Power-Trialysis catheter 5608200Recalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 00801741041907), received between May 24, 2017 and Dec 19, 2025 — classified as 1 injury, 15 malfunctions.

The most frequently reported specific device problem is “Break” (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 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 19, 2025Material Deformation; Material Deformation

  IT WAS REPORTED DURING INSERTION, THE GUIDE WIRE BECAME TWISTED, AND CATHETER INSERTION WAS THEN IMPOSSIBLE. NO INTERVENTION NEEDED, NO PATIENT HARM. IT WAS REPORTED THIS OCCURRED WITH FOUR DEVICES. THIS REPORT ADDRESSES ALL FOUR DEVICES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23850251 ↗
• MalfunctionNov 18, 2024Suction Problem; Suction Problem

  IT WAS REPORTED FAULTY INTRODUCER NEEDLE. USED ANOTHER SET. DR COULDN'T INSERT DIALYSIS CATHETER BECAUSE OF FAULTY NEEDLE. SUCKING AIR UNABLE TO ASPIRATE AS PER PROCEDURE. THE INTRODUCER NEEDLE HAS BEEN DISCARDED AS IT WAS FULL OF BLOOD. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20711694 ↗
• InjuryApr 22, 2022Material Frayed; Migration or Expulsion of Device; Material Frayed; Migration or Expulsion of Device

  IT WAS REPORTED THAT THE OPERATING SURGEON INSERTED CATHETER AND REMOVED GUIDEWIRE. DURING LOCATING THE CATHETER THROUGH CHEST AP, IT WAS NOTICED THAT THE TIP OF GUIDEWIRE IS NOT REMOVED, SO SURGEON REMOVED THE CATHETER AND THE BROKEN TIP OF GUIDEWIRE WAS RETRIEVED AS WELL. AFTER THE SURGERY, PATIENT PASSED AWAY DUE TO DETERIORATED COMPLICATIONS. PATIENT HAD SEVERAL PAST MEDICAL HISTORIES, AND ASPIRATION PNEUMONIA WAS IMPLANTED. ADDITIONAL INFORMATION: DID THE RETAINED WIRE CAUSE OR CONTRIBUTE TO THE PATIENT¿S DEATH? NO. IT WAS INFORMED FROM CUSTOMER THAT PATIENT PASSED AWAY BECAUSE OF PATIENT¿S UNDERLYING DISEASES. WAS THE BROKEN TIP OF THE GUIDEWIRE STUCK IN THE CATHETER OR WAS THE BROKEN TIP OF THE GUIDEWIRE IN THE PATIENT¿S BODY (OUTSIDE OF THE CATHETER)? PATIENT BP DROPPED WHILE GUIDEWIRE INSERTING, SO THEY TRIED TO REMOVE THE GUIDEWIRE, IN THIS PROCESS THE GUIDE WIRE BROKEN OFF WHILE REMOVING THE GUIDE WIRE. ARE THE CHEST AP IMAGES AVAILABLE? WAS THERE ANY OTHER IMAGING TAKEN, IF YES, ARE THE IMAGES AVAILABLE? UNKNOWN. I REQUESTED SOME IMAGES FILE BUT REJECTED FROM HOSPITAL. WHAT WAS THE DATE OF THE PATIENT DEATH? (B)(6) 2022. CUSTOMER INFORMED THAT PATIENT PASSED AWAY ON THE

  Patient problems: Foreign Body In Patient

  MAUDE report 14189944 ↗
• MalfunctionDec 3, 2021Material Deformation; Material Deformation

  IT WAS REPORTED ICU PHYSICIANS ARE COMPLAINING OF THE BAD QUALITY OF POWER TRIALYSIS SHORT TERM STRAIGHT DIALYSIS CATHETER. THE GUIDE WIRE IS TWISTING DURING INSERTION AND IT ALSO STUCK TO THE VEIN AND THE PHYSICIAN HAD TO REMOVE BOTH THE WIRE AND THE CATHETER FOR PATIENT SAFETY ISSUES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12924849 ↗
• MalfunctionSep 1, 2021Material Deformation; Material Deformation

  IT WAS REPORTED "SHE WAS INFORMED THAT WHEN DR TRIED INSERTING THE ACCESS NEEDLE, IT BROKE. THEY HAD TO OPEN ANOTHER KIT. I HAVE NO EXTRA INFORMATION AND AM STILL TRYING TO FIND MORE OUT. DR WAS THE PLACING DR. NOTHING WAS WRONG WITH THE CATHETER, ONLY THE NEEDLE."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12410807 ↗
• MalfunctionDec 23, 2020Break; Material Twisted/Bent

  IT WAS REPORTED BY THE ICU TODAY (B)(6) 2020 A PROBLEM WAS OBSERVED WITH THE WIRE: DIALYSIS CATHETER 3LUMEN 13FR / 20CM (LOT: REER0546, REF: 5608200). THE GUIDEWIRE IS WEAK, IT BENDS EASILY AND IN THE ATTEMPT TO PUSH THE INNER WIRE BROKE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 11067923 ↗
• MalfunctionMar 19, 2020Material Deformation; Material Deformation

