Power-Trialysis catheterRecalls & reported problems across all models
Bard Access Systems, Inc. · 22 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
2 open recalls name at least one Power-Trialysis catheter model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 143
- Deaths reported
- 4
- Injuries reported
- 13
- Recalls
- 2
We found 22 models of Power-Trialysis catheter by Bard Access Systems, Inc. in the FDA's device registry (GUDID). Together they are named in 143 adverse event reports in the FDA's MAUDE database, received between Oct 27, 2015 and Sep 30, 2026 — classified as 4 deaths, 13 injuries, 126 malfunctions.
The most frequently reported specific device problem is “Material Deformation” (32 reports).
2 FDA recall records name at least one of these models by its device 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Power-Trialysis catheter recalls
FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.
- Aug 10, 2026Open, Classified
this is a downstream recall of class I recall RES 98777
Z-2984-2026 · Root cause: Material/Component Contamination · names 8 of these models · Recall details · FDA record ↗
- May 21, 2026Open, 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 · names 5 of these models · Recall details · FDA record ↗
Most reported Power-Trialysis catheter problems
Device problems
- Material Deformation32
- Material Frayed22
- Fluid/Blood Leak16
- Break13
- Component Incompatible8
- Defective Component6
- Device Dislodged or Dislocated5
- Difficult to Remove5
Patient problems
- No Clinical Signs, Symptoms or Conditions67
- No Known Impact Or Consequence To Patient29
- No Consequences Or Impact To Patient17
- Hemorrhage/Blood Loss/Bleeding7
- Foreign Body In Patient5
- No Patient Involvement5
- Air Embolism3
- Death2
Power-Trialysis catheter models
22 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Power-Trialysis catheter 5605150CATHETER, HEMODIALYSIS, TRIPLE LUMEN, NON-IMPLANTED2 recalls13 reports
- Power-Trialysis catheter 5605240CATHETER, HEMODIALYSIS, TRIPLE LUMEN, NON-IMPLANTED2 recalls8 reports
- Power-Trialysis catheter 5615200CATHETER, HEMODIALYSIS, TRIPLE LUMEN, NON-IMPLANTED2 recalls4 reports
- Power-Trialysis catheter 5615120CATHETER, HEMODIALYSIS, TRIPLE LUMEN, NON-IMPLANTED2 recalls0 reports
- Power-Trialysis catheter 5605300CATHETER, HEMODIALYSIS, TRIPLE LUMEN, NON-IMPLANTED2 recalls0 reports
- Power-Trialysis catheter 5605200CATHETER, HEMODIALYSIS, TRIPLE LUMEN, NON-IMPLANTED1 recall1 death15 reports
- Power-Trialysis catheter 5615150CATHETER, HEMODIALYSIS, TRIPLE LUMEN, NON-IMPLANTED1 recall2 deaths8 reports
- Power-Trialysis catheter 5615240CATHETER, HEMODIALYSIS, TRIPLE LUMEN, NON-IMPLANTED1 recall0 reports
- Power-Trialysis catheter 5603150CATHETER, HEMODIALYSIS, TRIPLE LUMEN, NON-IMPLANTED1 death17 reports
- Power-Trialysis catheter 5608200CATHETER, HEMODIALYSIS, TRIPLE LUMEN, NON-IMPLANTED16 reports
- Power-Trialysis catheter 5613150CATHETER, HEMODIALYSIS, TRIPLE LUMEN, NON-IMPLANTED13 reports
- Power-Trialysis catheter 5618150CATHETER, HEMODIALYSIS, TRIPLE LUMEN, NON-IMPLANTED10 reports
- Power-Trialysis catheter 5608240CATHETER, HEMODIALYSIS, TRIPLE LUMEN, NON-IMPLANTED8 reports
- Power-Trialysis catheter 5613240CATHETER, HEMODIALYSIS, TRIPLE LUMEN, NON-IMPLANTED6 reports
