Niagara catheter 5593200Recalls & reported problems

Summary

The FDA's MAUDE database contains 53 adverse event reports that list this exact device (DI 00801741045578), received between Jul 28, 2016 and Feb 11, 2026 — classified as 3 injuries, 50 malfunctions.

The most frequently reported specific device problem is “Material Deformation” (14 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 53 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 11, 2026Material Deformation

  IT WAS REPORTED BY THE CUSTOMER THAT THE VENOUS GUIDE CORE OF THE CATHETER HAD A KINK, WHICH PREVENTED THE GUIDEWIRE FROM PASSING THROUGH THE DEVICE. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Insufficient Information

  MAUDE report 24312840 ↗
• MalfunctionFeb 10, 2026Crack

  IT WAS REPORTED BY THE CUSTOMER THAT THE PORT AT THE NEEDLE TIP CRACKED. WHEN THE DEVICE WAS CONNECTED TO A SYRINGE UNDER NEGATIVE PRESSURE, LEAKAGE WAS DETECTED. THIS REPORT ADDRESSES ONE DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24308306 ↗
• MalfunctionJan 26, 2026Component Incompatible

  IT WAS REPORTED THAT DURING USE OF THE CATHETER THE GUIDEWIRE COULD BE ADVANCED BUT THE INTRODUCER NEEDLE COULD NEITHER BE ADVANCED NOR WITHDRAWN, PREVENTING SUCCESSFUL CATHETER PLACEMENT. NO FURTHER DETAILS AVAILABLE OR PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24182591 ↗
• MalfunctionOct 30, 2025Contamination /Decontamination Problem; Contamination /Decontamination Problem

  IT WAS REPORTED PIECE OF PLASTIC PRESENT IN A LUMEN. THE FRAGMENT WAS IDENTIFIED AFTER ASPIRATION ON THE ARTERIAL LUMEN. THERE WAS AN ISSUE WITH ASPIRATION IN FIRST INSTANCE. WHEN PERSISTING A PIECE OF PLASTIC (THE FRAGMENT) WAS ASPIRATED IN THE SYRINGE. IT WAS DISCOVERED AFTER PLACING THE CATHETER IN THE VEIN. UPON PREPARATION THERE WAS NO APPARENT PROBLEM WITH THE CATHETER. THERE WAS NO CLEAR IMPACT ON THE PATIENT, AN X-RAY WAS DONE TO IDENTIFY ANY OTHER FRAGMENTS, OF WHICH NONE WAS APPARENT. THERE WAS NO CLINICAL IMPACT FOR THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23424500 ↗
• MalfunctionSep 5, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT AT 10:00 ON (B)(6) 2025, WHEN A DIALYSIS TUBE WAS INSERTED INTO A PATIENT, WATER LEAKED FROM THE CONNECTION OF THE CANNULA, AFFECTING THE DIALYSIS EFFECT AND DELAYING THE TREATMENT PROCESS. AFTER THE LEAK OCCURRED, THE MEDICAL STAFF DEALT WITH IT IN A TIMELY MANNER, READJUSTED THE CONNECTION, AND REPLACED THE CATHETER OR CANNULA.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22983575 ↗
• MalfunctionJun 3, 2025Component Incompatible; Component Incompatible

  IT WAS REPORTED WHEN USING THE BARD CATHETER IT WAS FOUND THAT THERE WAS A PROBLEM WITH THE GUIDEWIRE, THE GUIDEWIRE WAS BENT, IT COULD NOT BE PULLED OUT FROM THE CANNULA, AND IT COULD NOT BE USED. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22136625 ↗
• MalfunctionMay 6, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT BEFORE USING THE CATHETER, IT WAS FOUND THAT THE TUBING SUPPLIES WERE FRACTURED AND COULD NOT BE USED. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21973675 ↗
• MalfunctionApr 26, 2025Material Deformation; Material Deformation

