Niagara catheterRecalls & reported problems across all models

We found 6 models of Niagara catheter by Bard Access Systems, Inc. in the FDA's device registry (GUDID). Together they are named in 146 adverse event reports in the FDA's MAUDE database, received between Nov 6, 2015 and May 21, 2026 — classified as 9 injuries, 137 malfunctions.

The most frequently reported specific device problem is “Material Deformation” (37 reports).

1 FDA recall record name at least one of these models by its device identifier, 1 still open.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Niagara catheter recalls

FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.

1. Aug 10, 2026Class IOpen, Classified

   this is a downstream recall of class I recall RES 98777

   Z-2985-2026 · Root cause: Material/Component Contamination · Recall details · FDA record ↗

Most reported Niagara catheter problems

Niagara catheter models

6 models, most reported first. Each model has its own page with its reports, recalls and device details.

• Niagara catheter 5593200

  CATHETER, HEMODIALYSIS, NON-IMPLANTED
  53 reports
• Niagara catheter 5766200

  CATHETER, HEMODIALYSIS, NON-IMPLANTED
  1 recall0 reports
• Niagara catheter 5593240

  CATHETER, HEMODIALYSIS, NON-IMPLANTED
  40 reports
• Niagara catheter 5594150

  CATHETER, HEMODIALYSIS, NON-IMPLANTED
  35 reports
• Niagara catheter 5593150

  CATHETER, HEMODIALYSIS, NON-IMPLANTED
  17 reports
• Niagara catheter 5575150

  CATHETER, HEMODIALYSIS, NON-IMPLANTED
  1 report

Recent Niagara catheter adverse event reports

The 15 most recent reports across all models, 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 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 ↗
• 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 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 ↗
• 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 ↗
• 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 ↗
• 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 ↗
• 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 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 ↗

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