Decathlon DF Long-Term Hemodialysis CatheterRecalls & reported problems across all models
Bard Access Systems, Inc. · 8 models in the FDA device registry
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 29
- Deaths reported
- 0
- Injuries reported
- 3
- Recalls
- 0
We found 8 models of Decathlon DF Long-Term Hemodialysis Catheter by Bard Access Systems, Inc. in the FDA's device registry (GUDID). Together they are named in 29 adverse event reports in the FDA's MAUDE database, received between Apr 19, 2017 and Oct 22, 2025 — classified as 3 injuries, 26 malfunctions.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (9 reports).
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
Most reported Decathlon DF Long-Term Hemodialysis Catheter problems
Device problems
- Detachment of Device or Device Component9
- Fluid/Blood Leak8
- Fracture8
- Device Dislodged or Dislocated3
- Break2
- Deformation Due to Compressive Stress2
- Failure to Advance2
- Material Separation2
Patient problems
- No Clinical Signs, Symptoms or Conditions16
- No Consequences Or Impact To Patient7
- Injury2
- No Known Impact Or Consequence To Patient2
- No Patient Involvement1
- Thrombosis/Thrombus1
- Unspecified Infection1
Decathlon DF Long-Term Hemodialysis Catheter models
8 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Decathlon DF Long-Term Hemodialysis Catheter DF23SH28KCatheter, hemodialysis, implanted11 reports
- Decathlon DF Long-Term Hemodialysis Catheter DF19SH24KCatheter, hemodialysis, implanted7 reports
- Decathlon DF Long-Term Hemodialysis Catheter DF27IT32KCatheter, hemodialysis, implanted4 reports
- Decathlon DF Long-Term Hemodialysis Catheter DF19IT24KCatheter, hemodialysis, implanted2 reports
- Decathlon DF Long-Term Hemodialysis Catheter DF23IT28KCatheter, hemodialysis, implanted2 reports
- Decathlon DF Long-Term Hemodialysis Catheter DF27SH32KCatheter, hemodialysis, implanted1 report
- Decathlon DF Long-Term Hemodialysis Catheter DF31IT36KCatheter, hemodialysis, implanted1 report
- Decathlon DF Long-Term Hemodialysis Catheter DF35SH40KCatheter, hemodialysis, implanted1 report
Recent Decathlon DF Long-Term Hemodialysis Catheter adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionOct 22, 2025Fracture; Material Separation; Fracture; Material Separation
A PATIENT UNDERWENT A PLACEMENT PROCEDURE USING DECATHLON HEMODIALYSIS CATHETER. DURING THE PLACEMENT PROCEDURE, THE WHITE SHEATH ON THE TUNNELER ALLEGEDLY FOUND CRACKED AND CAME OFF THE METAL TUNNELER. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23355890 ↗InjuryOct 21, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THROUGH LITIGATION PROCESS THAT SOMETIME LATER PORT PLACEMENT PROCEDURE, THE PATIENT DEVELOPED WITH UNSPECIFIED INFECTION AND THROMBOSIS. THE CURRENT STATUS OF THE PATIENT WAS UNKNOWN.
Patient problems: Thrombosis/Thrombus; Unspecified Infection
MAUDE report 23345177 ↗MalfunctionNov 14, 2024Failure to Advance; Deformation Due to Compressive Stress; Failure to Advance; Deformation Due to Compressive Stress
IT WAS REPORTED THAT DURING A PREPARATION OF DIALYSIS PLACEMENT PROCEDURE IN THE RIGHT INTERNAL JUGULAR VEIN FOR HEMODIALYSIS ACCESS, THE CATHETER WAS ALLEGEDLY KINKED. IT WAS FURTHER REPORTED THAT THE DEVICE ALLEGEDLY FAILED TO ADVANCE OVER THE WIRE. THE PROCEDURE WAS COMPLETED USING SAME DEVICE. THERE WAS NO PATIENT CONTACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20681428 ↗MalfunctionOct 25, 2023Contamination /Decontamination Problem; Contamination /Decontamination Problem
IT WAS REPORTED THAT PRIOR TO A DIALYSIS CATHETER PLACEMENT PROCEDURE, THE CATHETER AND PEEL AWAY SHEATH ALLEGEDLY HAD FOREIGN COATING. THE PROCEDURE WAS COMPLETED BY USING ANOTHER DEVICE. THERE WAS NO PATIENT CONTACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18005407 ↗MalfunctionJun 13, 2023Fracture; Material Separation; Detachment of Device or Device Component; Fracture; Material Separation; Detachment of Device or Device Component
