Power-Trialysis catheter 5615150Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00801741075094), received between Mar 16, 2016 and Nov 29, 2023 — classified as 2 deaths, 6 malfunctions.

The most frequently reported specific device problem is “Failure to Infuse” (2 reports).

1 FDA recall record name this device's identifier, 1 still open.

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.

Recalls naming this device

1. Aug 10, 2026Class IOpen, Classified

   this is a downstream recall of class I recall RES 98777

   Z-2984-2026 · Root cause: Material/Component Contamination · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• DeathNov 29, 2023Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  CUSTOMER INQUIRED ON ANY CHANGES IN DESIGN OR MANUFACTURING PROCESS FOR DEVICE. ADDITIONAL INFORMATION RECEIVED 11/6/2023: IT WAS REPORTED BY THE CUSTOMER "THE TWO PORTS AND THEIR RESPECTIVE LINES LEADING TO THE "Y" HUB (ARTERIAL AND VENOUS) BECAME DETACHED FROM THE HUB. THIS WAS A 79 YEAR OLD WHITE MALE PATIENT WEIGHING 77KG WITH A PMH SIGNIFICANT FOR LEUKEMIA AND GI NEUROENDOCRINE TUMOR WHO PRESENTED WITH WEAKNESS AND ENCEPHALOPATHY. HE DEVELOPED AKI WHICH REQUIRED DIALYSIS WITH CATHETER IN QUESTION. THE PATIENT CODED REQUIRING ACLS AND THE PATIENT EXPIRED." ADDITIONAL INFORMATION RECEIVED 11/30/2023: IT WAS REPORTED BY THE CUSTOMER ¿THE PATIENT WAS NOTED TO HAVE BEEN RESTING COMFORTABLY PRIOR TO THE CODE. HE DID HAVE DIALYSIS EARLIER IN THE DAY ~ 8 HOURS PRIOR TO CODE. THE TWO PORTS AND THEIR RESPECTIVE LINES LEADING TO THE "Y" HUB (ARTERIAL AND VENOUS) BECAME DETACHED FROM THE HUB. CAUSE OF DEATH WAS EXSANGUINATION FROM DETACHMENT OF THE DIALYSIS CATHETER. CODE EFFORTS RENDERED IMMEDIATELY UPON LOSS OF PULSES. ROSC NOT ACHIEVED. DEVICE WAS NOTED TO HAVE BEEN WORKING PROPERLY, SITE WAS CLEAN, DRY, AND INTACT. IT WAS NOTED THAT A TEGADERM WAS NOT BEING USED AT THE TIME OF THE EVE

  Patient problems: Exsanguination; Insufficient Information

  MAUDE report 18229401 ↗
• MalfunctionMay 2, 2023Component Incompatible; Component Incompatible

  PER MEDWATCH: GUIDEWIRE BECAME STUCK IN NEEDLE DURING SHORT TERM TRIAL CATHETER INSERTION. ADDITIONAL INFORMATION RECEIVED 02/28/2023: GUIDEWIRE WAS USED DURING AN INSERTION OF A TRIAL CATHETER FOR A PATIENT, IT BECAME STUCK IN NEEDLE DURING CATHETER INSERTION. NO PATIENT HARM REPORTED. (B)(6) 2023 ONE OF THE COILS OF THE COILED WIRE OF THE GUIDEWIRE WAS FOUND TO BE UNRAVELED NEAR THE DISTAL END OF THE GUIDEWIRE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16856817 ↗
• MalfunctionJan 13, 2023Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED BY THE CUSTOMER THAT LUMEN CRACKED APART IN THE CURVE SECTION OF THE LUMEN. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16158171 ↗
• MalfunctionFeb 16, 2022Failure to Infuse; Failure to Infuse

  IT WAS REPORTED A PATIENT HAS CLOTTED OFF TWO LINES IN THE LAST 12 HOURS SUSPECTED DUE TO THE LINE CURVING AND CAUSING A CLOT. NO OTHER INFORMATION WAS PROVIDED. THIS REPORT ADDRESSES THE SECOND DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13546049 ↗
• MalfunctionFeb 16, 2022Failure to Infuse; Failure to Infuse

  IT WAS REPORTED A PATIENT HAS CLOTTED OFF TWO LINES IN THE LAST 12 HOURS SUSPECTED DUE TO THE LINE CURVING AND CAUSING A CLOT. NO OTHER INFORMATION WAS PROVIDED. THIS REPORT ADDRESSES THE FIRST DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13546043 ↗
• MalfunctionMar 25, 2020Material Frayed; Material Frayed

  IT WAS REPORTED THAT THE MD WAS PLACING THE TRIALYSIS CATHETER AND WHEN THEY PULLED OUT THE WIRE IT LOOKED LIKE A SPRING AND WAS ALL CURLED UP. ADDENDUM PER RECEIVED EMAIL: "I WAS PLACING A DIALYSIS CATHETER FOR THIS PATIENT. WHILE PULLING THE WIRE, THE END OF IT BECAME LOOSE AND UNCOILED (LIKE A SPRING)."

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9879300 ↗
• MalfunctionAug 22, 2018Complete Blockage

  IT WAS REPORTED VIA MEDWATCH DESCRIPTION THAT THE "DIALYSIS CATHETER WAS BEING EXCHANGED BECAUSE IT HAD CLOTTED OFF. WHEN REMOVING THE CATHETER A BULGE WAS NOTED IN THE BLUE LUMEN LINE. IT APPEARS TO BE A WEAK POINT IN THE CATHETER LUMEN. POTENTIAL FOR MASSIVE BLEEDING IF LINE HAD RUPTURED."

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7807809 ↗
• DeathMar 16, 2016Insufficient Device Problem Information

  IT WAS REPORTED PER PHYSICIAN THAT THERE WAS A PATIENT DEATH WHILE USING THE POWER TRIALYSIS PRODUCT. THE PHYSICIAN WITNESSED THE DEATH ASSOCIATED WITH THE INSERTION OF A POWERTRIALYSIS AND FEELS THAT THE DILATORS ARE TOO LONG.

  Patient problems: Death

  MAUDE report 5504030 ↗