Power-Trialysis catheter 5613150Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 00801741041945), received between Apr 13, 2018 and Jun 24, 2025 — classified as 1 injury, 12 malfunctions.

The most frequently reported specific device problem is “Material Frayed” (5 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 24, 2025Material Frayed; Material Frayed

  IT WAS REPORTED THAT DURING A TRIALYSIS INSERTION THE GUIDEWIRE HAD SEPARATED. THE WIRE BEGAN TO SEPARATE WHEN THE VASCATH HAD ALREADY BEEN ADVANCED OVER THE WIRE, DURING REMOVAL THE PROVIDER NOTED RESISTANCE AND WHAT APPEAR TO BE SHEARING. HE STOPPED PULLING THE WIRE AND REMOVED VASCATH AND WIRE IN ITS ENTIRETY. THE PATIENT WAS NOT INJURED. NO REPORTED COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22323040 ↗
• InjuryJun 20, 2025Material Frayed; Material Frayed

  IT WAS REPORTED BY MEDWATCH, GUIDEWIRE TIP FRAGMENT FOUND AFTER CENTRAL LINE PLACEMENT FAILURE. THIN LINEAR DENSITY MEASURING APPROXIMATELY 1.8CM, PRESUMED GUIDEWIRE TIP, IS SEEN WITHIN THE RIGHT TRANSVERSE FOREMAN OF C6 EXTENDING TO THE RIGHT NEURAL FORAMINA OF C6-C7, POSSIBLY WITHIN THE RIGHT VERTEBRAL ARTERY VERSUS VERTEBRAL VENOUS PLEXUS. TWO ADDITIONAL PUNCTUATE HYPER DENSITY IS NOTES IN THE SVC, POSSIBLY A GUIDEWIRE FRAGMENT. CATHETER WAS REMOVED, AND A NEW ONE WAS PLACED. PATIENT DID NOT HAVE NAY SYMPTOMS RELATED TO THE RETAINED GUIDEWIRE FRAGMENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 22301627 ↗
• MalfunctionMar 31, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED BY MEDSUN, A HOLE WAS DISCOVERED IN THE BLUE LUMEN OF A DIALYSIS CATHETER WHILE INSERTED IN A PATIENT. THE CATHETER WAS REMOVED WITH NO HARM OR COMPLICATIONS TO THE PATIENT AND A NEW DIALYSIS LINE WAS REPLACED. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21734315 ↗
• MalfunctionMar 7, 2025Component Incompatible; Defective Component; Component Incompatible; Defective Component

  IT WAS REPORTED BY CUSTOMER THAT THE CENTRAL IR HAD A 13F X 15CM TRIALYSIS CATHETER MALFUNCTION OVER THE WEEKEND WHERE THE WIRE GOT STUCK IN THE PATIENT AND WAS HARD TO PULL OUT. THE TEAM ENDED UP NOT USING THE CATHETER ON THE PATIENT SO THERE WAS NO HARM TO THE PATIENT AT ALL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21552147 ↗
• MalfunctionFeb 23, 2024Component Incompatible; Component Incompatible

  IT WAS REPORTED BY MEDWATCH THAT EITHER THE OPENING AT THE DISTAL END OF THE CATHETER IS TOO SMALL, OR THE GUIDEWIRE IS UNRAVELING/FRAYED. THE TEAM DID NOT KEEP AN EXAMPLE. THE CATHETER WON'T THREAD ALL THE WAY DOWN THE GUIDEWIRE, AND THE GUIDEWIRE CANNOT BE REMOVED FROM THE PATIENT ONCE THE CATHETER IS POSITIONED. ADDITIONAL INFORMATION RECEIVED 2/9/2024: IT WAS REPORTED BY THE CUSTOMER THERE WAS NO PATIENT HARM OR NEGATIVE OUTCOME. A NEW KIT WAS OBTAINED AND A FRESH GUIDEWIRE AND CATHETER WERE USED TO COMPLETE THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18773340 ↗
• MalfunctionJan 30, 2024

  EITHER THE OPENING AT THE DISTAL END OF THE CATHETER IS TOO SMALL, OR THE GUIDEWIRE IS UNRAVELING/FRAYED. THE TEAM DID NOT KEEP AN EXAMPLE. THE CATHETER WON'T THREAD ALL THE WAY DOWN THE GUIDEWIRE, AND THE GUIDEWIRE CANNOT BE REMOVED FROM THE PATIENT ONCE THE CATHETER IS POSITIONED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18606569 ↗
• MalfunctionOct 11, 2023Material Frayed; Material Frayed

  IT WAS REPORTED THAT DURING INSERTION OF POWER TRIALYSIS SHORT-TERM CURVED EXTENSION DIALYSIS CATHETER, THE CATHETER GOT HUNG UP ON THE GUIDEWIRE DURING THE NORMAL EXCHANGE. INITIALLY, PROVIDER THOUGHT THERE WAS A PROBLEM WITH THE CATHETER, LEFT THE GUIDEWIRE IN PLACE AND REQUESTED A SECOND CATHETER. THE SECOND CATHETER ALSO HUNG UP ON THE GUIDEWIRE IN THE SAME WAY AS THE FIRST CATHETER. UPON FURTHER INSPECTION, THE GUIDEWIRE IS FRAYED AT THE DISTAL END. NO IMMEDIATE HARM TO PATIENT DETECTED. DEVICE WAS DISCARDED AFTER EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17912004 ↗
• MalfunctionOct 10, 2023Material Frayed; Material Frayed

