Niagara Slim-Cath catheterRecalls & reported problems across all models
Bard Access Systems, Inc. · 4 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 120
- Deaths reported
- 0
- Injuries reported
- 6
- Recalls
- 0
We found 4 models of Niagara Slim-Cath catheter by Bard Access Systems, Inc. in the FDA's device registry (GUDID). Together they are named in 120 adverse event reports in the FDA's MAUDE database, received between Dec 28, 2015 and May 18, 2026 — classified as 6 injuries, 114 malfunctions.
The most frequently reported specific device problem is “Material Deformation” (30 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. 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
Reports received per month, all models
Most reported Niagara Slim-Cath catheter problems
Device problems
- Material Deformation30
- Material Frayed26
- Fluid/Blood Leak18
- Component Incompatible9
- Crack8
- Defective Component8
- Break7
- Gas/Air Leak5
Patient problems
- No Clinical Signs, Symptoms or Conditions71
- No Consequences Or Impact To Patient20
- No Known Impact Or Consequence To Patient17
- No Information5
- Hemorrhage/Blood Loss/Bleeding4
- Alteration in Body Temperature1
- Distress1
- Foreign Body In Patient1
Niagara Slim-Cath catheter models
4 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Niagara Slim-Cath catheter 5553200CATHETER, HEMODIALYSIS, NON-IMPLANTED75 reports
- Niagara Slim-Cath catheter 5553150CATHETER, HEMODIALYSIS, NON-IMPLANTED22 reports
- Niagara Slim-Cath catheter 5553240CATHETER, HEMODIALYSIS, NON-IMPLANTED22 reports
- Niagara Slim-Cath catheter 5551240CATHETER, HEMODIALYSIS, NON-IMPLANTED1 report
Recent Niagara Slim-Cath catheter adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionMay 18, 2026Fluid/Blood Leak
IT WAS REPORTED THAT AT 11:30 A.M. ON (B)(6) 2026, THE PATIENT REQUIRED DIALYSIS TREATMENT DUE TO HYPERKALEMIA AND ACUTE KIDNEY INJURY. THE NURSE PERFORMED PRE-TREATMENT PREPARATIONS IN ACCORDANCE WITH STANDARD HEMODIALYSIS OPERATING PROCEDURES. AFTER DISINFECTING THE DIALYSIS CATHETER CONNECTOR USING ASEPTIC TECHNIQUE, THE NURSE PERFORMED A ROUTINE BACKFLUSH WITH A SYRINGE, BUT NO BLOOD RETURNED THROUGH THE CATHETER; THE PATIENT¿S POSITION WAS CHECKED, AND THE EXTERNAL SEGMENT OF THE CATHETER WAS FOUND TO BE FREE OF KINKS AND SECURELY IN PLACE. AFTER RULING OUT FACTORS RELATED TO TECHNIQUE AND PATIENT POSITIONING, FURTHER EXAMINATION REVEALED THAT THE DIALYSIS CATHETER WAS DAMAGED, PREVENTING NORMAL BLOOD DRAW AND INITIATION OF DIALYSIS. A NEW DIALYSIS CATHETER WAS THEREFORE REPLACED, BLOOD WAS DRAWN, AND THE MACHINE WAS STARTED; SUBSEQUENT TREATMENT PROCEEDED NORMALLY. NO FURTHER DETAILS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25205260 ↗MalfunctionMay 5, 2026Fluid/Blood Leak
IT WAS REPORTED DURING THE IMPLANTATION OF A SHORT-TERM CATHETER, A FLUID LEAK OCCURRED. CATHETER WAS NOT TESTED PRIOR TO USE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25088050 ↗MalfunctionMar 30, 2026Component Incompatible
IT WAS REPORTED THAT GUIDEWIRE STUCK WITH NEEDLE. NO PATIENT INJURY WAS REPORTED. NO FURTHER DETAILS WERE PROVIDED. 03/12/2026: THE RETURNED DEVICE EXHIBITED A BENT GUIDEWIRE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24734793 ↗MalfunctionFeb 25, 2026Material Frayed
IT WAS REPORTED THAT DURING THE PLACEMENT OF CATHETER ENCOUNTERED AN ISSUE WHERE THE GUIDEWIRE BECAME STUCK AFTER PARTIAL INSERTION INTO THE INTRODUCER NEEDLE. DESPITE MULTIPLE ATTEMPTS, THE GUIDEWIRE COULD NOT BE ADVANCED FURTHER. ULTIMATELY, A BACKUP PRODUCT OF THE SAME MODEL WAS USED TO COMPLETE THE CATHETERIZATION. NO FURTHER DETAILS WERE PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24447256 ↗MalfunctionFeb 24, 2026Material Deformation
IT WAS REPORTED THAT THE PUNCTURE SHEATH FAILED TO SUCCESSFULLY PENETRATE THE VESSEL DURING THE PROCEDURE. UPON REMOVAL, THE SHEATH TIP WAS FOUND SEVERELY DAMAGED, RENDERING IT UNUSABLE FOR ANOTHER ATTEMPT. A NEW CATHETER HAD TO BE INSERTED FOR THE CATHETERIZATION PUNCTURE. NO FURTHER DETAILS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24429709 ↗MalfunctionJan 6, 2026Component Incompatible
