Niagara Slim-Cath catheter 5553240Recalls & reported problems

Summary

The FDA's MAUDE database contains 22 adverse event reports that list this exact device (DI 00801741045370), received between Mar 18, 2016 and May 18, 2026 — classified as 2 injuries, 20 malfunctions.

The most frequently reported specific device problem is “Material Deformation” (6 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 22 most recent of 22 reports, 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 ↗
• 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 ↗
• 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 ↗
• 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 ↗
• MalfunctionFeb 25, 2025Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED BY THE CUSTOMER, DURING AN EMERGENCY PROCEDURE THE CATHETER INSERTION GUIDE BENT, MAKING IT DIFFICULT TO INSERT THE DEVICE. ADDITIONAL INFORMATION: IT WAS REPORTED THERE WAS NO SERIOUS DAMAGE, BUT IT WAS NECESSARY TO REPEAT THE MEDICAL PROCEDURE OF INSERTING A NEW DIALYSIS CATHETER. THERE WERE NO CHANGES TO THE TREATMENT, ONLY A SLOWDOWN IN THE PROCEDURE. 01/28/2025 - DURING EVALUATION OF THE RETURNED GUIDEWIRE, SOME CORE WIRE WEAKNESS WAS OBSERVED AT THE PROXIMAL END.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21462378 ↗
• MalfunctionAug 23, 2024Material Deformation; Material Deformation

  IT WAS REPORTED BY THE CUSTOMER "AT 16:30 ON JULY 8, 2024, THE POWER-ON TEST PASSED AND THE PIPELINE WAS INSTALLED. THE DIALYSIS CATHETER WAS INSERTED SMOOTHLY. THE BLOOD PUMPING BACK FROM THE ARTERIAL END WAS NOT SMOOTH, AND THE BLOOD PUMPED BACK FROM THE VENOUS END WAS SMOOTH. NORMAL OPERATION STARTED AT 17:00 TREATMENT, AT 17:30 THE CRRT MACHINE ALARM SHOWED THAT THE VENOUS PRESSURE WAS EXTREMELY POSITIVE, AND THE BLOOD PUMP STOPPED. IF THE CAUSE COULD NOT BE IDENTIFIED, I IMMEDIATELY CONTACTED THE ENGINEER FOR HELP, BUT TO NO AVAIL. AT THIS TIME, THERE WAS OBVIOUS STRATIFICATION OF BLOOD IN THE PIPELINE, AND THE BLOOD FILTER WAS COAGULATED AND COULD NOT RETURN BLOOD. FINALLY, HE WAS FORCED TO GET OFF THE MACHINE. WHEN WITHDRAWING THE CATHETER, IT WAS FOUND THAT THE INTERFACE END OF THE DIALYSIS CATHETER WAS ROTATED, TWISTED AND BENT (DURING THE TREATMENT, IT WAS NOT CHECKED BECAUSE IT WAS WRAPPED WITH GAUZE). AFTER THE TUBE WAS SEALED WITH CONCENTRATED HEPARIN, HE WAS READY TO GO ON THE MACHINE AGAIN. THE TREATMENT WAS SUCCESSFULLY COMPLETED AFTER THE SECOND TIME ON THE MACHINE." NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20048165 ↗
• MalfunctionJul 23, 2024Material Deformation; Material Deformation

  IT WAS REPORTED, ON (B)(6) 2024, THE PATIENT WAS GIVEN CRRT BLOOD PURIFICATION TREATMENT. AFTER THE TREATMENT STARTED, THE MACHINE SHOWED A HIGH-PRESSURE ALARM AND SUSPECTED THAT THE TUBING WAS NOT CLEAR, SO AFTER CHECKING THE TUBING, IT WAS FOUND TO BE A BENT AND TWISTED DIALYSIS CATHETER. THE PRESSURE OF THE PIPELINE RETURNED TO NORMAL AFTER IT WAS REFIXED. THE MACHINE OPERATED NORMALLY AND HAD NO ADVERSE EFFECTS ON THE PATIENT. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19807836 ↗
• MalfunctionApr 4, 2024Material Frayed; Material Frayed