- Power-Trialysis catheter 5603200CATHETER, HEMODIALYSIS, TRIPLE LUMEN, NON-IMPLANTED5 reports
- Power-Trialysis catheter 5608150CATHETER, HEMODIALYSIS, TRIPLE LUMEN, NON-IMPLANTED5 reports
- Power-Trialysis catheter 5618200CATHETER, HEMODIALYSIS, TRIPLE LUMEN, NON-IMPLANTED4 reports
- Power-Trialysis catheter 5618240CATHETER, HEMODIALYSIS, TRIPLE LUMEN, NON-IMPLANTED4 reports
- Power-Trialysis catheter 5613200CATHETER, HEMODIALYSIS, TRIPLE LUMEN, NON-IMPLANTED3 reports
- Power-Trialysis catheter 5608300CATHETER, HEMODIALYSIS, TRIPLE LUMEN, NON-IMPLANTED2 reports
- Power-Trialysis catheter 5603300CATHETER, HEMODIALYSIS, TRIPLE LUMEN, NON-IMPLANTED1 report
- Power-Trialysis catheter 5613120CATHETER, HEMODIALYSIS, TRIPLE LUMEN, NON-IMPLANTED1 report
Recent Power-Trialysis catheter adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionSep 30, 2026Material Deformation
It was reported while inserting the dialysis catheter, the guidewire remained stuck inside the catheter. The entire catheter, including the guidewire, had to be removed. Upon removal, a visible kink was observed in the tip of the catheter, making it impossible to remove the guidewire. The procedure was completed using a 2nd kit. There was no patient harm.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50941803 ↗InjuryAug 25, 2026Material Frayed
It was reported via MedWatch that retained guidewire. Required intervention. No further details provided.
Patient problems: Foreign Body In Patient
MAUDE report 50434965 ↗MalfunctionAug 12, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50222200 ↗MalfunctionMay 28, 2026Product Quality Problem; Material Deformation
IT WAS REPORTED GUIDE WIRE WOULD NOT ADVANCE, RESISTANCE MET AT TIP OF CATHETER, ALL PORTS FLUSHED WITH STERILE WATER WITH NO ISSUES BUT IT SEEMED THE TIP OF THE CATHETER MAY HAVE BEEN FUSED. NO HARM TO THE PATIENT. ADDITIONALLY THE HOLDER WAS DEFECTIVE WHERE THE PLASTIC TUBING MEETS THE BLUE PLASTIC. GUIDEWIRE NEEDED TO BE REMOVED FROM THE HOLDER TO ADVANCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25319063 ↗MalfunctionFeb 25, 2026Material Deformation
IT WAS REPORTED ONCE INSERTED THE GUIDEWIRE IS COILING. WE OPENED THREE CATHETERS FOR ONE PATIENT, BUT THE SAME PROBLEM OF GUIDEWIRE COILING. NO HARM WAS FOR THE PATIENT OF HCP, IT'S JUST A DELAY OF TREATMENT. THIS REPORT ADDRESSES ALL THREE DEVICES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24446635 ↗MalfunctionFeb 25, 2026Material Deformation
IT WAS REPORTED THAT ONCE INSERTED, THE GUIDEWIRE IS COILING. WE OPENED THREE CATHETER FOR ONE PATIENT, BUT ALL HAD THE SAME PROBLEM OF GUIDEWIRE COILING. NO HARM WAS FOR THE PATIENT OR HCP, IT IS JUST A DELAY OF TREATMENT. THIS REPORT ADDRESSES ALL THREE DEVICES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24446634 ↗MalfunctionFeb 24, 2026Material Frayed
IT WAS REPORTED VIA MEDWATCH REPORT UNABLE TO ADVANCE CATHETER OVER WIRE WITH VISUALIZED PLASTIC DEFORMITY AT TIME ON INSPECTION. WHEN ATTEMPTED TO ADVANCE, WIRE BEGAN TO FRAY AND UNRAVEL. SECOND CATHETER KIT OBTAINED AND ADVANCED WITH SECONDARY PROVIDER AT BEDSIDE. NO HARM TO PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24430174 ↗MalfunctionFeb 18, 2026Fluid/Blood Leak
IT WAS REPORTED THIS OCCURRED WITH TWO DEVICES. THIS REPORT ADDRESSES BOTH DEVICES.
