Niagara catheter 5593240Recalls & reported problems

Summary

The FDA's MAUDE database contains 40 adverse event reports that list this exact device (DI 00801741045585), received between Jan 27, 2016 and May 21, 2026 — classified as 4 injuries, 36 malfunctions.

The most frequently reported specific device problem is “Material Deformation” (16 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 40 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 21, 2026Component Incompatible

  IT WAS REPORTED THAT A PATIENT REQUIRED CONTINUOUS HEMODIALYSIS TREATMENT. WHILE THE ATTENDING PHYSICIAN WAS PLACING A HEMODIALYSIS TUBING IN THE PATIENT¿S LEFT NECK, THE GUIDEWIRE BECAME STUCK AND DID NOT RETRIEVE SMOOTHLY; HOWEVER, BECAUSE IT WAS CONTAMINATED WITH THE PATIENT¿S BLOOD, IT WAS DISCARDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25240947 ↗
• InjuryApr 22, 2026Material Deformation

  IT WAS REPORTED THAT THE PATIENT HAD A RIGHT FEMORAL VENOUS DIALYSIS CATHETER PLACED AT 13:00, AND THE CATHETER WAS DIFFICULT TO PLACE DUE TO THE GUIDEWIRE BEING TOO SOFT AND THE GUIDEWIRE BEING BENT IN MANY PLACES DURING SKIN EXPANSION, WHICH PROLONGED THE TUBING TIME, AND THE PATIENT BLED EXCESSIVELY. NO FURTHER INFORMATION PROVIDED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 24954252 ↗
• MalfunctionMar 2, 2026Material Deformation

  IT WAS REPORTED THAT (B)(6) 2026, 8:40 AM THE PATIENT UNDERWENT HEMODIALYSIS TREATMENT. UNDER ULTRASOUND GUIDANCE, THE CRITICAL CARE PHYSICIAN SLOWLY ADVANCED THE INTRODUCER NEEDLE TOWARD THE UMBILICUS AT A 45-DEGREE ANGLE TO THE SKIN, PERFORMING INTERMITTENT ASPIRATION DURING INSERTION. AFTER ADVANCING APPROXIMATELY 2.0 CM AND ASPIRATING DARK RED BLOOD, A GUIDEWIRE WAS INSERTED. FOLLOWING SUCCESSFUL DILATION WITH A DILATOR FINGER, THE DILATOR FINGER WAS WITHDRAWN. ATTEMPTING TO ADVANCE THE HEMOFILTRATION CATHETER REVEALED DIFFICULT PLACEMENT AND RESISTANCE DURING GUIDEWIRE RETRACTION. ADJUSTMENT ATTEMPTS FAILED, NECESSITATING WITHDRAWAL. THE GUIDEWIRE WAS SEVERELY BENT. IMMEDIATELY SWITCHED TO A DIFFERENT BRAND OF DEEP VENOUS GUIDEWIRE FOR RE-PUNCTURE. THE DEEP VENOUS GUIDEWIRE ALLOWED SUCCESSFUL PUNCTURE, AND THE HEMOFILTRATION CATHETER WAS SUCCESSFULLY PLACED. THE PATIENT WAS SUCCESSFULLY CONNECTED TO THE MACHINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24491873 ↗
• MalfunctionMar 2, 2026Material Deformation

  IT WAS REPORTED THAT ON (B)(6) 2026, 07:30 PATIENT EXHIBITS ELEVATED BILIRUBIN LEVELS, MEETING INDICATIONS FOR ARTIFICIAL LIVER THERAPY. AN INTENSIVE CARE PHYSICIAN PERFORMED ULTRASOUND-GUIDED VENOUS PUNCTURE FOR RIGHT FEMORAL BLOOD FILTRATION CATHETER PLACEMENT. UNDER ULTRASOUND GUIDANCE, THE INTRODUCER NEEDLE WAS ADVANCED SLOWLY AT A 45-DEGREE ANGLE TOWARD THE UMBILICUS WHILE ASPIRATING CONTINUOUSLY. AFTER APPROXIMATELY 2.0 CM OF ADVANCEMENT, DARK RED BLOOD WAS ASPIRATED. A GUIDEWIRE WAS INSERTED FOR ABOUT 25 CM BUT FAILED TO PASS SMOOTHLY. ULTRASOUND CONFIRMED THE INTRODUCER NEEDLE REMAINED WITHIN THE VASCULAR LUMEN. CONSIDERING THE GUIDEWIRE AS THE CAUSE, IT WAS WITHDRAWN AND FOUND TO HAVE A KINK AT THE TIP. IMMEDIATELY REPLACING IT WITH A DIFFERENT BRAND OF DEEP VEIN GUIDEWIRE ALLOWED SUCCESSFUL INSERTION. THE INTRODUCER NEEDLE WAS THEN WITHDRAWN. AFTER SKIN EXPANSION WITH A DILATOR, A 24 CM DUAL-LUMEN HEMODIALYSIS VENOUS CATHETER WAS PLACED, AND THE GUIDEWIRE WAS COMPLETELY WITHDRAWN. THE PROCEDURE CONCLUDED SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24488682 ↗
• MalfunctionFeb 4, 2026Crack