  IT WAS REPORTED, ¿AT THE STAGE OF THE IMPLANTATION PROCEDURE, THE GUIDE IS DAMAGED WHILE SLIDING INTO THE NEEDLE. THE OPERATOR FELT RESISTANCE AND REMOVED THE GUIDE, RESULTING IN DAMAGE. THE OPERATOR OPENED A NEW KIT TO FINISH THE IMPLANTATION. THE PATIENT DID NOT EXPERIENCE ANY HARM.¿ NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19047393 ↗
• MalfunctionDec 12, 2023Crack; Fluid/Blood Leak; Crack; Fluid/Blood Leak

  IT WAS REPORTED BY THE CUSTOMER THE EVE OF NOVEMBER 22, THE DOCTOR PLACED AN INDWELLING HEMODIALYSIS CATHETER FOR THE PATIENT AND FOUND THAT THE PUNCTURE POINT WAS RUPTURED AND COULD NOT BE USED, RESULTING IN ANOTHER SET OF TUBES BEING DISMANTLED AND RE-INSTILLED. NO OTHER INFORMATION PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18314871 ↗
• MalfunctionOct 1, 2023Improper or Incorrect Procedure or Method; Defective Component; Improper or Incorrect Procedure or Method; Defective Component

  IT WAS REPORTED BY THE CUSTOMER "ON (B)(6) 2023, THE PATIENT UNDERWENT DIALYSIS CATHETER CATHETERIZATION AND CRRT TREATMENT WITH DIALYSIS CATHETER AS INSTRUCTED BY THE DOCTOR. THE CATHETERIZATION PROCESS WAS SMOOTH. AFTER CATHETERIZATION, THE CATHETER CLAMP WAS APPLIED TO CLAMP THE CATHETER. AFTER THE CLAMP WAS APPLIED, IT WAS FOUND THAT THERE WAS STILL BLOOD OUTFLOW AT THE CATHETER OPENING. AFTER CRRT TREATMENT, THE CATHETER CLAMP WAS ABLE TO COMPLETELY CLAMP THE CATHETER, AND THE SITUATION OF THE CATHETER WAS CLOSELY OBSERVED."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17849538 ↗
• MalfunctionDec 29, 2021Crack; Material Deformation; Crack; Material Deformation

  IT WAS REPORTED THAT WHEN THE CATHETER WAS PLACED IN THE RIGHT INTERNAL NECK, THE INTRODUCER NEEDLE WAS FOUND SPLIT FOLLOWING THE ENTRY INTO THE VESSEL. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13114092 ↗
• InjuryDec 4, 2020Complete Blockage

  IT WAS REPORTED THAT A NIAGARA HEMODIALYSIS CATHETER WAS INSERTED. IT WAS STATED THE VENOUS LINE WAS THROMBOSED 1 HOUR AFTER PLACEMENT, DESPITE ADHERENCE TO THE USUAL ANTICOAGULATION PROTOCOL.

  Patient problems: Thrombus

  MAUDE report 10944888 ↗
• MalfunctionDec 4, 2020Material Frayed

  IT WAS REPORTED THAT DURING CATHETER PLACEMENT, THE GUIDEWIRE ALLEGEDLY FRAYED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10944667 ↗
• MalfunctionNov 19, 2020Material Deformation; Material Deformation

  IT WAS REPORTED THAT DURING CATHETER INSERTION, THE GUIDE WIRE GOT STUCK IN INTRODUCER NEEDLE, UNABLE TO BE PULLED OUT. THE VASCULAR SHEATH WAS DEFECTIVE. THE SAME PROBLEM OCCURRED WITH TWO PRODUCTS. THE PROCEDURE WENT SMOOTHLY AFTER SWITCHING TO A THIRD ONE. ON 10/21/2020, PER EVALUATION FINDINGS, SAMPLES EXHIBITED DEFORMATION COMPRISING OUTWARD FLARING EDGES. THIS REPORT ADDRESSES THE SECOND DEVICE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10870063 ↗
• MalfunctionNov 19, 2020Material Deformation; Material Deformation