  IT WAS REPORTED THAT THE PATIENT WAS ADMITTED TO ICU DUE TO SEPSIS. AS THE PATIENT'S CONDITION WAS SERIOUS AND NEEDED HEMODIALYSIS TREATMENT, THE DOCTOR USED THE CATHETER TO PLACE IT INTO THE RIGHT FEMORAL VEIN FOR THE PATIENT AT THE BEDSIDE AT 13:30, AND THE GUIDEWIRE WAS NOT SMOOTH WHEN HE PULLED IT OUT AFTER PLACING THE CATHETER. AFTER REPEATEDLY ADJUSTING THE POSITION AND PULLING IT OUT, HE FOUND THAT THE GUIDEWIRE HAD BEEN FOLDED INSIDE THE BODY, AND THEN HE IMMEDIATELY REPLACED THIS CATHETER AND RELOCATED THE CATHETER TO CARRY OUT THE NEXT STEP OF THE TREATMENT FOR THE PATIENT. THE PATIENT'S CONDITION WILL BE MONITORED CONTINUOUSLY. THERE WERE NO PIECES RETAINED IN THE PATIENT AND NO INTERVENTION REQUIRED. NO FURTHER INFORMATION PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21915522 ↗
• MalfunctionApr 21, 2025Material Deformation; Material Deformation

  IT WAS REPORTED, BENT AND KINKING OF THE GUIDEWIRE DURING USE. ADDITIONAL INFORMATION RECEIVED: CATHETER WAS NOT PLACED SUCCESSFULLY. NEW GUIDEWIRE WAS NOT REQUIRED TO PLACE CATHETER. EVENT CAUSED PROLONGED PROCEDURE. NO PATIENT HARM. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21873071 ↗
• MalfunctionOct 30, 2024Material Deformation; Material Deformation

  IT WAS REPORTED ON (B)(6) 2024, WHEN THE PHYSICIAN WAS LEAVING A DIALYSIS CATHETER IN PLACE AT THE PATIENT'S BEDSIDE, HE FOUND THAT THERE WAS A QUALITY PROBLEM WITH THE SUPPLIES USED (THE FRONT OF THE FLARING SHEATH WAS ROUGHLY MADE AND BENT, MAKING IT IMPOSSIBLE TO PLACE THE CATHETER SMOOTHLY), AND HE IMMEDIATELY REPLACED IT WITH A NEW SUPPLY AND RE-INSTATED THE PATIENT'S DIALYSIS CATHETER. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20569251 ↗
• MalfunctionSep 26, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED, ON (B)(6) 2024, A NURSE RUPTURED THE PUNCTURE NEEDLE AND NEEDLE CONNECTOR INTERFACE DURING THE OPERATION OF DIALYSIS TREATMENT FOR A PATIENT, RESULTING IN A SMALL AMOUNT OF BLOOD SEEPAGE. THE NURSE THEN REPLACED THE PATIENT WITH A NEW DIALYSIS CATHETER AND RE-PUNCTURED THE PATIENT WITH INCREASED DISCOMFORT. NO OTHER ADVERSE EVENTS WERE CAUSED TO THE PATIENT. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: Discomfort; Hemorrhage/Blood Loss/Bleeding

  MAUDE report 20310102 ↗
• MalfunctionSep 6, 2024Material Deformation; Material Deformation

  IT WAS REPORTED, ON (B)(6) 2024, THE HEMODIALYSIS CENTRE HAD RESISTANCE TO DELIVERING A GUIDEWIRE DURING THE PLACEMENT OF A CATHETER IN A PATIENT, AND AFTER ADJUSTMENTS WERE MADE IT WAS STILL DIFFICULT TO DELIVER THE GUIDEWIRE, AND THE TIP OF THE GUIDEWIRE WAS FOUND TO BE BENT WHEN THE GUIDEWIRE WAS WITHDRAWN, AND A NEW CATHETER WAS PLACED. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20164093 ↗
• MalfunctionJul 18, 2024Crack; Crack

  IT WAS REPORTED A TEMPORARY FEMORAL VEIN LINE FOR DIALYSIS WAS PLACED IN THE PATIENT AT 15:30 ON (B)(6) 2024. DURING THE PLACEMENT PROCESS, THE PUNCTURE NEEDLE WAS FOUND TO BE UNEVEN WITH BURRS, AND THE NEEDLE HANDLE LEAKED DURING THE PUNCTURE, WHICH RESULTED IN AN INABILITY TO SUCCESSFULLY PUNCTURE THE PATIENT, SO THE PATIENT HAD TO OPEN UP ANOTHER SET OF PLACEMENT SUPPLIES TO RE-LOCATE THE LINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19777415 ↗
• MalfunctionJun 17, 2024Material Deformation; Material Deformation