Patient problems: Insufficient Information
MAUDE report 24384164 ↗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 ↗MalfunctionDec 19, 2025Material Deformation; Material Deformation
IT WAS REPORTED DURING INSERTION, THE GUIDE WIRE BECAME TWISTED, AND CATHETER INSERTION WAS THEN IMPOSSIBLE. NO INTERVENTION NEEDED, NO PATIENT HARM. IT WAS REPORTED THIS OCCURRED WITH FOUR DEVICES. THIS REPORT ADDRESSES ALL FOUR DEVICES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23850251 ↗MalfunctionOct 30, 2025Material Deformation; Material Deformation
IT WAS REPORTED THAT THE CLIENT INDICATES THAT THE RED LUER EXTENSION IS ANGLED. THEY BELIEVE THAT THE CLAMP IN THE BLISTER WAS CLOSED AND CAUSED THE CATHETER TO BE PINCHED. THE CATHETER IS REMOVED AND REPLACED WITH AN EQUIVALENT ONE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23426684 ↗InjurySep 9, 2025Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED, PATIENT WAS PLACED WITH THE TRIALYSIS LINE. IN LESS THAN 24 HOURS, WHEN DREW BLOOD FROM THE LINE ABOUT AT LEAST 40CC OF AIR WAS DRAWN, CT SCAN ALSO INDICATES AIR AT THE LEFT SIDE OF THE NECK, PATIENT CURRENTLY UNDER OBSERVATION AND SUPPORTIVE MEASURES FOR AIR EMBOLISM. NO OTHER INFORMATION WAS PROVIDED.
Patient problems: Air Embolism
MAUDE report 23000491 ↗MalfunctionAug 21, 2025Product Quality Problem; Activation Problem; Product Quality Problem; Activation Problem
IT WAS REPORTED BY THE CUSTOMER THAT THE NEEDLE DRIVER FOR POWER TRIALYSIS SHORT TERM STRAIGHT DIALYSIS KIT IS NOT CLAMPING, RESULTING IN FREQUENT LOOSE NEEDLES IN THE FIELD AND A HIGH RISK OF NEEDLESTICK INJURY. NO HARM TO PATIENT. NO FURTHER INFORMATION PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22865001 ↗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 ↗MalfunctionJun 24, 2025Material Frayed; Material Frayed
IT WAS REPORTED THAT DURING A TRIALYSIS INSERTION THE GUIDEWIRE HAD SEPARATED. THE WIRE BEGAN TO SEPARATE WHEN THE VASCATH HAD ALREADY BEEN ADVANCED OVER THE WIRE, DURING REMOVAL THE PROVIDER NOTED RESISTANCE AND WHAT APPEAR TO BE SHEARING. HE STOPPED PULLING THE WIRE AND REMOVED VASCATH AND WIRE IN ITS ENTIRETY. THE PATIENT WAS NOT INJURED. NO REPORTED COMPLICATIONS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22323040 ↗
Other Bard Access Systems, Inc. products
- Port Access Needle122 models · 3,744 reports · 3 recalls
- Groshong NXT ClearVue Catheter8 models · 3,266 reports
- PowerPort ClearVUE27 models · 1,993 reports · 15 recalls
- Site~Rite 8 Ultrasound System11 models · 1,965 reports
- PowerPort M.R.I., ChronoFlex22 models · 1,642 reports · 1 recall
- PowerPICC Provena116 models · 1,337 reports · 2 recalls
- PowerPort M.R.I., Groshong10 models · 1,285 reports
- Navarre15 models · 1,228 reports
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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