  IT WAS REPORTED THAT DURING CATHETER INSERTION, THE GUIDE WIRE GOT STUCK IN INTRODUCER NEEDLE, UNABLE TO BE PULLED OUT. THE VASCULAR SHEATH WAS DEFECTIVE. THE SAME PROBLEM OCCURRED WITH TWO PRODUCTS. THE PROCEDURE WENT SMOOTHLY AFTER SWITCHING TO A THIRD ONE. (B)(6) 2020, PER EVALUATION FINDINGS, SAMPLES EXHIBITED DEFORMATION COMPRISING OUTWARD FLARING EDGES. THIS REPORT ADDRESSES THE FIRST DEVICE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10870004 ↗
• MalfunctionNov 12, 2020Gas/Air Leak

  IT WAS REPORTED THAT THE INTRODUCER NEEDLE LEAKED AIR DURING OPERATIONS. THE PROCEDURE WAS DONE NORMALLY AFTER THE INTRODUCER NEEDLE WAS REPLACED. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10830691 ↗
• MalfunctionNov 12, 2020Gas/Air Leak

  IT WAS REPORTED THAT THE INTRODUCER NEEDLE LEAKED AIR DURING OPERATIONS. THE PROCEDURE WAS DONE NORMALLY AFTER THE INTRODUCER NEEDLE WAS REPLACED. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10830608 ↗
• MalfunctionApr 25, 2019Malposition of Device; Deformation Due to Compressive Stress

  IT WAS REPORTED THAT THE "GUIDEWIRE KINKS". IT WAS STATED, "GUIDEWIRE ISSUE APPEARS IN OPERATIONS DONE ON TIRED PATIENTS¿ WITH EXHAUSTED VASCULATURES. IF THE GUIDEWIRE KINKS OR NEEDLE MOVES TO A WRONG POSITION, PULLING THE GUIDEWIRE ALONE IS NOT POSSIBLE. AT THE SAME TIME, PULLING THE NEEDLE ALONG WITH THE GUIDEWIRE CAUSES LOSS OF ACCESS POINT AND DUE TO LIMITATION OF ACCESS POINTS, THIS IS NOT A PRACTICAL SOLUTION TO THE DOCTORS."

  Patient problems: No Information

  MAUDE report 8549252 ↗
• InjuryMar 12, 2019Material Integrity Problem

  IT WAS REPORTED THAT IN THE APPLICATION, IT WOULD ALWAYS BLEED A LOT FROM THE PUNCTURE SITE AND THEY COULD NOT STOP THE BLEEDING. HCP SAYS IT WOULD NOT BE AN USER ERROR BUT THE DILATATION CATHETER WOULD BE TOO BIG. THEREFORE CATHETER WAS REMOVED AND A NEW CATHETER WAS USED (COMPETITOR PRODUCT).

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 8414214 ↗
• MalfunctionDec 11, 2018Physical Resistance/Sticking

  IT WAS REPORTED THAT THE GUIDE WIRE WAS STUCK AT THE POSITION OF THE NEEDLE AND COULD NOT BE PULLED OUT. ON (B)(6) 2018, RETURNED WIRE IS BROKEN.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8152736 ↗
• MalfunctionSep 13, 2018Leak/Splash

  IT WAS REPORTED THAT THERE WAS AIR LEAKAGE, NO BLOOD PUMPED OUT WHEN BLOOD VESSEL WAS BEING PUNCTURED, AFFECTING JUDGMENT, UNABLE TO OPERATE. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7873841 ↗
• MalfunctionMar 18, 2016Sticking; Device Operates Differently Than Expected

  IT WAS REPORTED THAT DURING WITHDRAWAL OF THE GUIDEWIRE, IT WAS STUCK TO THE PUNCTURE NEEDLE. THE PHYSICIAN THEN NOTICED THAT THE GUIDEWIRE STARTED TO RAVEL, CAUSING THE MANDRIN AND THE PUNCTURE NEEDLE TO BE REMOVED AT SAME TIME. THEY TOOK ANOTHER CATHETER AND RESTARTED THE PROCEDURE COMPLETELY. PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 5512206 ↗