLE THEN DEFORMED "TO SHRINKAGE" AT THE TIME OF REMOVAL. THIS FILE ADDRESS THE SECOND CATHETER. ON 07/12/2017- EVALUATION FOUND DAMAGED DILATOR TIPS. NO DAMAGE TO GUIDEWIRE NOTED. HM

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6769104 ↗