Power-Trialysis catheter 5613120Recalls & reported problems
Bard Access Systems, Inc. · 13Fr Trialysis PC 12.5cm Kit · Class 2
All models of Power-Trialysis catheter (22)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00801741041938), received between Feb 26, 2020 and Feb 26, 2020 — classified as 1 injury.
The most frequently reported specific device problem is “Material Frayed” (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.
Most reported problems
Device problems
- Material Frayed1
Patient problems
- Foreign Body In Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryFeb 26, 2020Material Frayed; Material Frayed
IT WAS REPORTED VIA RECEIVED MEDWATCH THAT THE "DOCTOR WAS PLACING BD CATH ON PATIENT. UPON REMOVAL OF THE GUIDE WIRE THE INNER PART OF WIRE WAS REMOVED WHILE THE OUTER COIL PEELED AWAY APPARENTLY BROKE OFF INSIDE THE PATIENT. THIS WAS VISUALIZED ON POST LINE CHEST X-RAY. THE ORIGINAL CATHETER INITIALLY GAVE BLOOD RETURN BUT AFTER PLACEMENT THERE WAS NO BLOOD RETURN. THIS CATHETER WAS REMOVED AND ANOTHER WAS INSERTED WITHOUT ISSUE. REPEAT X-RAY STILL SHOWED WIRE SO A CT SCAN OF CHEST WAS DONE AND PATIENT WAS SCHEDULED TO GO TO THE CATH LAB FOR REMOVAL OF WIRE"
Patient problems: Foreign Body In Patient
MAUDE report 9756957 ↗
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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