Niagara Slim-Cath catheter 5553200Recalls & reported problems

Summary

The FDA's MAUDE database contains 75 adverse event reports that list this exact device (DI 00801741045363), received between Dec 28, 2015 and May 5, 2026 — classified as 1 injury, 74 malfunctions.

The most frequently reported specific device problem is “Material Deformation” (18 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 75 reports, in the reporter's own words as published by the FDA.

• 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 ↗
• 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 ↗
• 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 ↗
• 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 ↗
• MalfunctionOct 2, 2024Material Deformation; Material Deformation

  IT WAS REPORTED THAT PATIENT (B)(6) 2024 DUE TO THE CONDITION OF THE DIALYSIS CATHETER NEEDS TO BE PLACED IN THE BEDSIDE CRRT TREATMENT, THE DOCTOR IN ACCORDANCE WITH THE OPERATION SPECIFICATION PUNCTURE, AFTER PLACING THE GUIDEWIRE, ALONG THE GUIDEWIRE INTO THE DIALYSIS CATHETER, THE RESISTANCE IS LARGE, AFTER THE WITHDRAWAL OF THE GUIDEWIRE TO CHECK THE GUIDEWIRE HAS BEEN FOLDED, THE USE OF THE DEEP VEIN PUNCTURE KIT PUNCTURE NEEDLE AND GUIDEWIRE TO CONTINUE TO GIVE THE PUNCTURE, THE PUNCTURE AND PLACEMENT OF THE TUBE WAS SUCCESSFUL. NO OTHER INFORMATION PROVIDED, AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20355056 ↗
• MalfunctionSep 27, 2024Material Deformation; Material Deformation

  IT WAS REPORTED THAT ON 2024.9.1 THE PHYSICIAN LEAVES A DIALYSIS CATHETER IN PLACE FOR THE PATIENT TO PREPARE FOR CRRT TREATMENT, AND THE GUIDEWIRE FAILS TO FEED DURING THE PUNCTURE PROCESS. UPON INSPECTION, THE GUIDEWIRE IS FOUND TO BE BENT, AND THE PHYSICIAN REPLACES IT WITH A NEW DIALYSIS CATHETER FOR THE PUNCTURE, AND THE GUIDEWIRE FEEDS NORMALLY, AND THE PUNCTURE IS COMPLETED SUCCESSFULLY. NO OTHER INFORMATION PROVIDED, AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20321519 ↗
• InjurySep 5, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED ON (B)(6) 2024, THE PATIENT WAS ADMITTED TO THE HOSPITAL (DRUG INTOXICATION), AND ON THE SAME DAY, A DIALYSIS CATHETER WAS PLACED FOR HEMOPERFUSION TREATMENT (ENOXAPARIN TO MAINTAIN ANTICOAGULATION), AND ON THE THIRD DAY (6.8), THE PATIENT WAS TRANSFERRED TO THE CITY'S HOSPITAL AND FOUND TO HAVE A THROMBUS (THE EXACT LOCATION OF WHICH WAS IN THE RIGHT FEMORAL VEIN), AND WAS THEN TRANSFERRED TO ANOTHER HOSPITAL, WHERE AN INFERIOR VENA CAVA FILTER WAS PUT IN PLACE TO PREVENT THE THROMBUS FROM DISLODGING AND ENTERING INTO THE BLOOD CIRCULATION. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 20153851 ↗
• MalfunctionJul 23, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT A LARGE NUMBER OF BUBBLES APPEARED WHEN USING THE DIALYSIS CATHETER. CONFIRM THAT THE POSITION IS CORRECT. WHEN UNPLUGGING, A LARGE NUMBER OF BUBBLES APPEARED WHEN PUMPING WATER. THERE WAS A PROBLEM WITH THE REVERSE FLOW OF THE CATHETER. THERE WAS A PROBLEM WITH THE CATHETER. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19805904 ↗
• MalfunctionJul 2, 2024Crack; Suction Problem; Crack; Suction Problem

  IT WAS REPORTED THAT AFTER THE CATHETER WAS PUNCTURED, IT WAS FOUND THAT BLOOD COULD NOT BE WITHDRAWN. AFTER THE CATHETER WAS REPLACED, IT WORKED NORMALLY. THE CUSTOMER REPORTED THAT THE CATHETER WAS NOT SMOOTH. THERE WAS NO IMPACT TO THE PATIENT. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19657561 ↗
• MalfunctionJul 1, 2024Material Frayed; Difficult to Remove; Material Frayed; Difficult to Remove

  IT WAS REPORTED THAT THE PIPE IS STUCK AND CANNOT BE PULLED OUT. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19644961 ↗
• MalfunctionJun 18, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED CATHETER LEAKAGE IS DETECTED DURING PRE-FLUSHING CATHETER PREPARATION PRIOR TO PUNCTURE. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19558236 ↗
• MalfunctionMay 1, 2024Material Frayed; Material Frayed

