Niagara Slim-Cath catheter 5553150Recalls & reported problems

Summary

The FDA's MAUDE database contains 22 adverse event reports that list this exact device (DI 00801741045356), received between Mar 12, 2019 and Mar 30, 2026 — classified as 3 injuries, 19 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.

• 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 ↗
• 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 ↗
• 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 ↗
• MalfunctionJan 15, 2025Material Deformation; Material Deformation

  IT WAS REPORTED WHEN THE CATHETER WAS UNPACKED, IT WAS FOUND THAT THE CATHETER WAS VISIBLY CREASED AND COULD NOT BE DELIVERED INTO THE BODY DURING PUNCTURE, WHICH DID NOT ENSURE PROPER FUNCTIONING OF THE CATHETER. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21162219 ↗
• MalfunctionNov 22, 2024Material Deformation; Material Deformation

  IT WAS REPORTED THE GUIDEWIRE EASILY KINKS. IT WAS REPORTED THIS OCCURRED WITH FOUR DEVICES. THIS REPORT WILL ADDRESS ALL FOUR DEVICES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20764148 ↗
• MalfunctionSep 27, 2024Material Deformation; Material Deformation

  IT WAS REPORTED THE GUIDEWIRE KINKED DURING THREADING, NECESSITATING OPENING OF ANOTHER KIT TO COMPLETE THE PROCEDURE. THIS MADE THE PROCEDURE LENGTHY BUT DID NOT INJURE THE PATIENT. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20322840 ↗
• MalfunctionNov 7, 2023Component Incompatible; Component Incompatible

  IT WAS REPORTED THAT GUIDEWIRE AND PINK NEEDLE CANNOT BE REMOVED. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18089474 ↗
• MalfunctionNov 2, 2023Component Incompatible; Component Incompatible

  IT WAS REPORTED THAT GUIDEWIRE AND PINK NEEDLE CANNOT BE REMOVED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18062052 ↗
• InjuryAug 28, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED ON (B)(6) 2023, DUE TO CHRONIC KIDNEY DISEASE STAGE 5 PATIENT WAS ADMITTED TO THE RENAL DEPARTMENT, TEMPORARY CATHETERIZATION OF RIGHT INTERNAL JUGULAR VEIN WAS PERFORMED ON THE SAME DAY. ON (B)(6) 2023, LEFT FOREARM ARTERIOVENOUS FISTULA. ON (B)(6) 2023, THE HEMODIALYSIS PROCESS WAS SMOOTH, THE GENERAL CONDITION WAS OK, PATIENT WAS DISCHARGED FROM THE DEPARTMENT, TRANSFERRED FOR REGULAR HEMODIALYSIS (THROUGH THE RIGHT INTERNAL JUGULAR VEIN TEMPORARY TUBE). AT THE END OF JUNE, FEVER APPEARED SHORTLY AFTER HEMODIALYSIS, AND SHE WAS HOSPITALIZED AND REPORTED ANTI-INFECTION TREATMENT. THE SPECIFIC COURSE OF TREATMENT IS UNKNOWN. ON (B)(6) 2023, DUE TO POOR ANTI-INFECTION TREATMENT, SHE WAS HOSPITALIZED IN EICU. ON THE DAY OF ADMISSION, THE RIGHT INTERNAL JUGULAR VEIN CATHETER WAS REMOVED AND THE RIGHT FEMORAL VEIN TEMPORARY CATHETER (ARROW) WAS PLACED. ON (B)(6) 2032, TRANSFERRED TO RENAL DEPARTMENT FOR FURTHER TREATMENT.

