Power-Trialysis catheter 5603150Recalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 00801741041853), received between Oct 27, 2015 and Jun 19, 2023 — classified as 1 death, 1 injury, 15 malfunctions.

The most frequently reported specific device problem is “Difficult to Remove” (4 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 19, 2023Component Incompatible; Component Incompatible

  IT WAS REPORTED BY CUSTOMER THAT THE GUIDEWIRE IN THE TEMP HD CATH VERY DIFFICULT/NOT ABLE TO THREAD THROUGH THE LINE. CLINICIAN HAD TO OPEN A SECOND KIT. EVENT DIRECTLY INVOLVED A PATIENT FOR AN URGENT MEDICAL SITUATION. NO HARM OR INJURY. DELAY IN INSERTION CAUSED DELAY IN DIALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17152151 ↗
• MalfunctionJun 13, 2023Component Incompatible; Component Incompatible

  IT WAS REPORTED BY CUSTOMER THAT THE GUIDEWIRE IN THE TEMP HD CATH VERY DIFFICULT/NOT ABLE TO THREAD THROUGH THE LINE. CLINICIAN HAD TO OPEN A SECOND KIT. ADDITIONAL INFORMATION RECEIVED MAY 31, 2023. EVENT DIRECTLY INVOLVED A PATIENT FOR AN URGENT MEDICAL SITUATION. NO HARM OR INJURY. DELAY IN INSERTION CAUSED DELAY IN DIALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17122100 ↗
• MalfunctionDec 8, 2022Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THE "TRIALYSIS CATHETER WOULD NOT MAKE THE TURN INTO THE SVC AND WAS UP AGAINST A VESSEL WALL AND WOULD NOT FLOW CORRECTLY AND THE WALL OBSTRUCTED DIALYSIS PROCEDURE."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15946825 ↗
• MalfunctionJun 21, 2019Device Dislodged or Dislocated

  IT WAS REPORTED VIA MEDWATCH THAT THE SECUREMENT ON THE DEVICE ALLOWS IT TO MOVE WITHIN THE VESSEL AND CAME OUT OF THE VESSEL. PATIENT WAS RECEIVING CRRT WHEN LINE CAME OUT. RN WAS GIVING MEDICATION FOR PROCEDURE AND LINE HAD COME OUT. NEW LINE WAS PLACED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8723350 ↗
• MalfunctionAug 24, 2018Difficult to Open or Remove Packaging Material

  IT HAS BEEN REPORTED THAT THE TRIALYSIS PACKAGING IS "VERY FRUSTRATING TO WORK WITH." THE REPORTER STATES THAT THE PACKAGES ARE EXTREMELY TIGHT FITTING AND THEY DON¿T PEEL BACK SO THE DOCTORS HAVE TO CUT THE PACKAGING TO RELEASE THE INTERIOR PACKAGE. THIS ALSO COMPROMISES THE STERILITY BECAUSE THEY THEN EMPTY THE CONTENTS OUT INTO THE STERILE FIELD. IT WAS STATED THE LAST 4 INSERTIONS HAVE BEEN THIS WAY FOR THIS FACILITY. IT WAS ADDITIONALLY STATED THAT, "WE LITERALLY COULDN¿T PULL THE INTERIOR PACKAGE OUT EVEN WITH TWO PEOPLE TRYING." NO PATIENT INVOLVEMENT. THIS REPORT ADDRESSES THE THIRD EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7813927 ↗
• MalfunctionAug 24, 2018Difficult to Open or Remove Packaging Material

  IT HAS BEEN REPORTED THAT THE TRIALYSIS PACKAGING IS "VERY FRUSTRATING TO WORK WITH." THE REPORTER STATES THAT THE PACKAGES ARE EXTREMELY TIGHT FITTING AND THEY DON¿T PEEL BACK SO THE DOCTORS HAVE TO CUT THE PACKAGING TO RELEASE THE INTERIOR PACKAGE. THIS ALSO COMPROMISES THE STERILITY BECAUSE THEY THEN EMPTY THE CONTENTS OUT INTO THE STERILE FIELD. IT WAS STATED THE LAST 4 INSERTIONS HAVE BEEN THIS WAY FOR THIS FACILITY. IT WAS ADDITIONALLY STATED THAT, "WE LITERALLY COULDN¿T PULL THE INTERIOR PACKAGE OUT EVEN WITH TWO PEOPLE TRYING." NO PATIENT INVOLVEMENT. THIS REPORT ADDRESSES THE FOURTH EVENT.

  Patient problems: No Patient Involvement

  MAUDE report 7813926 ↗
• MalfunctionAug 24, 2018Difficult to Open or Remove Packaging Material

  IT HAS BEEN REPORTED THAT THE TRIALYSIS PACKAGING IS "VERY FRUSTRATING TO WORK WITH." THE REPORTER STATES THAT THE PACKAGES ARE EXTREMELY TIGHT FITTING AND THEY DON¿T PEEL BACK SO THE DOCTORS HAVE TO CUT THE PACKAGING TO RELEASE THE INTERIOR PACKAGE. THIS ALSO COMPROMISES THE STERILITY BECAUSE THEY THEN EMPTY THE CONTENTS OUT INTO THE STERILE FIELD. IT WAS STATED THE LAST 4 INSERTIONS HAVE BEEN THIS WAY FOR THIS FACILITY. IT WAS ADDITIONALLY STATED THAT, "WE LITERALLY COULDN¿T PULL THE INTERIOR PACKAGE OUT EVEN WITH TWO PEOPLE TRYING." NO PATIENT INVOLVEMENT. THIS REPORT ADDRESSES THE SECOND EVENT.

