Power-Trialysis catheter 5608300Recalls & reported problems
Bard Access Systems, Inc. · 13Fr Trialysis ST 30cm Tray · Class 2
All models of Power-Trialysis catheter (22)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00801741041921), received between May 2, 2023 and Feb 18, 2026 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Component Incompatible” (1 report).
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.
Reports received per month
Most reported problems
Device problems
- Component Incompatible1
- Defective Component1
- Fluid/Blood Leak1
Patient problems
- Insufficient Information1
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 18, 2026Fluid/Blood Leak
IT WAS REPORTED THIS OCCURRED WITH TWO DEVICES. THIS REPORT ADDRESSES BOTH DEVICES.
Patient problems: Insufficient Information
MAUDE report 24384164 ↗MalfunctionMay 2, 2023Component Incompatible; Defective Component; Component Incompatible; Defective Component
IT WAS REPORTED BY THE CUSTOMER "ON APRIL 6, THE COLLEAGUE WILL INSERT A BARD BRAND DIALYSIS CATHETER, POWER-TRIALYSIS 30 CM. THE GUIDE IS INSERTED INTO THE FEMORAL VEIN. THEN THE USUAL DILATATION WITH THE ACCOMPANYING DILATORS. IT IS NOT POSSIBLE TO INSERT THE DIALYSIS CATHETER ON THE GUIDE. THE DISTAL END OF THE GUIDE IS VERY SOFT, BUT WE SNAP IT OFF WITH A STERILE CUTTER AND THEN THE DIALYSIS CATHETER CAN BE THREADED OVER THE GUIDE WITH RESISTANCE. THE CATHETER IS VERY SLOW TO PASS OVER THE GUIDE. THE GUIDE CANNOT THEN BE BACKED OUT OF THE DIALYSIS CATHETER BUT ONLY GIVES A FAILING RESPONSE, SUCH AS THE GUIDE BEING STRETCHED. THE GUIDE AND CATHETER ARE THEN PULLED OUT AS ONE UNIT. THE PROCEDURE HAD TO BE STOPPED.". ADDITIONAL INFORMATION RECEIVED 17-APR-2023: IT WAS REPORTED BY BD REP, "THERE WAS NO PATIENT HARM.".
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16857567 ↗
Other CATHETER, HEMODIALYSIS, TRIPLE LUMEN, NON-IMPLANTED devices
- Power-Trialysis catheter 5605150Bard Access Systems, Inc. · CATHETER, HEMODIALYSIS, TRIPLE LUMEN, NON-IMPLANTED2 recalls13 reports
- Power-Trialysis catheter 5605240Bard Access Systems, Inc. · CATHETER, HEMODIALYSIS, TRIPLE LUMEN, NON-IMPLANTED2 recalls8 reports
- MAHURKAR 8888101002HPMozarc Medical US LLC · CATHETER, HEMODIALYSIS, TRIPLE LUMEN, NON-IMPLANTED2 recalls1 death8 reports
- Power-Trialysis Slim-Cath catheter 5855240Bard Access Systems, Inc. · CATHETER, HEMODIALYSIS, TRIPLE LUMEN, NON-IMPLANTED2 recalls4 reports
- Power-Trialysis catheter 5615200Bard Access Systems, Inc. · CATHETER, HEMODIALYSIS, TRIPLE LUMEN, NON-IMPLANTED2 recalls4 reports
- MAHURKAR 8888101003HPMozarc Medical US LLC · CATHETER, HEMODIALYSIS, TRIPLE LUMEN, NON-IMPLANTED2 recalls4 reports
- MAHURKAR 8888102003HPMozarc Medical US LLC · CATHETER, HEMODIALYSIS, TRIPLE LUMEN, NON-IMPLANTED2 recalls4 reports
- MAHURKAR 8888102004HPMozarc Medical US LLC · CATHETER, HEMODIALYSIS, TRIPLE LUMEN, NON-IMPLANTED2 recalls3 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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