  IT WAS REPORTED, IN THE PROCESS OF USING THE CATHETER, IT WAS DIFFICULT TO WITHDRAW THE NEEDLE. NO OTHER INFORMATION WAS PROVIDED. IT WAS REPORTED THIS OCCURRED WITH TWO DEVICES. THIS REPORT ADDRESSES THE SECOND DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19548326 ↗
• MalfunctionJun 17, 2024Material Deformation; Material Deformation

  IT WAS REPORTED, IN THE PROCESS OF USING THE CATHETER, IT WAS DIFFICULT TO WITHDRAW THE NEEDLE. NO OTHER INFORMATION WAS PROVIDED. IT WAS REPORTED THIS OCCURRED WITH TWO DEVICES. THIS REPORT ADDRESSES THE FIRST DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19548323 ↗
• MalfunctionMay 2, 2024Component Incompatible; Material Deformation; Component Incompatible; Material Deformation

  IT WAS REPORTED FACILITY HAD ONE CASE OF SHORT DIMETIC CIR THIS WEEK, MAINLY BECAUSE WHEN THE GUIDEWIRE WAS PUSHED HALFWAY THROUGH USE, IT COULD NOT BE SENT IN OR PULLED OUT. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19235622 ↗
• InjuryMay 1, 2024Material Frayed; Material Frayed

  IT WAS REPORTED, ¿ON 03/03/2024, CONCERNING A DIALYSIS CATHETER WITH COMMERCIAL REFERENCE (B)(4) AND LOT NUMBER REGU2215. PATIENT REQUIRING EXTRA-RENAL PURIFICATION. WHEN THE NURSE OPENED THE DIALYSIS CATHETER, THE PACKAGING WAS NOT SOILED, DAMAGED OR OUT-OF-DATE. DURING INSERTION, THE PHYSICIAN FELT RESISTANCE WHEN INSERTING THE GUIDE. HE TRIED TO PULL IT OUT BUT WAS UNABLE TO DO SO. THE GUIDE IS STUCK. AFTER SEVERAL ATTEMPTS, HE MANAGES TO PULL IT OUT, BUT THE GUIDE IS NO LONGER RIGID, IT'S LIKE AN ACCORDION: IT'S COME OUT COMPLETELY RELAXED. THE PATIENT SUFFERED A DELAY IN HIS PURIFICATION AND A HEMATOMA. PATIENT ALREADY HAD SERIOUS HEMOSTASIS PROBLEMS. THE DEPARTMENT THEREFORE TOOK ANOTHER CATHETER AND INSERTED IT VIA THE FEMORAL ROUTE, WITHOUT ANY COMPLICATIONS.¿ NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: Hematoma

  MAUDE report 19220231 ↗
• MalfunctionNov 15, 2023Failure to Infuse; Failure to Infuse

  IT WAS REPORTED ON (B)(6) 2023 THE PRESSURE AT THE VENOUS END OF THE DIALYSIS CATHETER INCREASED DURING THE DIALYSIS PROCESS, AND THE FLOW RATE WAS BETTER AFTER UROKINASE THROMBOLYSIS AND SEALING TREATMENT. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18139041 ↗
• MalfunctionOct 26, 2023Material Frayed; Material Deformation; Material Frayed; Material Deformation

  IT WAS REPORTED BY THE CUSTOMER "STANDARD ULTRASOUND-GUIDED PUNCTURE OF THE VESSEL AND INSERTION OF THE WIRE. THIS CAN BE ADVANCED SO FAR THAT THE TIP OF THE WIRE IS CERTAINLY IN THE VESSEL, THEN SUDDENLY NO MORE ADVANCEMENT AND RETRACTION POSSIBLE, WIRE AS IF "BLOCKED". TURNING OR CHANGING THE POSITION OF THE NEEDLE DOES NOT HELP. FINALLY, WIRE AND NEEDLE ARE PULLED OUT OF THE VESSEL TOGETHER RESULTED IN NEW PUNCTURE OF THE PATIENT; DELAYED CATHETER INSERTION; POTENTIAL VESSEL DAMAGE, BECAUSE BENT WIRE TIP COULD NOT BE PULLED BACK INTO NEEDLE". NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18013763 ↗
• MalfunctionOct 18, 2023Material Frayed; Material Deformation; Material Frayed; Material Deformation

