Power-Trialysis catheter 5605200Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 00801741086960), received between Jul 11, 2019 and Aug 21, 2025 — classified as 1 death, 14 malfunctions.

The most frequently reported specific device problem is “Material Frayed” (3 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 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 21, 2025Product Quality Problem; Activation Problem; Product Quality Problem; Activation Problem

  IT WAS REPORTED BY THE CUSTOMER THAT THE NEEDLE DRIVER FOR POWER TRIALYSIS SHORT TERM STRAIGHT DIALYSIS KIT IS NOT CLAMPING, RESULTING IN FREQUENT LOOSE NEEDLES IN THE FIELD AND A HIGH RISK OF NEEDLESTICK INJURY. NO HARM TO PATIENT. NO FURTHER INFORMATION PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22865001 ↗
• MalfunctionMay 5, 2025Material Deformation; Material Deformation

  IT WAS REPORTED; DILATOR FRAYED AT THE END AND WILL NOT ADVANCE. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21965032 ↗
• DeathApr 23, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED, PATIENT REMOVED TRIALYSIS CATHETER THAT WAS PLACED IN FEMORAL VEIN AND BLED OUT. SUTUTRES WERE IN TACT ALONG WITH THE SUTURE WINGS BUT TRIALYSIS HAD BEEN PULLED THROUGH THE LOOP. PATIENT BLED OUT AND EXPIRED. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 21893687 ↗
• MalfunctionSep 6, 2024Contamination /Decontamination Problem; Contamination /Decontamination Problem

  IT WAS REPORTED THAT HAIR FOUND IN DIALYSIS KIT. HAD TO THROW THE KIT AWAY. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20158037 ↗
• MalfunctionMar 23, 2024Break; Break

  IT WAS REPORTED BY CUSTOMER THAT A KIT HAD BROKEN SALINE AMPULES AND RUST ON AN INSTRUMENT (POSSIBLY FROM THE LEAKED SALINE). CLINICIAN NOTICED THIS BEFORE STARTING THE PROCEDURE SO THIS EQUIPMENT WAS NOT USED ON THE PATIENT. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18965343 ↗
• MalfunctionFeb 7, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED, ¿HOLE IN DIALYSIS CATHETER. NOTICED LEAKAGE DURING DIALYSIS AND HAD TO REPLACE WITH NEW CATHETER.¿ NO OTHER INFORMATION WAS PROVIDED. IT WAS REPORTED THIS OCCURRED WITH (TWO) DEVICES. THIS REPORT ADDRESSES THE SECOND DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18664383 ↗
• MalfunctionFeb 7, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED, "HOLE IN DIALYSIS CATHETER. NOTICED LEAKAGE DURING DIALYSIS AND HAD TO REPLACE WITH NEW CATHETER". NO OTHER INFORMATION WAS PROVIDED. IT WAS REPORTED THIS OCCURRED WITH (TWO) DEVICES. THIS REPORT ADDRESSES THE FIRST DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18664257 ↗
• MalfunctionFeb 2, 2024Suction Problem; Suction Problem

  IT WAS REPORTED THE CATHETER THEY LEFT IN WOULD NOT DRAW BLOOD THROUGH THE CENTRAL PORT BUT REMAINED IN THE PATIENT. IT WAS STATED THERE WAS DIFFICULTY THREADING THE DEVICE. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18631626 ↗
• MalfunctionOct 18, 2022Failure to Infuse; Failure to Infuse

  IT WAS REPORTED BY THE CUSTOMER THAT " PATIENT'S TRIALYSIS CATHETER STOPPED WORKING DURING A RECIRCULATION." RESPONSE: EXPLAINED PER THE POWER TRIALYSIS WALL CHART UNDER TROUBLESHOOTING, "CATHETERS THAT PRESENT RESISTANCE TO FLUSHING AND ASPIRATION MAY BE PARTIALLY OR COMPLETELY OCCLUDED EXCESSIVE FORCE MUST NOT BE USED TO FLUSH AN OBSTRUCTED LUMEN. INSUFFICIENT BLOOD FLOW MAY BE CAUSED BY OCCLUDED HOLES RESULTING FROM A CLOT OR BY SIDE HOLES CONTACTING THE WALL OF THE VEIN. IF MANIPULATION OF THE CATHETER THROUGH ROTATION OR REVERSING ARTERIAL AND VENOUS LINES DOES NOT HELP, THEN THE PHYSICIAN MAY ATTEMPT TO DISSOLVE THE CLOT WITH A DECLOTTING PROCEDURE PER INSTITUTION PROTOCOL."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15629401 ↗
• MalfunctionSep 14, 2022Suction Problem; Suction Problem

  IT WAS REPORTED CLINICIAN WAS ABLE TO FLUSH THE CVC PORT BUT UNABLE TO CONSISTENTLY GET BLOOD RETURN. IT WAS STATED A NEW CATHETER WAS INSERTED WITHOUT ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15421981 ↗
• MalfunctionApr 22, 2022Material Frayed; Material Frayed