  IT WAS REPORTED THAT DURING USE, THE INTRODUCER NEEDLE EXHIBITED FLUID LEAKAGE AND DREW IN AIR DURING USE. AN ADDITIONAL NEW CATHETER HAD TO BE USED. NO FURTHER DETAILS AVAILABLE OR PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24257718 ↗
• MalfunctionNov 25, 2025Crack; Crack

  IT WAS REPORTED THE PHYSICIAN OBSERVED EXCESSIVE AIR BUBBLES DURING ASPIRATION AFTER THE PUNCTURE, SUSPECTING ENTRY INTO THE PLEURAL CAVITY. THE NEEDLE WAS IMMEDIATELY WITHDRAWN. SUBSEQUENT REPEATED ASPIRATIONS YIELDED AIR BUBBLES, NECESSITATING MULTIPLE NEEDLE WITHDRAWALS, ULTIMATELY RESULTING IN A FAILED PUNCTURE. UPON CLOSE INSPECTION OF THE GUIDE NEEDLE, A CRACK WAS FOUND AT THE NEEDLE STOPPER. A TEST ASPIRATION REVEALED THAT THE BUBBLES WERE CAUSED BY THIS CRACK. CONSEQUENTLY, THE SYRINGE HAD A DEFECT, CAUSING AIR LEAKAGE AND DIFFICULTY IN ASPIRATING FLUID. THE CANNULATION SET WAS THEREFORE DISCARDED. THIS ISSUE DIRECTLY RESULTED IN THE SCRAPPING OF THE NEWLY ESTABLISHED CANNULATION. IT WAS REPORTED THIS OCCURRED WITH TWO DEVICES. THIS REPORT ADDRESSES BOTH DEVICES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23646686 ↗
• MalfunctionNov 25, 2025Product Quality Problem; Product Quality Problem

  IT WAS REPORTED ON (B)(6) 2025, THE DOCTOR MADE ROUNDS TO ASSESS THE NEED FOR BEDSIDE CRRT TREATMENT, AND FEMORAL VEIN CRRT CATHETERIZATION WAS PERFORMED. AT 09:30 ON (B)(6) 2025, THE ULTRASOUND WAS GUIDED IN REAL TIME, THE ANESTHESIA WAS SATISFACTORY, THE PUNCTURE POSITIONING WAS CARRIED OUT SMOOTHLY, AND THE DARK RED BLOOD COULD BE SUCCESSFULLY WITHDRAWN, BUT IN THE GUIDE WIRE FEEDING LINK, THE GUIDE WIRE WAS EXTREMELY UNSMOOTH, IN ORDER TO AVOID VASCULAR DAMAGE TO THE PATIENT, THE PUNCTURE NEEDLE WAS PULLED OUT TOGETHER WITH THE GUIDEWIRE, AND LOCAL PRESSURE WAS APPLIED TO STOP THE BLEEDING. LATER, IT WAS FOUND THAT THE GUIDEWIRE WAS EMBEDDED IN THE NEEDLE TUBE AND COULD NOT MOVE FORWARD OR BACKWARD. CONSIDERING THE MISMATCH BETWEEN THE GUIDEWIRE AND THE NEEDLE TUBE, THE CRRT PUNCTURE PACKAGE IS REOPENED, THE GUIDEWIRE IS MATCHED WITH THE NEEDLE TUBE, THE PUNCTURE IS SMOOTH, AND THE PATIENT CAN PROCEED WITH CRRT TREATMENT SMOOTHLY. THIS EVENT CAUSED THE PATIENT TO UNDERGO A SECOND PUNCTURE, RESULTING IN LOCAL VASCULAR DAMAGE. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23646668 ↗
• MalfunctionNov 4, 2025Material Deformation; Material Deformation