  Patient problems: No Patient Involvement

  MAUDE report 7813920 ↗
• MalfunctionAug 24, 2018Fitting Problem

  IT HAS BEEN REPORTED THAT THE TRIALYSIS PACKAGING IS "VERY FRUSTRATING TO WORK WITH." THE REPORTER STATES THAT THE PACKAGES ARE EXTREMELY TIGHT FITTING AND THEY DON¿T PEEL BACK SO THE DOCTORS HAVE TO CUT THE PACKAGING TO RELEASE THE INTERIOR PACKAGE. THIS ALSO COMPROMISES THE STERILITY BECAUSE THEY THEN EMPTY THE CONTENTS OUT INTO THE STERILE FIELD. IT WAS STATED THE LAST 4 INSERTIONS HAVE BEEN THIS WAY FOR THIS FACILITY. IT WAS ADDITIONALLY STATED THAT, "WE LITERALLY COULDN'T PULL THE INTERIOR PACKAGE OUT EVEN WITH TWO PEOPLE TRYING." NO PATIENT INVOLVEMENT. THIS REPORT ADDRESSES THE FIRST EVENT.

  Patient problems: No Patient Involvement

  MAUDE report 7813919 ↗
• MalfunctionAug 16, 2018Melted; Difficult to Remove; Physical Resistance/Sticking

  IT WAS REPORTED THAT TWO CATHETERS WERE OPENED AND THE CATHETER WAS GLUED / MELTED / STUCK AND COULD NOT BE REMOVED FROM THE PACKAGING STERILELY. THIS REPORT ADDRESSES THE SECOND CATHETER.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7792001 ↗
• MalfunctionAug 16, 2018Melted; Difficult to Remove; Physical Resistance/Sticking

  IT WAS REPORTED THAT TWO CATHETERS WERE OPENED AND THE CATHETER WAS GLUED / MELTED / STUCK AND COULD NOT BE REMOVED FROM THE PACKAGING STERILELY. THIS REPORT ADDRESSES THE FIRST CATHETER.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7791969 ↗
• MalfunctionAug 16, 2018Melted; Difficult to Remove; Physical Resistance/Sticking

  IT WAS REPORTED THAT TWO CATHETERS WERE OPENED AND THE CATHETER WAS GLUED / MELTED / STUCK AND COULD NOT BE REMOVED FROM THE PACKAGING STERILELY. THIS REPORT ADDRESSES THE FIRST CATHETER.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7790829 ↗
• MalfunctionAug 16, 2018Difficult to Remove; Physical Resistance/Sticking

  IT WAS REPORTED THAT TWO CATHETERS WERE OPENED AND THE CATHETER WAS GLUED / MELTED / STUCK AND COULD NOT BE REMOVED FROM THE PACKAGING STERILELY. THIS REPORT ADDRESSES THE SECOND CATHETER.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7790823 ↗
• InjuryMay 4, 2018Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THERE WAS PATIENT HARM OF AN AIR EMBOLISM. IT WAS STATED THAT IT MAY HAVE OCCURRED DURING FLUSHING, OR IMMEDIATELY AFTER. CONTACT STATED THAT NOTHING ACTED OUT OF THE ORDINARY WITH THE DEVICE, IT SEEMED TO FUNCTION AS IT SHOULD HAVE.

  Patient problems: Air Embolism

  MAUDE report 7487330 ↗
• MalfunctionApr 7, 2017Failure to Advance; Material Deformation

  IT WAS REPORTED BY THE FACILITY TO THE TM THAT WHEN INSERTING THE PURPLE TIP OF THE CATHETER UNDER FLUOROSCOPY, IT CRUMPLED AND WOULD NOT ADVANCE. NO REPORTED HARM TO PATIENT. THIS FILING COVERS THE THIRD EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6471878 ↗
• MalfunctionApr 7, 2017Failure to Advance; Material Deformation

  IT WAS REPORTED BY THE FACILITY TO THE TM THAT WHEN INSERTING THE PURPLE TIP OF THE CATHETER UNDER FLUOROSCOPY, IT CRUMPLED AND WOULD NOT ADVANCE. NO REPORTED HARM TO PATIENT. THIS FILING COVERS THE SECOND EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6471814 ↗
• MalfunctionApr 7, 2017Failure to Advance; Physical Property Issue

  IT WAS REPORTED BY THE FACILITY TO THE TM THAT WHEN INSERTING THE PURPLE TIP OF THE CATHETER UNDER FLUOROSCOPY, IT CRUMPLED AND WOULD NOT ADVANCE. NO REPORTED HARM TO PATIENT. THIS FILING COVERS THE FIRST EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6471812 ↗
• DeathOct 27, 2015Improper or Incorrect Procedure or Method; Cut In Material

  ON (B)(6) 2015, THE DIALYSIS CATHETER, ALPHACURVE TYPE (15 CM) WAS REPORTEDLY PLACED VIA THE RIGHT INTERNAL JUGULAR VEIN. THAT NIGHT THE PATIENT REPORTEDLY CUT THE CATHETER BY HIMSELF AND WAS REPORTEDLY FOUND DECEASED THE NEXT MORNING.

  Patient problems: Death

  MAUDE report 5182036 ↗