Power-Trialysis Slim-Cath catheter 5855240Recalls & reported problems
Bard Access Systems, Inc. · 12Fr Trialysis ST 24cm Tray · Class 2
All models of Power-Trialysis Slim-Cath catheter (11)
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
- 0
- Recalls naming it
- 2
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00801741107177), received between Jun 29, 2022 and Feb 12, 2025 — classified as 4 malfunctions.
The most frequently reported specific device problem is “Defective Component” (3 reports).
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-2661-2026 · Root cause: Nonconforming Material/Component · Recall details · FDA record ↗
Most reported problems
Device problems
- Defective Component3
- Fluid/Blood Leak1
- Material Frayed1
Patient problems
- No Clinical Signs, Symptoms or Conditions3
- Burning Sensation1
- Erythema1
- Skin Inflammation/ Irritation1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 12, 2025Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED (B)(6) 2024 - INSERTION SITE RED, SLIGHT CLEAR DISCHARGE. (B)(6) 2024 - LEAKED CHEMO DRUG, NO SWELLING, REDNESS. SMALL HOLE AT 4 CM MARK. AFTER LINE REMOVAL ANOTHER FRACTURED AT 7 CM MARK NOTED CANNULA WAS REINSERTED FOR CHEMO. NO OTHER INFORMATION WAS PROVIDED.
Patient problems: Burning Sensation; Erythema; Skin Inflammation/ Irritation
MAUDE report 21363682 ↗MalfunctionSep 6, 2024Defective Component; Defective Component
IT WAS REPORTED BY THE CUSTOMER THAT PURPLE LUMEN CLAMP BROKEN. NO PATIENT IMPACT OR INJURY REPORTED. NO OTHER INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20161990 ↗MalfunctionAug 23, 2024Defective Component; Defective Component
IT WAS REPORTED ON 7/09/2024, WE HAD A TRIPLE LUMEN BARD CENTRAL LINE-PURPLE LUMEN CLAMP BROKEN BARD LOT # REHS3822 PLACED ON (B)(6) 2023. THE DEFECTIVE BARD CATHETER IS STILL ON THE PATIENT, HE IS NOT DONE WITH TREATMENT. THE BROKEN CLAMP WAS A SAFETY ISSUE ONLY AND HAS NOT INTERRUPTED THE PATIENT'S TREATMENT. WE HAVE ATTACHED A REPLACEMENT CLAMP. NO OTHER INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20053754 ↗MalfunctionJun 29, 2022Material Frayed; Defective Component; Material Frayed; Defective Component
IT WAS REPORTED "DURING PLACEMENT OF CVC, IT WAS FOUND THAT THE J WIRE WAS PARTIALLY UNRAVELED AT ABOUT 5CM FROM THE J. NO METAL WAS EVER IN CONTACT WITH THE J WIRE. POTENTIAL EQUIPMENT MALFUNCTION VERSUS SHEARING OF THE J WIRE AT THE TIP OF THE MICROINTRODUCER CATHETER." PATIENT HARM: THE PATIENT SUFFERED EMOTIONAL DISTRESS OR INCONVENIENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14860536 ↗
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 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
- 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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