Niagara catheter 5593150Recalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 00801741045561), received between Nov 6, 2015 and Jun 18, 2024 — classified as 17 malfunctions.

The most frequently reported specific device problem is “Crack” (3 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 17 most recent of 17 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 18, 2024Crack; Crack

  IT WAS REPORTED THE INCIDENT OCCURRED IN THE DEPARTMENT OF NEPHROLOGY, AND THE CATHETERIZATION DOCTOR SAID THAT THE PUNCTURE NEEDLE IN THE SHORT DIALYSIS CATHETER KIT WAS FOUND TO BE DAMAGED DURING THE CATHETER PLACEMENT PROCESS, AND THERE WAS BLOOD LEAKAGE AND AIR LEAKAGE DURING THE SUCTION PROCESS. AFTER REPLACING THE CATHETER SET WITH A NEW ONE, TRANSPLANTATION WAS SUCCESSFULLY COMPLETED. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 19558244 ↗
• MalfunctionApr 16, 2024Material Frayed; Material Frayed

  IT WAS REPORTED, "NEEDLE LEAKAGE WAS FOUND BEFORE USE, THE GUIDEWIRE IS DEFORMED." NO OTHER INFORMATION WAS PROVIDED. 03/26/2024: THE RETURNED DEVICE EXHIBITED A BROKEN GUIDEWIRE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19114940 ↗
• MalfunctionFeb 5, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED BY THE CUSTOMER "ON (B)(6)2024, THE CATHETER WAS FOUND TO BE LEAKING DURING THE CATHETERIZATION OF THE PATIENT, AND THE CATHETER WAS SUBSEQUENTLY REPLACED WITH A NEW CATHETER FOR PLACEMENT." NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18643761 ↗
• MalfunctionAug 9, 2023Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT DURING CATHETER PLACEMENT BY THE OPERATOR ON (B)(6) 2023, THE CATHETER WAS PRE-FLUSHED TO INSPECT THE CATHETER FOR INTEGRITY. IT WAS FOUND THAT THE CATHETER LEAKED LIQUID AND WAS IMMEDIATELY REPLACED WITH A NEW CATHETER FOR OPERATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17494667 ↗
• MalfunctionJun 9, 2023Crack; Crack

  IT WAS REPORTED THE CANNULA BROKE OFF WITHOUT MUCH FORCE. 02 JUNE 2023 ADDITIONAL INFORMATION FROM THE CUSTOMER: EVENT HAPPENED ON (B)(6) 2023 DURING USE. PATIENT HAD TO BE PUNCTURED SEVERAL TIMES AND CAUSED A DELAY IN THERAPY. 1 NEEDLE BROKEN DURING PUNCTURE, 1 NEEDLE BROKEN DURING PREPARATION. THIS FILE ADDRESSES THE ISSUE WITH THE NEEDLE BROKEN DURING PREPARATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17097652 ↗
• MalfunctionJun 9, 2023Crack; Crack

  IT WAS REPORTED THE CANNULA BROKE OFF WITHOUT MUCH FORCE. 02 JUNE 2023 ADDITIONAL INFORMATION FROM THE CUSTOMER: EVENT HAPPENED ON (B)(6) 2023 DURING USE. PATIENT HAD TO BE PUNCTURED SEVERAL TIMES AND CAUSED A DELAY IN THERAPY. 1 NEEDLE BROKEN DURING PUNCTURE, 1 NEEDLE BROKEN DURING PREPARATION. THIS FILE ADDRESSES THE ISSUE WITH THE NEEDLE BROKEN DURING PUNCTURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17097650 ↗
• MalfunctionMay 20, 2022Component Incompatible; Component Incompatible

  IT WAS REPORTED FROM THE CUSTOMER THAT DAMAGE OCCURRED TO THE CUSTOMER ON (B)(6) 2022 WHEN CATHETER WAS PULLED OUT. THE ABOVE-MENTIONED PATIENT UNDERWENT CARDIOSURGICAL OPERATION ON (B)(6) 2022. FOR THIS OPERATION, THE PATIENT WAS TO RECEIVE A NIAGARA CATHETER INTO THE LEFT INTERNAL JUGULAR VEIN. AFTER SONOGRAPHICALLY CONTROLLED SUCCESSFUL VENOUS PUNCTURE WITH SATURATED ASPIRATION, THE WIRE OF THE SAID SET WAS INSERTED VIA THE PUNCTURE NEEDLE OF THE PUNCTURE SET. AFTER ONLY A FEW CM IT WAS NO LONGER POSSIBLE TO ADVANCE THE WIRE, NOR WAS IT POSSIBLE TO RETRACT IT. THE WIRE COULD NO LONGER BE MOVED IN THE NEEDLE. THE NEEDLE INCLUDING THE WIRE WAS REMOVED FROM THE PATIENT. EVEN AFTER REMOVAL IT WAS NOT POSSIBLE TO MOVE THE WIRE INSIDE THE NEEDLE.