  IT WAS REPORTED WHEN ATTEMPTING TO INSERT THE DILATOR AFTER INCISION AT THE PUNCTURE SITE, THE GUIDEWIRE KINKED (OR, ALTERNATIVELY, WHILE DILATOR INSERTION PROCEEDED SMOOTHLY, THE CATHETER COULD NOT ADVANCE DUE TO GUIDEWIRE KINKING DURING CATHETER PLACEMENT). THE PHYSICIAN IMMEDIATELY SWITCHED TO A GUIDEWIRE FROM A DIFFERENT DISPOSABLE STERILE CENTRAL VENOUS CATHETER TO COMPLETE THE PLACEMENT. IT WAS REPORTED THIS OCCURRED WITH FIVE DEVICES. THIS REPORT ADDRESSES ALL FIVE DEVICES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23467208 ↗
• MalfunctionNov 4, 2025Material Deformation; Material Deformation

  IT WAS REPORTED PATIENT WITH RENAL INSUFFICIENCY, UREMIA, OR HYPERKALEMIA REQUIRE HEMODIALYSIS TREATMENT. DURING ULTRASOUND-GUIDED CATHETER PLACEMENT, THE PHYSICIAN SUCCESSFULLY PERFORMED THE PROCEDURE WITH ADEQUATE BLOOD RETURN AND SMOOTH GUIDEWIRE PLACEMENT. HOWEVER, WHEN ATTEMPTING TO INSERT THE DILATOR AFTER INCISION AT THE PUNCTURE SITE, THE GUIDEWIRE KINKED (OR, ALTERNATIVELY, WHILE DILATOR INSERTION PROCEEDED SMOOTHLY, THE CATHETER COULD NOT ADVANCE DUE TO GUIDEWIRE KINKING DURING CATHETER PLACEMENT). THE PHYSICIAN IMMEDIATELY SWITCHED TO A GUIDEWIRE FROM A DIFFERENT DISPOSABLE STERILE CENTRAL VENOUS CATHETER TO COMPLETE THE PLACEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23467203 ↗
• MalfunctionSep 16, 2025Material Deformation; Material Deformation

  IT WAS REPORTED DURING PLACEMENT OF THE SHORT TRANSLUMINAL CATHETER 5593240, THE GUIDEWIRE COILED, RESULTING IN CLINICAL FEEDBACK THAT IT COULD NOT BE USED NORMALLY. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23064464 ↗
• MalfunctionAug 12, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THE DIALYSIS MACHINE (FRESENIUS MULTIFILTRATE) REGULARLY GAVE AN AIR ALARM. IT WAS OBVIOUSLY DRAWING AIR. THIS WAS EVIDENT FROM THE MACHINE'S BUBBLE TRAP. THE DIALYSIS DEPARTMENT WAS ALSO CONSULTED. THE CATHETER WAS ALSO VISUALLY INSPECTED SEVERAL TIMES; NO MACROSCOPIC ABNORMALITIES COULD BE DETECTED. ON (B)(6) 2025, IT WAS DECIDED TO CHANGE THE DIALYSIS CATHETER. ASERVATION OF IT. I EXAMINED THE CATHETER BY CLASSIC "SQUEEZING"; SALINE WAS DRIPPING FROM THE TRANSITION FROM THE HUB TO THE INTRAVASCULAR PART OF THE CATHETER. THIS WOULD EXPLAIN THE DRAWING OF AIR. THE NIAGARA CATHETER WAS USED ON THE PATIENT IN THE PERIOD FROM (B)(6) 2025. NO ADDITIONAL MEDICAL INTERVENTION/MEDICATION WAS REQUIRED. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22787118 ↗
• MalfunctionApr 30, 2025Material Deformation; Material Deformation

  IT WAS REPORTED; THE SMALL DILATOR WAS DAMAGED AT THE END AND TWISTED BEFORE USE. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21938692 ↗
• MalfunctionFeb 4, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED, AN INCIDENT WHICH OCCURRED ON (B)(6)2024 CONCERNING A NIAGARA HIGH FLOW CATHETER FOR HEMODIALYSIS WITH COMMERCIAL REFERENCE (B)(4). IT CONCERNS A PATIENT UNDERGOING DIALYSIS. THE PATIENT HAD A FEMORAL CATHETER. WHEN UNCLAMPING THE ARTERIAL LINE, BLOOD LEAKED FROM THE TUBING UNDER THE CLAMP. TUBING UNDER THE CLAMP. THE NURSE IMMEDIATELY RE-CLAMPED AND CALLED THE DOCTOR. THE CATHETER WAS REPLACED BY CATHETER OF THE SAME COMMERCIAL REFERENCE. NO CLINICAL CONSEQUENCES FOR THE PATIENT. LEAKAGE DUE TO RAPID RE-CLAMPING. NO COMPLICATIONS DURING THE DIALYSIS SESSION. THIS IS NOT A RECURRING PROBLEM. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 21309597 ↗
• MalfunctionFeb 2, 2024Material Deformation; Material Deformation

