Power-Trialysis catheter 5613240Recalls & reported problems
Bard Access Systems, Inc. · 13Fr Trialysis PC 24cm Kit · Class 2
All models of Power-Trialysis catheter (22)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 6
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00801741041969), received between Dec 21, 2018 and Nov 29, 2023 — classified as 6 malfunctions.
The most frequently reported specific device problem is “Fluid/Blood Leak” (6 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. 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
- Fluid/Blood Leak6
- Fracture1
Patient problems
- Hemorrhage/Blood Loss/Bleeding4
- No Consequences Or Impact To Patient1
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.
MalfunctionNov 29, 2023Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THAT IN THE LAST 3 WEEKS THERE HAVE BEEN 4 BLEEDING COMPLICATIONS. 2 DEVICES WERE USED IN THE SAME PATIENT. 2 OTHER PATIENTS HAD COMPLICATIONS, 1 DEVICE PER PATIENT. DEVICE IS NOT AVAILABLE FOR RETURN. THIS FILE ADDRESSES THE THIRD DEVICE.
Patient problems: Hemorrhage/Blood Loss/Bleeding
MAUDE report 18235106 ↗MalfunctionNov 29, 2023Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THAT IN THE LAST 3 WEEKS THERE HAVE BEEN 4 BLEEDING COMPLICATIONS. 2 DEVICES WERE USED IN THE SAME PATIENT. 2 OTHER PATIENTS HAD COMPLICATIONS, 1 DEVICE PER PATIENT. DEVICE IS NOT AVAILABLE FOR RETURN. THIS FILE ADDRESSES THE SECOND DEVICE USED ON PATIENT 1.
Patient problems: Hemorrhage/Blood Loss/Bleeding
MAUDE report 18235105 ↗MalfunctionNov 29, 2023Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THAT IN THE LAST 3 WEEKS THERE HAVE BEEN 4 BLEEDING COMPLICATIONS. 2 DEVICES WERE USED IN THE SAME PATIENT. 2 OTHER PATIENTS HAD COMPLICATIONS, 1 DEVICE PER PATIENT. DEVICE IS NOT AVAILABLE FOR RETURN. THIS FILE ADDRESSES THE FIRST DEVICE USED ON PATIENT 1.
Patient problems: Hemorrhage/Blood Loss/Bleeding
MAUDE report 18235103 ↗MalfunctionNov 29, 2023Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THAT IN THE LAST 3 WEEKS THERE HAVE BEEN 4 BLEEDING COMPLICATIONS. 2 DEVICES WERE USED IN THE SAME PATIENT. 2 OTHER PATIENTS HAD COMPLICATIONS, 1 DEVICE PER PATIENT. DEVICE IS NOT AVAILABLE FOR RETURN. THIS FILE ADDRESSES THE FOURTH DEVICE.
Patient problems: Hemorrhage/Blood Loss/Bleeding
MAUDE report 18235102 ↗MalfunctionDec 20, 2019Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED VIA MEDWATCH REPORT, "DIALYSIS CATHETER RUPTURED WHILE BEING INSERTED INTO THE PATIENT."
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9507189 ↗MalfunctionDec 21, 2018Fluid/Blood Leak; Fracture
IT WAS REPORTED BY MEDWATCH THAT: "TRIALYSIS CATHETER STARTED LEAKING FROM BLUE RETURN SIDE OF CATHETER DUE TO FRACTURE."
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8189399 ↗
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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