  Patient problems: Insufficient Information

  MAUDE report 14461898 ↗
• MalfunctionOct 27, 2021Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED AT 17:00, (B)(6) 2021, THE PATIENT WAS DIAGNOSED WITH KETOACIDOSIS ACCOMPANIED BY PANCREATITIS, AND DIALYSIS CATHETER PLACEMENT WAS PLANNED. HEMOPERFUSION + HEMODIALYSIS WAS PERFORMED, BUT THE CONNECTION BETWEEN DIALYSIS CATHETER AND SYRINGE WAS NOT TIGHT AND WATER LEAKAGE WAS FOUND DURING THE PLACEMENT OF DIALYSIS CATHETER. IMMEDIATELY REPLACE THE DIALYSIS CATHETER TO CONTINUE PLACEMENT, COMPLETE HEMOPERFUSION + HEMODIALYSIS TREATMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12704339 ↗
• MalfunctionJul 22, 2021Material Frayed; Material Frayed

  IT WAS REPORTED THAT THE PUNCTURE NEEDLE WAS IN PATIENT AND GUIDEWIRE WAS INTRODUCED. THEN THE PATIENT HAD TO BE MOVED SLIGHTLY IN ANOTHER POSITION. THEN GUIDEWIRE WAS STUCK IN PLACE AND REMOVAL WAS ONLY POSSIBLE WITH REMOVAL OF PUNCTURE NEEDLE. EVEN OUTSIDE THE BODY THE NEEDLE AND THE CATHETER COULD NOT BE SEPARATED. ON (B)(6) 2021 - RETURNED WIRE HAS A BROKEN CORE WIRE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12210698 ↗
• MalfunctionDec 23, 2020Difficult to Remove

  IT WAS REPORTED THAT THE GUIDE WIRE COULD NOT BE REMOVED ANYMORE FROM THE CANNULA (PUNCTURE NEEDLE). NO OTHER INFORMATION WAS PROVIDED. IT WAS REPORTED THIS EVENT OCCURRED TWICE. THIS REPORT ADDRESSES THE SECOND EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 11065236 ↗
• MalfunctionDec 23, 2020Difficult to Remove

  IT WAS REPORTED THAT THE GUIDE WIRE COULD NOT BE REMOVED ANYMORE FROM THE CANNULA (PUNCTURE NEEDLE). NO OTHER INFORMATION WAS PROVIDED. IT WAS REPORTED THIS EVENT OCCURRED TWICE. THIS REPORT ADDRESSES THE FIRST EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 11061886 ↗
• MalfunctionAug 29, 2019Material Frayed; Stretched; Material Frayed

  IT WAS REPORTED AN ELONGATION OF THE GUIDE DURING THE 2ND EXPANSION. NO OTHER INFORMATION PROVIDED.

  Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient

  MAUDE report 8946543 ↗
• MalfunctionAug 9, 2019Mechanics Altered; Physical Resistance/Sticking

  IT WAS REPORTED THAT WHEN THE GUIDE IS REMOVED, IT GOT "STUCK AND RELAXES".

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8879661 ↗
• MalfunctionOct 24, 2018Material Deformation

  IT WAS REPORTED THAT THE GUIDE WIRE HAD A KINK. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7999745 ↗
• MalfunctionApr 26, 2018Air Leak

  IT WAS REPORT THAT A PATIENT WAS RECEIVING CRRT, WITH A PRISMAFLEX CIRCUIT ,THROUGH THE NIAGARA DOUBLE LUMEN CATHETER. THE CATHETER WAS APPARENTLY IN THE RIGHT INTERNAL JUGULAR SITE. THE CRRT MACHINE ALLEGEDLY STARTED DRAWING IN AIR AT THE ACCESS SITE. THE NURSE CHECKED THE CONNECTION OF THE CRRT SET, ALL TUBING, AND THE CONNECTION AT THE SITE OF THE CATHETER. IT WAS STATED THAT THE MACHINE CONTINUED TO DRAW IN AIR THROUGH THE ACCESS SITE. THE NURSE REPLACED THE CRRT SET AND EXAMINED THE SET FOR ANY CONNECTION ISSUES OR FAULT IN THE TUBING. NO ALLEGED FAULTS WERE FOUND, NO CONNECTIONS APPEARED FAULTY. CRRT WAS RESTARTED, AND RAN SMOOTHLY FOR APPROX. 15 MINUTES, WHEN AIR STARTED TO BE DRAWN IN FROM THE ACCESS, AT THE LUMEN OF THE CATHETER. THE NURSE ALLEGEDLY OBSERVED AIR BUBBLING COMING FROM INSIDE THE CATHETER. THE CRRT TREATMENT HAD TO BE STOPPED AND THE NIAGARA CATHETER WAS REMOVED. ON 11-APR-18 ADDITIONAL INFORMATION: THERE WAS NO INJURY TO THE PATIENT AS THE NURSE ACTED TO PREVENT ANY INJURY. THE AIR WAS CAPTURED BY THE AERATION CHAMBER IN THE CRRT TUBING. FURTHER AIR ENTERED THE SYSTEM AND CRRT WAS DISCONTINUED. THE CATHETER WAS REMOVED. NO REPLACEMENT WAS DONE. THE PATIENT¿S

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7467278 ↗
• MalfunctionAug 24, 2016Difficult to Remove

  HEALTH PROFESSIONAL REPORTED THAT DURING INSERTION OF A SHELDON IN THE RIGHT INTERNAL JUGULAR VEIN, THE GUIDE IRE BECAME STUCK IN THE JUGULAR VEIN. STAFF HAD DIFFICULTY REMOVING THE GUIDEWIRE BUT WERE SUCCESSFUL AFTER 10 MINUTES OF TRYING TO REMOVE. PATIENT HAD A VENOUS COMPRESSION BUT NO HEMATOMA.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 5901444 ↗
• MalfunctionNov 6, 2015Break; Unraveled Material

  THE WIRE WAS ALLEGEDLY BROKEN AT TIP WITH THE COIL UNRAVELED. ALL PIECES OF THE WIRE WERE RECEIVED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 5208829 ↗