  IT WAS REPORTED BY THE CUSTOMER "ON (B)(6) 2023, DURING THE PROCESS OF HEMOFILTRATION CATHETER PUNCTURE, THE PATIENT HAD NO DISINFECTANT ITEMS, SEAMLESS THREAD ITEMS, AND NO STERILE TREATMENT WIPES IN THE DIALYSIS CATHETER TO FORM A STERILE BARRIER, AND AFTER THE PUNCTURE NEEDLE PIERCED THE SKIN, THE GUIDEWIRE COULD NOT ENTER ALONG THE SYRINGE, NOR COULD THE GUIDEWIRE BE WITHDRAWN, RESULTING IN THE PUNCTURE PROCESS COULD NOT BE COMPLETED SMOOTHLY. AFTER REPLACING THE NEW CONSUMABLE, RE-PUNCTURE IS PERFORMED TO COMPLETE THE OPERATION SMOOTHLY." NO OTHER INFORMATION WAS PROVIDED. (B)(6) 2024 ONE GUIDEWIRE WAS RETURNED FOR EVALUATION AND WAS FOUND TO BE KINKED IN MULTIPLE PLACES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18632609 ↗
• MalfunctionSep 15, 2023Material Frayed; Defective Component; Material Frayed; Defective Component

  CUSTOMER REPORTS THAT CONTINUOUS RENAL REPLACEMENT THERAPY TREATMENT WAS PERFORMED ON THE PATIENT'S QUASI-PUNCTURE FEMORAL VEIN HEMOFILTRATION CATHETER. DURING THE PUNCTURE, THE GUIDE WIRE WAS BROKEN AND A NEW DIALYSIS CATHETER WAS USED. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17752988 ↗
• MalfunctionSep 7, 2023Material Deformation; Material Deformation

  IT WAS REPORTED THAT THE COMPLAINT OF TWO CASES OF THE INTRODUCER SHEATH BEING PRONE TO DEFORMATION DURING PLACEMENT OF THE SHORT-TERM DIALYSIS CATHETER. NO OTHER INFORMATION WAS PROVIDED. THIS REPORT ADDRESSES THE SECOND DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17698432 ↗
• MalfunctionSep 7, 2023Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT THE COMPLAINT OF TWO CASES OF THE GUIDE WIRE WAS PRONE TO KINK DURING PLACEMENT OF THE SHORT-TERM DIALYSIS CATHETER. NO OTHER INFORMATION WAS PROVIDED. THIS REPORT ADDRESSES THE SECOND DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17698430 ↗
• MalfunctionSep 7, 2023Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT THE COMPLAINT OF TWO CASES OF THE GUIDE WIRE WAS PRONE TO KINK DURING PLACEMENT OF THE SHORT-TERM DIALYSIS CATHETER. NO OTHER INFORMATION WAS PROVIDED. THIS REPORT ADDRESSES THE FIRST DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17698426 ↗
• MalfunctionSep 7, 2023Material Deformation; Material Deformation

  IT WAS REPORTED THAT THE COMPLAINT OF TWO CASES OF THE INTRODUCER SHEATH BEING PRONE TO DEFORMATION DURING PLACEMENT OF THE SHORT-TERM DIALYSIS CATHETER. NO OTHER INFORMATION WAS PROVIDED. THIS REPORT ADDRESSES THE FIRST DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17698424 ↗
• InjuryAug 22, 2023Component Incompatible; Component Incompatible

  IT WAS REPORTED, "ON (B)(6) 2023 A RIGHT FEMORAL DIALYSIS CATHETER WAS INSERTED IN THE PATIENT. DIFFICULT INSERTION AS THERE WAS A PROBLEM INSERTING THE GUIDE. INSTRUCTIONS TO MONITOR THE CATHETER DURING DIALYSIS: NO WORRIES FOUND DIALYSIS EFFECTIVE/PATIENT DEGLOBULATES TRANSFUSION/ BUT ON (B)(6) 2023 APPEARANCE OF A HEMATOMA IN THE THIGH SCANNER SHOWS A RETROPERITONEAL COLLECTION. RESULTED IN BODILY INJURY, MATERIAL DAMAGE, PSYCHOLOGICAL DAMAGE, MATERIAL WASTE, DISSATISFACTION, LOSS OF TIME."

