Power-Trialysis catheter 5618200Recalls & reported problems
Bard Access Systems, Inc. · 13Fr Trialysis PC 20cm Kit · Class 2
All models of Power-Trialysis catheter (22)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00801741041990), received between Mar 2, 2018 and Jan 20, 2026 — classified as 1 injury, 3 malfunctions.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (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
- Detachment of Device or Device Component1
- Failure to Infuse1
- Kinked1
- Material Frayed1
Patient problems
- No Clinical Signs, Symptoms or Conditions3
- Perforation of Vessels1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 20, 2026Material Frayed
IT WAS REPORTED THAT WHEN THE PACKAGING WAS OPENED IN THE HOSPITAL EMERGENCY ROOM FOR PRODUCT INSERTION, THE GUIDE WIRE WAS FOUND TO BE STRETCHED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24118129 ↗MalfunctionJan 27, 2022Detachment of Device or Device Component; Detachment of Device or Device Component
THE CUSTOMER REPORTS: ¿AT THE CONNECTION BETWEEN POWER TRIALYSIS AND THE MACHINE THE HUB IS UNSTABLE (NOT TIGHT). IT TWISTS AND THIS INCREASES THE ACCESS PRESSURE.¿ ADDITIONAL INFORMATION 1/18/2022: THE POWER TRIALYSIS 5618200 WITH THE LOT REFU1793 EXP. DATE 2023/03/31. THIS PRODUCT IS USED FOR HEMOFILTRATION AND WHEN THE CURVED LINE IS CONNECTED TO THE MACHINE, THE TUBING BECOMES VERY SOFT AND TWISTS IN SUCH A WAY THAT THE FLOW IS INTERRUPTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13374077 ↗MalfunctionMay 24, 2021Failure to Infuse; Failure to Infuse
IT WAS REPORTED THAT AFTER THE PROCEDURE, FLUSHING FAILED THROUGH THE CATHETER. THE CATHETER FUNCTION TEST FAILED. NO OTHER INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11872796 ↗InjuryMar 2, 2018Kinked
IT WAS REPORTED THAT THE WIRE KINKED DURING APPLICATION AND PERFORATED A VESSEL AS WELL AS THE LUNG.
Patient problems: Perforation of Vessels
MAUDE report 7310902 ↗
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.
How reports and recalls are matched · Editorial policy · Report an error on this page