IT WAS REPORTED THAT DURING A DIALYSIS CATHETER PLACEMENT PROCEDURE, THE CATHETER ALLEGEDLY BROKEN AWAY FROM TUNNELER. IT WAS FURTHER REPORTED THAT BROKEN CATHETER WAS ALLEGEDLY SEPARATED AND WOULD NOT STAY ON. THE PROCEDURE WAS COMPLETED BY USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17115579 ↗MalfunctionJun 6, 2023Fracture; Fracture
IT WAS REPORTED THAT DURING THE PREPARATION OF A DIALYSIS CATHETER PLACEMENT PROCEDURE, A SPLIT WAS ALLEGEDLY NOTICED IN THE TIP OF THE CATHETER UPON OPENING THE PACKAGE. THE PROCEDURE WAS COMPLETED BY USING ANOTHER DEVICE. THERE WAS NO PATIENT CONTACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17069062 ↗MalfunctionOct 24, 2022Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT DURING A DIALYSIS CATHETER PLACEMENT PROCEDURE, CATHETER ALLEGEDLY DETACHED FROM THE TUNNELER. THE PROCEDURE WAS COMPLETED USING THE SAME DEVICE. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15657458 ↗MalfunctionOct 24, 2022Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT DURING A DIALYSIS CATHETER PLACEMENT PROCEDURE, THE CATHETER ALLEGEDLY DETACHED FROM THE TUNNELER. THE PROCEDURE WAS COMPLETED USING THE SAME DEVICE. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15657423 ↗MalfunctionSep 16, 2022Fracture; Failure to Advance; Fracture; Failure to Advance
IT WAS REPORTED THAT DURING A DIALYSIS CATHETER PLACEMENT PROCEDURE, THE DEVICE ALLEGEDLY FAILED TO ADVANCE. IT WAS FURTHER REPORTED THAT THE PORTION OF THE DEVICE WAS BROKEN AND PINCHING ON THE CHEST OF THE PATIENT. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15439635 ↗MalfunctionAug 23, 2022Restricted Flow rate; Restricted Flow rate
IT WAS REPORTED THAT DURING A DIALYSIS CATHETER PLACEMENT PROCEDURE, THE DEVICE ALLEGEDLY HAD A LOW FLOW RATE. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15273653 ↗MalfunctionJul 26, 2021Deformation Due to Compressive Stress; Deformation Due to Compressive Stress
IT WAS REPORTED THAT POST CATHETER PLACEMENT, THE CATHETER ALLEGEDLY KINKED. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12223298 ↗MalfunctionApr 7, 2021Fracture; Detachment of Device or Device Component; Fracture; Detachment of Device or Device Component
IT WAS REPORTED THAT DURING CATHETER PLACEMENT PROCEDURE, THE CATHETER SHEATH ALLEGEDLY BROKEN AND RESTED ON THE ADJACENT SHEATH STOP. IT WAS FURTHER REPORTED THAT THE TUNNELER ALLEGEDLY DETACHED FORM THE CATHETER. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11626100 ↗MalfunctionApr 7, 2021Fracture; Detachment of Device or Device Component; Fracture; Detachment of Device or Device Component
IT WAS REPORTED THAT DURING CATHETER PLACEMENT PROCEDURE, THE CATHETER SHEATH ALLEGEDLY BROKEN AND RESTED ON THE ADJACENT SHEATH STOP. IT WAS FURTHER REPORTED THAT THE TUNNELER ALLEGEDLY DETACHED FORM THE CATHETER. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11626005 ↗MalfunctionApr 5, 2021Fracture; Detachment of Device or Device Component; Fracture; Detachment of Device or Device Component
IT WAS REPORTED THAT DURING CATHETER PLACEMENT PROCEDURE, THE CATHETER SHEATH ALLEGEDLY BROKEN AND RESTED ON THE ADJACENT SHEATH STOP. IT WAS FURTHER REPORTED THAT THE TUNNELER ALLEGEDLY DETACHED FROM THE CATHETER. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11613056 ↗MalfunctionMar 8, 2021Fracture; Detachment of Device or Device Component; Fracture; Detachment of Device or Device Component
IT WAS REPORTED THAT DURING CATHETER PLACEMENT PROCEDURE, THE CATHETER SHEATH ALLEGEDLY BROKEN AND RESTED ON THE ADJACENT SHEATH STOP. IT WAS FURTHER REPORTED THAT THE TUNNELER ALLEGEDLY DETACHED FROM THE CATHETER. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11433467 ↗
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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