  IT WAS REPORTED THAT AFTER PUNCTURING THE VESSEL THE WIRE TWISTED AND THE CATHETER COULDN´T BE INSERTED, REQUIRING THE PATIENT BE PUNCTURED AND CANNULATED AGAIN. IT WAS STATED THIS HAPPENED IN TWO CASES WITH THE SAME BATCH. NO OTHER INFORMATION WAS PROVIDED. THIS REPORT ADDRESSES THE FIRST OF TWO CASES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9857663 ↗
• MalfunctionMar 19, 2020Material Deformation; Material Deformation

  IT WAS REPORTED THAT AFTER PUNCTURING THE VESSEL THE WIRE TWISTED AND THE CATHETER COULDN´T BE INSERTED, REQUIRING THE PATIENT BE PUNCTURED AND CANNULATED AGAIN. IT WAS STATED THIS HAPPENED IN TWO CASES WITH THE SAME BATCH. NO OTHER INFORMATION WAS PROVIDED. THIS REPORT ADDRESSES THE SECOND OF TWO CASES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9857662 ↗
• MalfunctionJan 23, 2020Fluid/Blood Leak; Material Deformation; Fluid/Blood Leak; Material Deformation

  IT WAS REPORTED THAT "TROUBLE-FREE DIALYSIS CATHETER INSERT. AFTER HEMODIAFILTRATION, RECURRENT ALARM DUE TO REPEATED (BUBBLES CLEARLY VISIBLE) AIR IN THE ASPIRATING (RED) LEG. CATHETER WAS CHANGED AND THEN TESTED WITH AIR. A BLISTER FORMED AT THE BASE OF THE RED CATHETER LEG TO THE WHITE CONNECTING PART. POSSIBLE CONSEQUENCES: POTENTIAL AIR EMBOLISM POSSIBLE"

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9624853 ↗
• MalfunctionJun 7, 2018Break; Detachment Of Device Component; Kinked; Failure to Advance

  IT WAS REPORTED THAT A DIALYSIS CATHETER WAS INSERTED IN A PATIENT AND THERE WAS DIFFICULTY IN ADVANCING THE GUIDEWIRE. THE WIRE COULD NOT BE ADVANCED AND KINKED SEVERAL TIMES. AS USUAL, THE VEIN WAS PUNCTURED, WIRE INSERTED WITHOUT RESISTANCE, NEEDLE REMOVED AND DILATED. THE PROBLEM WAS ALLEGEDLY WITH INSERTION FROM THE CATHETER, THERE WAS A REPORTEDLY GREATER RESISTANCE AND COULD NOT BE ADVANCED. THEREUPON THE INSERT WAS BROKEN OFF AND THE WIRE WAS REMOVED. WHEN REMOVING IT HAS BEEN NOTICED THAT THE WIRE WAS KINKED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7578083 ↗
• MalfunctionMar 1, 2018Sticking

  IT WAS REPORTED THAT THE USER INSERTED THE WIRE AND THE CATHETER. IT WAS STATED THAT WHEN TRYING TO PULL THE WIRE OUT IT WAS NOT POSSIBLE BECAUSE THE WIRE GOT CAUGHT IN THE CATHETER. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7308232 ↗
• MalfunctionSep 22, 2017Break

  THE DOCTOR REPORTED THE HUB BROKE OFF UPON THE CATHETER INSERTION. NO PATIENT INJURY WAS REPORTED. THIS FILE ADDRESSED THE SECOND DEVICE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6886468 ↗
• MalfunctionSep 22, 2017Break

  THE DOCTOR REPORTED THE HUBS BROKE OFF UPON THE CATHETER INSERTION. NO REPORTED PATIENT INJURY. THIS FILE ADDRESSES THE SECOND DEVICE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6886464 ↗
• MalfunctionSep 22, 2017Break

  THE DOCTOR REPORTED THE HUB BROKE OFF UPON THE CATHETER INSERTION. NO PATIENT INJURY WAS REPORTED. THIS FILE ADDRESSED THE INITIAL DEVICE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6886449 ↗
• MalfunctionSep 22, 2017Break

  THE DOCTOR REPORTED THE HUBS BROKE OFF UPON THE CATHETER INSERTION. NO REPORTED PATIENT INJURY. THIS FILE ADDRESSES THE INITIAL DEVICE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6886294 ↗
• MalfunctionMay 24, 2017Retraction Problem

  IT WAS REPORTED THAT WHEN USING A POWERTRIALYSIS, THE WIRE COULD NOT BE RETRACTED AND PHYSICIAN HAD TO REMOVE THE COMPLETE CATHETER AGAIN.

  Patient problems: No Information

  MAUDE report 6588646 ↗