  IT WAS REPORTED VIA MEDWATCH "PROVIDER AND THE REGISTERED NURSE ATTEMPTED A RIGHT FEMORAL PLACEMENT OF THE POWER TRIALYSIS SHORT TERM STRAIGHT DIALYSIS CATHETER. THEY ABORTED THE ATTEMPT DUE TO EQUIPMENT FAILURE. WHILE TRYING TO PUT IN A POWER-TRIALYSIS CATHETER, THE GUIDE WIRE CAME APART, OUTSIDE OF THE PATIENT'S BODY (NOT INSIDE). THEY HAD TO STOP THE PROCEDURE BECAUSE THEY COULD NOT THREAD THE CATHETER OVER TO THE GUIDE WIRE. AT THAT POINT THERE WAS NOT HARM TO THE PATIENT OTHER THAN THE ABORTED ATTEMPT, AND SOME BLEEDING DURING THE PROCEDURE. THE WIRE WAS KEPT. TIME, DATE AND PATIENT LABEL WERE PLACED ON THE CLEAR PLASTIC BAG WITH THE GUIDEWIRE AND INTRODUCER CATHETER, THAT CAUSED THE FAILURE." ADD INFO RCVD 04/11/2022: PLACEMENT DATE: (B)(6) 2022, EXPLANT DATE: (B)(6) 2022.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14188590 ↗
• MalfunctionApr 6, 2022Material Frayed; Material Frayed

  IT WAS REPORTED VIA PHONE CALL "THE GUIDEWIRE BECAME STUCK IN DILATOR CATHETER AND IT BECAME STUCK IN THE TIP. THE GUIDEWIRE BECAME STUCK IN DILATOR CATHETER AND GUIDEWIRE TIP UNRAVELED. WHEN DILATOR WAS PULLED OUT OF PATIENT TO REMOVE DILATOR FROM OVER THE GUIDEWIRE TIP UNRAVELED. DILATOR WAS OUTSIDE OF PATIENT BODY WHEN WIRE WAS STUCK AND UNRAVELED."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14028451 ↗
• MalfunctionJun 23, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED VIA MEDWATCH "PATIENT WAS STABLE ON CRRT WHICH WAS CONNECTED TO A TRIALYSIS TRIPLE LUMEN DIALYSIS CATHETER PLACED IN HIS RIGHT INTERNAL JUGULAR VEIN. THE PRISMAFLEX MACHINE ALARMED AND THE RN FOUND THE RETURN LINE DISCONNECTED FROM THE PATIENT AND THE ALARM INDICATING AIR DETECTED. THE LINE FROM THE TRIPLE LUMEN AND CRRT MACHINE WERE IMMEDIATELY CLAMPED. CRRT MACHINE WAS STOPPED. THE RN THEN ASPIRATED AIR FROM THE PATIENT'S TRIPLE LUMEN. PATIENT DID NOT SUFFER ANY HARM FROM THE DISCONNECTION. PER FAMILY IN THE ROOM WHEN THE ALARM SOUNDED, THE PATIENT WAS STILL IN BED AND HAD NOT BEEN MOVING HIS HEAD OR UPPER BODY PRIOR TO THE DISCONNECTION. THE LINE WAS LEAKING AT THE JUNCTION BETWEEN THE CRRT TUBING AND THE PATIENT'S TRIPLE LUMEN CENTRAL LINE. BAXTER BIOMEDICAL ENGINEER EVALUATED THE CRRT MACHINE AND FOUND NO MALFUNCTIONS. DATA FROM THE MACHINE WAS DOWNLOADED BY A BAXTER EDUCATOR AND A SUMMARY REPORT FROM THEM IS PENDING AT THIS WRITING. BAXTER IS ACTIVELY INVOLVED IN THE INVESTIGATION FOR PNSMAFLEX SET."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12049789 ↗
• MalfunctionJan 17, 2020Material Frayed; Material Frayed

  IT WAS REPORTED "GUIDE WIRE UNRAVELED WHEN REMOVING GUIDE WIRE FROM CATHETER AFTER PLACED. THERE WAS NO RESISTANCE ADVANCING /PLACING THE GUIDE WIRE. MINIMAL RESISTANCE WHEN WIRE WAS REMOVED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9604547 ↗
• MalfunctionJul 11, 2019Defective Component; Therapeutic or Diagnostic Output Failure

  THE DOCTOR WAS PLACING A CENTRAL LINE IN AN ICU PATIENT. THE INCLUDED NEEDLE DRIVERS IN THE KIT WERE DEFECTIVE AND DID NOT WORK. THEY HAD TO GET ANOTHER SET IN ORDER TO COMPLETE THE PROCEDURE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8780110 ↗