IT WAS REPORTED THE GUIDE WIRE IS IRREVERSIBLY STUCK IN THE PUNCTURE NEEDLE. NO PATIENT INJURY WAS REPORTED. (B)(6) 2025- IT WAS FOUND DURING AN INVESTIGATION THE PROXIMAL END OF THE GUIDEWIRE WAS OBSERVED TO ELONGATE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23983305 ↗MalfunctionDec 16, 2025Material Deformation; Material Deformation
IT WAS REPORTED GUIDE-WIRE BRANCH DURING SURGERY. NO OTHER DEVICES WERE USED DURING NORMAL OPERATION. NO PATIENT INJURY WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23820963 ↗MalfunctionNov 18, 2025Material Deformation; Material Deformation
IT WAS REPORTED DURING THE USE OF THE SHORT TRANSLUMINAL CATHETER, THE OPENING OF THE PUNCTURE SHEATH CRACKED, PREVENTING NORMAL CATHETER ADVANCEMENT. AS A RESULT, CATHETER PLACEMENT COULD NOT BE COMPLETED. A NEW CATHETER SET WAS INITIATED TO SUCCESSFULLY ESTABLISH CATHETER PLACEMENT IN THE PATIENT. NO INJURY TO PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23585507 ↗MalfunctionNov 4, 2025Component Incompatible; Material Frayed; Component Incompatible; Material Frayed
IT WAS REPORTED DURING A HEMODIALYSIS PROCEDURE AT THE HOSPITAL, A PHYSICIAN ATTEMPTED TO INSERT A SHORT-TERM CATHETER INTO A PATIENT. AFTER SUCCESSFUL PUNCTURE, THE GUIDEWIRE COULD NOT PASS THROUGH THE INTRODUCER NEEDLE. DESPITE MULTIPLE ADJUSTMENTS, THE WIRE REMAINED STUCK. ULTIMATELY, A BACKUP PRODUCT OF THE SAME MODEL WAS USED TO COMPLETE THE CATHETERIZATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23467202 ↗MalfunctionJul 30, 2025Material Frayed; Material Frayed
IT WAS REPORTED THAT PULLING OF THE GUIDEWIRE WITH LOTS OF STRETCHING; THE CLINICIAN SEEMS TO UNRAVEL THE COIL AT THE END.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22664501 ↗MalfunctionJul 11, 2025Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED ON (B)(6) 2025 PULMONARY EDEMA PATIENT WITH AN AIR LEAK MANIFESTED WHILE USING AN INDWELLING FEMORAL VEIN DIALYSIS CATHETER. A LEFT FEMORAL VEIN WAS PLACED AND WAS FOUND TO BE LEAKING SIGNIFICANTLY RESULTING IN THE NEED FOR AN ADDITIONAL SEPARATE PUNCTURE KIT TO BE REMOVED. THIS RESULTED IN REPEATED PUNCTURES AND SIGNIFICANTLY LONGER PUNCTURE TIME, WHICH WAS NOT TOLERATED BY THE PATIENT.
Patient problems: Distress
MAUDE report 22481072 ↗MalfunctionJun 24, 2025Defective Component; Defective Component
IT WAS REPORTED THE GUIDEWIRE WAS DIFFICULT TO PULL OUT DURING INSERTION PUNCTURE WITH THIS DIALYSIS CATHETER ON MAY 28, AND FORCING IT OUT REVEALED THAT THE GUIDEWIRE IS DEFORMED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22319983 ↗MalfunctionMay 6, 2025Material Frayed; Defective Component; Material Frayed; Defective Component
IT WAS REPORTED BY THE CUSTOMER THAT WHILE USING MATERIAL 5553150, THE GUIDEWIRE CANNOT BE PULLED OUT. NO FURTHER INFORMATION PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21969887 ↗MalfunctionApr 30, 2025Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED (B)(6) 2025, AT 22:30: WHEN PERFORMING A RIGHT FEMORAL VEIN HEMODIALYSIS PUNCTURE ON A PATIENT, AFTER OPENING THE PACKAGE, THE DOCTOR FOUND THAT THE HEMODIALYSIS TUBING (MODEL 20 CM) WAS LEAKING FROM THE SIDE OF THE CANNULA WHEN FLUSHING THE TUBING WITH 0.9% SODIUM CHLORIDE INJECTION, RENDERING THE ENTIRE SET OF HEMODIALYSIS UNUSABLE. A NEW SET OF TUBING AND CANNULA WAS IMMEDIATELY REPLACED. THIS INCIDENT DID NOT RESULT IN PERSONAL INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21940321 ↗MalfunctionMar 25, 2025Material Deformation; Material Deformation
IT WAS REPORTED THAT THE GUIDEWIRE COULD NOT BE RETRACTED SUCCESSFULLY. THE TIP SEEMS KINK. NO OTHER INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21694377 ↗
Other Bard Access Systems, Inc. products
- Port Access Needle122 models · 3,744 reports · 3 recalls
- Groshong NXT ClearVue Catheter8 models · 3,266 reports
- PowerPort ClearVUE27 models · 1,993 reports · 15 recalls
- Site~Rite 8 Ultrasound System11 models · 1,965 reports
- PowerPort M.R.I., ChronoFlex22 models · 1,642 reports · 1 recall
- PowerPICC Provena116 models · 1,337 reports · 2 recalls
- PowerPort M.R.I., Groshong10 models · 1,285 reports
- Navarre15 models · 1,228 reports
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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