  Patient problems: Hematoma

  MAUDE report 17597389 ↗
• MalfunctionAug 21, 2023Material Deformation; Material Deformation

  IT WAS REPORTED THAT IN ORDER TO PERFORM CRRT TREATMENT, CATHETERIZATION OF THE RIGHT FEMORAL VEIN WAS PERFORMED ON (B)(6) 2023. GUIDE WIRE WAS INSERTED DURING THE PUNCTURE PROCESS, BUT THE GUIDE WIRE WAS BENT AFTER THE SKIN EXPANSION AND THE SKIN EXPANSION NEEDLE WAS SPLIT, RESULTING IN CATHETER INSERTION FAILURE. FINALLY, THE LEFT FEMORAL VEIN PUNCTURE WAS PERFORMED. AFTER INITIAL SKIN EXPANSION WITH DOUBLE CAVITY DEEP VENIPUNCTURE GUIDE WIRE AND DIFFUSER NEEDLE, BARD DIFFUSER NEEDLE WAS USED TO COMPLETE THE OPERATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17585000 ↗
• MalfunctionJul 24, 2023Material Twisted/Bent; Material Twisted/Bent

  CUSTOMER REPORTED THE PATIENT UNDERWENT BLOOD PURIFICATION TREATMENT WITH FEMORAL VEIN HEMOFILTRATION CATHETER PUNCTURE AND CATHETERIZATION UNDER COLOR ULTRASOUND POSITIONING. THE GUIDE WIRE WAS DISCOUNTED DURING THE CATHETERIZATION PROCESS. REPLACING THE GUIDE WIRE AND PLACING THE TUBE AGAIN DELAYS TREATMENT AND MAY CAUSE SERIOUS INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17385735 ↗
• MalfunctionMay 25, 2023Defective Component; Material Twisted/Bent; Defective Component; Material Twisted/Bent

  IT WAS REPORTED BY THE CUSTOMER THAT WHEN USING DIALYSIS CATHETER FOR PATIENTS WITH CARDIOPLASMIC SHOCK SEPSIS, THE GUIDE WIRE WAS BENT IN MANY PLACES AND THE TIP OF THE SHEATH WAS EASILY BROKEN. NO PATIENT HARM REPORTED, NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17002391 ↗
• MalfunctionJan 24, 2023Material Frayed; Material Frayed

  IT WAS REPORTED BY THE CUSTOMER "THE DIALYSIS CATHETER GUIDE GOT STUCK IN THE PUNCTURE NEEDLE. THE INTERN COULD NEITHER PUSH NOR PULL IT OUT. IT GOT STUCK IN THE BEVEL OF THE NEEDLE. AS A RESULT, THE GUIDE AND DILATOR WERE REMOVED AND THE PROCEDURE HAD TO BE PERFORMED AGAIN." 1/9/2023 - FOUND DURING EVALUATION, THE GUIDEWIRE WAS BROKEN WHICH ALLOWED THE OUTER COIL WIRE TO BECOME UNRAVELED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16233429 ↗
• MalfunctionDec 15, 2022Material Deformation; Material Deformation

  IT WAS REPORTED BY HEALTHCARE PROFESSIONAL AT AROUND 23:30 ON (B)(6) 2022, THE PATIENT WAS TREATED IN THE ICU OF OUR HOSPITAL DUE TO SEVERE LIVER FAILURE AND RENAL FAILURE. WHEN THE CATHETER WAS INSERTED, THE GUIDE WIRE COULD NOT PASS THROUGH, AND AFTER DETAILED INSPECTION, IT WAS FOUND THAT THE CATHETER HAD A NARROW CREASE THAT PREVENTED THE GUIDE WIRE FROM PASSING. THEN THE NURSE IMMEDIATELY REPLACED ANOTHER DIALYSIS CATHETER PACKAGE FOR THE PATIENT, FOUND IT IN TIME, HANDLED IT QUICKLY, AND DID NOT CAUSE SUBSTANTIAL HARM TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15992607 ↗