Power-Trialysis catheter 5615200Recalls & reported problems
Bard Access Systems, Inc. · 13Fr Trialysis PC 20cm Tray · Class 2
All models of Power-Trialysis catheter (22)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
2 open recalls name this device. See the recall details and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 2
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00801741075100), received between Nov 3, 2015 and Jun 25, 2025 — classified as 1 injury, 3 malfunctions.
The most frequently reported specific device problem is “Activation Problem” (1 report).
2 FDA recall records name this device's identifier, 2 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.
Reports received per month
Recalls naming this device
- 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 ↗
- May 21, 2026Class IIOpen, Classified
Due to lidocaine ampoules being manufactured under deficient manufacturing practices by manufacturer, lidocaine ampoules are currently being recalled by supplier.
Z-2660-2026 · Root cause: Nonconforming Material/Component · Recall details · FDA record ↗
Most reported problems
Device problems
- Activation Problem1
- Break1
- Material Deformation1
- Split1
Patient problems
- Hemorrhage/Blood Loss/Bleeding1
- Injury1
- Laceration(s)1
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
InjuryJun 25, 2025Break; Break
IT WAS REPORTED BY CUSTOMER THAT DIALYSIS CATHETER DISASSEMBLY. PATIENT BLOOD LOSS - CLINICIAN HELD PRESSURE FOR 2 HOURS TO STOP THE BLEEDING.
Patient problems: Hemorrhage/Blood Loss/Bleeding
MAUDE report 22330522 ↗MalfunctionAug 31, 2022Material Deformation; Material Deformation
IT WAS REPORTED "DILATOR ON HD CATHETER CRUMPLED UPON INSERTION" NO OTHER INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15328009 ↗MalfunctionMar 5, 2021Activation Problem; Activation Problem
IT WAS REPORTED I HAVE NOTICED A FEW OF THE PURPLE SCALPELS IN DIALYSIS KITS ARE NOT LOCKING CLOSED. ONE OF MY EMPLOYEES ACCIDENTALLY POKED THEMSELVES WITH ONE AND SHE STATED SHE HEARD IT CLICK BUT IT DID NOT ACTUALLY LOCK. NO OTHER INFORMATION WAS PROVIDED. ADDITIONAL INFORMATION RECEIVED (B)(6) 2021: THE DEVICE WAS USED ON A PATIENT AND THERE WAS NO REPORTED HARM.
Patient problems: Laceration(s)
MAUDE report 11425348 ↗MalfunctionNov 3, 2015Split
ON (B)(6) 2015 DOCTOR PLACED CATHETER IN LEFT IJ WITH ULTRASOUND AND GUIDEWIRE WAS OKAY. CATHETER REPORTEDLY THREADED OKAY. UPON REMOVING THE GUIDEWIRE, THE WIRE ALLEGEDLY SNAPPED AND SPLIT. THE WIRE HAD REPORTEDLY CUT THE DOCTOR'S GLOVE THROUGH TO HIS FINGER CUTTING THE SKIN. DOCTOR REPORTEDLY REMOVED THE CATHETER AND GUIDEWIRE AS ONE UNIT. SECOND CATHETER WAS PLACE W/O INCIDENT. DOCTOR FOLLOWED UP IN THE ER PER FACILITY PROTOCOL. FURTHER MEDICAL NEED UNKNOWN.
Patient problems: Injury
MAUDE report 5199444 ↗
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
- 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
- Power-Trialysis catheter 5605300Bard Access Systems, Inc. · CATHETER, HEMODIALYSIS, TRIPLE LUMEN, NON-IMPLANTED2 recalls0 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 · each recall links to the FDA recall notice
- 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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