Power-Trialysis Alphacurve catheterRecalls & reported problems across all models
Bard Access Systems, Inc. · 6 models in the FDA device registry
Data updated Oct 18, 2026 from official FDA records · Editorial policy
2 open recalls name at least one Power-Trialysis Alphacurve catheter model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 6
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls
- 2
We found 6 models of Power-Trialysis Alphacurve catheter by Bard Access Systems, Inc. in the FDA's device registry (GUDID). Together they are named in 6 adverse event reports in the FDA's MAUDE database, received between Jun 14, 2018 and Apr 1, 2022 — classified as 6 malfunctions.
The most frequently reported specific device problem is “Nonstandard Device” (5 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
Power-Trialysis Alphacurve 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, 2026Class IOpen, Classified
this is a downstream recall of class I recall RES 98777
Z-2984-2026 · Root cause: Material/Component Contamination · names 4 of these models · 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 Power-Trialysis Alphacurve catheter problems
Device problems
- Nonstandard Device5
- Break1
Patient problems
- No Patient Involvement3
- No Clinical Signs, Symptoms or Conditions2
- No Known Impact Or Consequence To Patient1
Power-Trialysis Alphacurve catheter models
6 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Power-Trialysis Alphacurve catheter 5655120CATHETER, HEMODIALYSIS, TRIPLE LUMEN, NON-IMPLANTED2 recalls0 reports
- Power-Trialysis Alphacurve catheter 5655200CATHETER, HEMODIALYSIS, TRIPLE LUMEN, NON-IMPLANTED1 recall2 reports
- Power-Trialysis Alphacurve catheter 5655150CATHETER, HEMODIALYSIS, TRIPLE LUMEN, NON-IMPLANTED1 recall0 reports
- Power-Trialysis Alphacurve catheter 5655240CATHETER, HEMODIALYSIS, TRIPLE LUMEN, NON-IMPLANTED1 recall0 reports
- Power-Trialysis Alphacurve catheter 5653150CATHETER, HEMODIALYSIS, TRIPLE LUMEN, NON-IMPLANTED3 reports
- Power-Trialysis Alphacurve catheter 5653200CATHETER, HEMODIALYSIS, TRIPLE LUMEN, NON-IMPLANTED1 report
Recent Power-Trialysis Alphacurve catheter adverse event reports
The 6 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionApr 1, 2022Nonstandard Device; Nonstandard Device
IT WAS REPORTED THE CATHETER WAS NOT THE SIZE THAT THE PACKAGE STATED. THE CATHETER WAS 24CM AND THE PACKAGING STATES 20CM CATHETER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13978080 ↗MalfunctionMar 25, 2022Nonstandard Device; Nonstandard Device
IT WAS REPORTED BY HEALTHCARE PROFESSIONAL "WE HAD A COMPLAINT FROM A PHYSICIAN ABOUT THE SIZE OF THE CATHETER NOT BEING WHAT THE PACKAGE SAID IT WAS. IT WAS BROUGHT TO MY ATTENTION YESTERDAY THAT THE CATHETER IN THIS KIT WAS A 24CM CATHETER AND THE PACKAGING STATES THE CATHETER IS 20CM. HE PLACED THE LINE IN FACILITY. THIS PRESENTS A CHALLENGE IN PLACING THE LINE AND IN SECURING THE LINE."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13908781 ↗MalfunctionSep 20, 2019Nonstandard Device; Nonstandard Device
IT WAS REPORTED THAT THERE WAS A 12.5CM TRIALYSIS INSIDE OF A 15CM KIT PACKAGING. FACILITY STATED THIS OCCURRED WITH THREE KITS. THIS REPORT ADDRESSES THE FIRST KIT.
Patient problems: No Patient Involvement
MAUDE report 9098120 ↗MalfunctionSep 20, 2019Nonstandard Device; Nonstandard Device
IT WAS REPORTED THAT THERE WAS A 12.5CM TRIALYSIS INSIDE OF A 15CM KIT PACKAGING. FACILITY STATED THIS OCCURRED WITH THREE KITS. THIS REPORT ADDRESSES THE SECOND KIT.
Patient problems: No Patient Involvement
MAUDE report 9098118 ↗MalfunctionSep 20, 2019Nonstandard Device; Nonstandard Device
IT WAS REPORTED THAT THERE WAS A 12.5CM TRIALYSIS INSIDE OF A 15CM KIT PACKAGING. FACILITY STATED THIS OCCURRED WITH THREE KITS. THIS REPORT ADDRESSES THE THIRD KIT.
Patient problems: No Patient Involvement
MAUDE report 9098117 ↗MalfunctionJun 14, 2018Break
IT WAS REPORTED THAT THE CLAMP ON THE BLUE LUMEN OF A TRIALYSIS CATHETER BROKE. THIS CATHETER WAS PLACED AND WAS THEN REPLACED OVER THE WIRE ONCE THE CLAMP BROKE. IT WAS STATED IT WAS NOT USED FOR DIALYSIS AND IT BROKE UPON INITIAL PLACEMENT. PATIENT WAS NOT HARMED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7603962 ↗
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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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