  IT WAS REPORTED BY THE CUSTOMER "STANDARD ULTRASOUND-GUIDED PUNCTURE OF THE VESSEL AND INSERTION OF THE WIRE. THIS CAN BE ADVANCED SO FAR THAT THE TIP OF THE WIRE IS CERTAINLY IN THE VESSEL, THEN SUDDENLY NO MORE ADVANCEMENT AND RETRACTION POSSIBLE, WIRE AS IF "BLOCKED". TURNING OR CHANGING THE POSITION OF THE NEEDLE DO NOTHING. FINALLY, WIRE AND NEEDLE ARE PULLED OUT OF VESSEL TOGETHER. NEW PUNCTURE OF PATIENT; DELAYED CATHETER INSERTION; POTENTIAL VESSEL DAMAGE BECAUSE BENT-OVER WIRE TIP COULD NOT BE PULLED BACK INTO NEEDLE."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17959306 ↗
• MalfunctionSep 12, 2023Material Frayed; Material Frayed

  IT WAS REPORTED "ONE KIT: THE HOSPITAL REVEALED THAT WHEN USING THE BARD CATHETER (MODEL: 5593200; BATCH: REFU1757), THE TIP OF THE NEEDLE TUBING WAS FOUND TWISTED. THE USE OF THE CONSUMABLE WAS UNABLE TO BE CONTINUED. THE REPORTED CONSUMABLE WAS STAINED WITH BLOOD AND THE SAMPLE CAN¿T BE MAILED BACK."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17730856 ↗
• MalfunctionSep 7, 2023Material Frayed; Material Frayed

  IT WAS REPORTED AFTER AN INCONSPICUOUS, SINGLE PUNCTURE UNDER ULTRASOUND CONTROL, THE GUIDE WIRE INCLUDED WITH THE NIAGARA SET CANNOT BE ADVANCED THROUGH THE NEEDLE AND REMAINS STUCK IN THE NEEDLE. WHEN TRYING TO PULL BACK THE GUIDE WIRE, IT CANNOT BE REMOVED FROM THE NEEDLE, BUT REMAINS SPRINGY AND GETS LONG. THE PUNCTURE IS REPEATED WITH ANOTHER PUNCTURE NEEDLE AND ANOTHER GUIDE WIRE AND THE NIAGARA IS PLACED WITHOUT COMPLICATIONS. NO WIRE DEBRIS CAN BE DETECTED ON THE POST-PUNCTURE CHEST X-RAY. NO PATIENT INJURIES OCCURRED DUE TO THE DESCRIBED INCIDENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17697989 ↗
• MalfunctionJun 1, 2023Material Frayed; Material Frayed

  IT WAS REPORTED THE PATIENT WAS ADMITTED TO HOSPITAL DUE TO DRUG POISONING. DURING TEMPORARY RENAL DIALYSIS CATHETER PLACEMENT IN FEMORAL VEIN ON (B)(6) 2023 DIALYSIS CATHETER WAS USED, BUT THE PUNCTURE NEEDLE COULD NOT BE PULLED OUT NORMALLY AFTER THE GUIDE WIRE WAS SENT INTO THE PUNCTURE NEEDLE, AND THE PUNCTURE NEEDLE AND GUIDE WIRE WERE IMMEDIATELY PULLED OUT OF THE PATIENT. AFTER THE GUIDE WIRE WAS PULLED OUT FORCIBLY, THE GUIDE WIRE WAS DEFORMED AND COULD NOT BE USED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17038949 ↗
• MalfunctionApr 6, 2023Material Frayed; Material Frayed

  BD VASCULAR ACCESS FIELD ASSURANCE RECEIVED A RETURNED GUIDEWIRE THAT WAS STUCK IN AN INTRODUCER NEEDLE AND THE WIRE WAS BROKEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16690994 ↗
• MalfunctionApr 4, 2023Material Frayed; Material Frayed

  IT WAS REPORTED, WIRE COULD BE INSERTED WITHOUT ANY PROBLEMS. A CORRECTION WAS DESIRED/NECESSARY IN THE CASE OF A VASCULAR OBSTRUCTION. WHEN THE WIRE WAS WITHDRAWN, THE TIP OF THE WIRE APPARENTLY JAMMED IN THE CANNULA (NOT AT THE TIP), MOBILIZATION IN ONE DIRECTION WAS NO LONGER POSSIBLE. AFTER PULLING THE CANNULA AND WIRE, THE PROBLEM PERSISTED EX-SITU, EVEN UNDER FORCED PRESSURE. NO IMPACT ON PATIENT, USER OR 3RD PERSON REPORTED, BUT DELAY IN CATHETER INSERTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16678320 ↗