  IT WAS REPORTED BY THE CUSTOMER "CANNOT ADVANCE CATHETER OVER GUIDEWIRE, CANNOT RETRACT GUIDEWIRE THROUGH CATHETER. RAISING GUIDEWIRE WAS NOT POSSIBLE (SIDE J TIP), AFTERWARDS OTHER SIDE OF (STRAIGHT SIDE) GUIDEWIRE COULD RAISE, DILATE OK, CATHETER ONLY ABLE TO SLIDE 12 CM OVER GUIDEWIRE. WANTED TO REMOVE GUIDEWIRE BUT COULD NOT. GUIDEWIRE STUCK IN THE CATHETER. PATIENT WAS IN AN UNCOMFORTABLE POSITION FOR MUCH LONGER AND HAD TO BE PRICKED SEVERAL TIMES." NO OTHER INFORMATION WAS PROVIDED. 4/18/2024 - THE GUIDEWIRE RETURNED FOR EVALUATION REVEALED THE CORE WIRE WAS BROKEN AT THE J-TIP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19226481 ↗
• MalfunctionMar 23, 2024Material Frayed; Material Frayed

  IT WAS REPORTED GUIDEWIRE STUCK. THE EVENT DID NOT RESULT IN SERIOUS INJURY. TREATMENT PLAN DID NOT HAVE TO BE CHANGED AS A RESULT OF THIS INCIDENT. THE PLACEMENT HAD TO BE DONE AGAIN WHICH RESULTED IN THE PATIENT BEING IN AN UNCOMFORTABLE POSITION FOR MUCH LONGER AND HAVING TO BE PUNCTURED SEVERAL TIMES. THE NIAGARA CATHETER WAS EVENTUALLY NOT USED AND SWITCHED TO ANOTHER BRAND STILL PRESENT FROM BEFORE THE CATHETER CHANGE. 02/26/2024 - THE GUIDEWIRE RETURNED FOR EVALUATION WAS BROKEN AND UNRAVELED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18965553 ↗
• MalfunctionMar 8, 2024Material Deformation; Material Deformation

  IT WAS REPORTED THAT THERE ARE UNKNOWN PLASTIC GLANDS AND RUPTURES ON THE DILATOR. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18865112 ↗
• MalfunctionMar 7, 2024Defective Component; Material Deformation; Defective Component; Material Deformation

  IT WAS REPORTED THAT THERE ARE UNKNOWN PLASTIC GLANDS AND RUPTURES ON THE DILATOR. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18862814 ↗
• MalfunctionFeb 7, 2024Material Frayed; Defective Component; Material Frayed; Defective Component

  IT WAS REPORTED GUIDEWIRE COULD NOT BE PULLED OUT. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18664591 ↗
• MalfunctionJan 19, 2024Material Frayed; Material Deformation; Material Frayed; Material Deformation

  IT WAS REPORTED THAT THE WIRE IS STUCK AND CANNOT BE PULLED OUT. 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 18544634 ↗
• MalfunctionJan 19, 2024Material Deformation; Material Deformation

  IT WAS REPORTED THAT THE WIRE IS STUCK AND CANNOT BE PULLED OUT. 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 18544588 ↗
• MalfunctionJan 2, 2024Crack; Crack

  IT WAS REPORTED THE PUNCTURE NEEDLE IS RUPTURED AT THE END OF THE NEEDLE, AND THE PUNCTURE AND CATHETERIZATION CANNOT BE SUCCESSFULLY COMPLETED. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18430358 ↗
• MalfunctionDec 29, 2023Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  IT WAS REPORTED BY CUSTOMER VIA MEDWATCH, "VASCULAR CATHETER INSERTED ON (B)(6) 2023. DURING INSERTION IT WAS DETERMINED THAT THE STYLET USED AS INTENDED TO HELP STABILIZE THE LUMEN DURING THE INSERTION PROCESS WAS NOT IMMEDIATELY REMOVED. THE STYLET WAS EASILY REMOVED BY UNSCREWING THE CAP AT THE END OF THE LUMEN AND THEN WITHDRAWN. EDUCATION WAS GIVEN POST REVIEW TO PULMONARY FELLOWS ON THE CATHETER AND THE NEED TO REMOVE THE STYLET AT THE END OF THE INSERTION PROCEDURE. DUE TO AVAILABILITY, OLDER PRODUCT SUPPLIED BY BARD FOR SHORT TERM DIALYSIS CATH, FELLOWS UNFAMILIAR WITH REMOVAL ON THIS PARTICULAR CATHETER. NO RETAINED OBJECT OR ADVERSE EFFECTS."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18418814 ↗
• MalfunctionDec 6, 2023Component Incompatible; Material Frayed; Component Incompatible; Material Frayed

  CUSTOMER REPORTED AFTER THE GUIDEWIRE ENTERS THE PUNCTURE NEEDLE, IT CANNOT ENTER THE BLOOD VESSEL, AND THE NEEDLE AND GUIDEWIRE ARE WITHDRAWN, AND THE GUIDEWIRE CANNOT BE REMOVED FROM THE PUNCTURE NEEDLE. NO OTHER INFORMATION PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18279801 ↗
• MalfunctionSep 18, 2023Material Frayed; Defective Component; Material Frayed; Defective Component

  IT WAS REPORTED THAT THE PATIENT HAD THE PRODUCT INSTALLED DUE TO THE NEED FOR DIALYSIS. WHEN PLACING PER THE STANDARD OPERATING PROCEDURE, THE DOCTOR FOUND THAT THE GUIDE WIRE WAS DEFORMED. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17769316 ↗