  IT WAS REPORTED THAT DURING INSERTION OF POWER TRIALYSIS SHORT-TERM CURVED EXTENSION DIALYSIS CATHETER, THE CATHETER GOT HUNG UP ON THE GUIDEWIRE DURING THE NORMAL EXCHANGE. INITIALLY, PROVIDER THOUGHT THERE WAS A PROBLEM WITH THE CATHETER, LEFT THE GUIDEWIRE IN PLACE AND REQUESTED A SECOND CATHETER. THE SECOND CATHETER ALSO HUNG UP ON THE GUIDEWIRE IN THE SAME WAY AS THE FIRST CATHETER. UPON FURTHER INSPECTION, THE GUIDEWIRE IS FRAYED AT THE DISTAL END. NO IMMEDIATE HARM TO PATIENT DETECTED. IT WAS REPORTED BY THE CUSTOMER THIS OCCURRED SEVERAL TIMES HOWEVER THE EXACT QUANTITY WAS NOT PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17909560 ↗
• MalfunctionMay 26, 2023Material Frayed; Material Deformation; Material Frayed; Material Deformation

  IT WAS REPORTED BY THE CUSTOMER THAT DURING INSERTION OF POWER TRIALYSIS SHORT-TERM CURVED EXTENSION DIALYSIS CATHETER, THE CATHETER GOT HUNG UP ON THE GUIDEWIRE DURING THE NORMAL EXCHANGE. INITIALLY, PROVIDER THOUGHT THERE WAS A PROBLEM WITH THE CATHETER, LEFT THE GUIDEWIRE IN PLACE AND REQUESTED A SECOND CATHETER. THE SECOND CATHETER ALSO HUNG UP ON THE GUIDEWIRE IN THE SAME WAY AS THE FIRST CATHETER. UPON FURTHER INSPECTION, THE GUIDEWIRE IS FRAYED AT THE DISTAL END. NO IMMEDIATE HARM TO PATIENT DETECTED. NO OTHER INFORMATION WAS PROVIDED. ADDITIONAL INFORMATION RECEIVED 05/18/2023: THE EVENT OCCURRED DURING A NON-EMERGENT TRIALYSIS CATHETER INSERTION FOR RENAL REPLACEMENT THERAPY. EVENT DISCOVERED THE INSERTING PROVIDER NOTED THE FRAYED GUIDEWIRE WHILE ATTEMPTING TO REMOVE THE GUIDEWIRE AFTER THREADING THE CATHETER INTO PLACE. THE WIRE REMAINED IN 1 PIECE, NO FRAGMENTS NOTED. NO COMPLICATIONS NOTED. NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17011609 ↗
• MalfunctionFeb 27, 2019Material Split, Cut or Torn

  IT WAS REPORTED FROM THE FACILITY THAT THE DOCTOR AND THE SCRUB "WENT TO PUT THE CATHETER OVER THE WIRE AND IT WENT A COUPLE CM'S AND IT WAS LIKE IT HIT SOMETHING THAT DIDN'T ALLOW TO ADVANCE TO PATIENT." THIS HAPPENED TWICE IN THE SAME DAY. THE FACILITY OPENED ANOTHER 15CM CATHETER WITH A DIFFERENT LOT NUMBER. THIS REPORT ADDRESSES THE FIRST CATHETER.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8375448 ↗
• MalfunctionFeb 27, 2019Material Split, Cut or Torn

  IT WAS REPORTED THAT THE CATHETER TORE. IT WAS STATED THAT THIS HAPPENED WITH TWO CATHETERS. NO OTHER INFORMATION WAS PROVIDED. THIS REPORT ADDRESSES THE SECOND CATHETER.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8375439 ↗
• MalfunctionAug 9, 2018Leak/Splash

  IT WAS REPORTED THAT THE LINE WAS IN LESS THAN 24 HOURS BEFORE IT WAS FOUND TO BE LEAKING WHERE THE CATHETER MEETS THE HUB OF THE BIFURCATION. THE LINE WAS PULLED AND ANOTHER 24 CM CATHETER WAS PLACED. THE PATIENT REFERENCES TWO 24 CM CATHETERS BEING PLACED, YET THE PRODUCT INFORMATION PROVIDED FOR THE FIRST/DEFECTIVE DEVICE INDICATES A 15CM CATHETER; THAT INCONSISTENCY REMAINS AS NO FURTHER CLARIFICATION HAS BEEN PROVIDED AT THIS TIME. NO PATIENT INJURY INDICATED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7770625 ↗
• MalfunctionApr 13, 2018Connection Problem

  IT WAS REPORTED THAT WHILE THEY WERE PREPPING A CATHETER FOR A PATIENT, THEY NOTICED THAT THE LUER ON THE PICC LINE WAS OVAL IN SHAPE AND IT COULD NOT BE CONNECTED TO THE TUBING. ANOTHER DEVICE WAS USED AND PLACEMENT WAS SUCCESSFUL. NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 7430206 ↗