  Patient problems: Alteration in Body Temperature

  MAUDE report 17638704 ↗
• InjuryAug 28, 2023Break; Break

  IT WAS REPORTED THAT ON "06.08, DUE TO CHRONIC KIDNEY DISEASE STAGE 5 ADMITTED TO THE RENAL DEPARTMENT, TEMPORARY CATHETERIZATION OF RIGHT INTERNAL JUGULAR VEIN WAS PERFORMED ON THE SAME DAY. ON 06.14, LEFT FOREARM ARTERIOVENOUS FISTULA. 06.19, THE HEMODIALYSIS PROCESS WAS SMOOTH, THE GENERAL CONDITION WAS OK, PATIENT WAS DISCHARGED FROM THE DEPARTMENT, TRANSFERRED TO FACILITY REGULAR HEMODIALYSIS (THROUGH THE RIGHT INTERNAL JUGULAR VEIN TEMPORARY TUBE). 07.03, PATIENT WAS HOSPITALIZED IN EICU OF OUR HOSPITAL. ON THE DAY OF ADMISSION, THE RIGHT INTERNAL JUGULAR VEIN CATHETER WAS REMOVED AND THE RIGHT FEMORAL VEIN TEMPORARY CATHETER WAS PLACED. 07.10, TRANSFERRED TO RENAL DEPARTMENT FOR FURTHER TREATMENT. 07.13, PULMONARY ARTERY CT EXAMINATION SHOWED NO FOREIGN BODY. 07.14, RIGHT FEMORAL VEIN CATHETERIZATION WAS REMOVED AND RIGHT INTERNAL JUGULAR VEIN TEMPORARY CATHETERIZATION WAS PERFORMED IN RENAL DEPARTMENT. 07.21, PULMONARY CT EXAMINATION SHOWED A DENSE SHADOW IN THE RIGHT LOWER PULMONARY ARTERY. 07.26: PULMONARY ANGIOGRAPHY AND FOREIGN BODY REMOVAL UNDER DSA WERE TO BE PERFORMED. DUE TO NON-DEVELOPMENT, THE FOREIGN BODY COULD NOT BE REMOVED. THE SPECIFIC FOREIGN BODY CONDITION

  Patient problems: Foreign Body In Patient

  MAUDE report 17638570 ↗
• MalfunctionMar 12, 2023Material Frayed; Material Frayed

  IT WAS REPORTED THAT THE GUIDE WIRE GOT STUCK, UNABLE TO PASS. NO OTHER INFORMATION WAS PROVIDED. 02/21/2023- THE RETURNED GUIDEWIRE WAS CONFIRMED TO BE BROKEN AND THE OUTER COIL WIRE BECAME UNRAVELED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16527271 ↗
• MalfunctionDec 7, 2022Contamination /Decontamination Problem; Contamination /Decontamination Problem

  IT WAS REPORTED THAT THERE WERE BLACK FOREIGN MATTERS WITH THE GUIDE WIRE. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15932624 ↗
• MalfunctionJun 10, 2022Material Frayed; Material Deformation; Material Frayed; Material Deformation

  IT WAS REPORTED THE WIRE WAS KINKING IN THE CATHETER. PATIENT STATUS/ INTERVENTION: CHANGE NEW KIT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14653705 ↗
• MalfunctionNov 11, 2021Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED A CATHETER WAS PLACED FOR THE TREATMENT OF CHRONIC KIDNEY DISEASE AND DIALYSIS TREATMENT WAS PERFORMED. WHEN THE PATIENT WAS TREATED WITH CRRT ON (B)(6) 2021, HE FOUND THAT THE ARTERIAL END OF THE DIALYSIS CATHETER WAS SUSPECTED TO BE RUPTURED AND A SMALL AMOUNT OF BLOOD LEAKED OUT. THE CRRT TREATMENT WAS IMMEDIATELY STOPPED, THE DIALYSIS CATHETER WAS PULLED OUT, AND THE CATHETER WAS REPLACED. CONTINUED TREATMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12796926 ↗
• MalfunctionSep 10, 2021Component Incompatible; Component Incompatible

  IT WAS REPORTED THAT THE GUIDE WIRE GOT STUCK, UNABLE TO BE INSERTED NOR WITHDRAWN. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12453573 ↗
• MalfunctionAug 4, 2021Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THE CONNECTION BETWEEN THE INFUSION TUBING AND SCALP NEEDLE LEAKED WATER WHEN CONDUCTING INFUSION FOR BED 10 PATIENT IN THE AFTERNOON. AN INSPECTION SHOWED A SMALL DAMAGE WITH THE CONNECTOR. THE PROBLEM WAS RESOLVED AFTER THE INFUSION SETS WERE REPLACED. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12278534 ↗
• MalfunctionJul 8, 2021Break; Break

  IT WAS REPORTED THAT THE CATHETER WAS RUPTURED WHEN PERFORMING PUNCTURE FOR SHORT-TERM DIALYSIS. NO OTHER INFORMATION PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12135580 ↗
• MalfunctionApr 25, 2019Malposition of Device; Material Deformation

  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 Known Impact Or Consequence To Patient

  MAUDE report 8549250 ↗
• MalfunctionApr 25, 2019Deformation 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 8549249 ↗
• MalfunctionApr 25, 2019Malposition of Device; Material Deformation

  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 Known Impact Or Consequence To Patient

  MAUDE report 8549097 ↗
• InjuryMar 12, 2019Display or Visual Feedback 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 STATED 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 8414010 ↗