HemoSplit Long-Term Hemodialysis Catheter 5735150Recalls & reported problems
Bard Access Systems, Inc. · HEMOSPLIT HEMODIALYSIS CATH, ALPHACURVE, AIRGUARD, 14.5 FR. 19cm · Class 2 · Implant
All models of HemoSplit Long-Term Hemodialysis Catheter (18)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 9
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00801741013171), received between Oct 17, 2017 and Aug 8, 2025 — classified as 9 malfunctions.
The most frequently reported specific device problem is “Deformation Due to Compressive Stress” (6 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, 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
Most reported problems
Device problems
- Deformation Due to Compressive Stress6
- Material Deformation3
- Material Opacification3
- Melted3
- Failure to Advance2
- Fracture2
- Device Operates Differently Than Expected1
- Material Discolored1
Patient problems
- No Clinical Signs, Symptoms or Conditions8
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 8, 2025Deformation Due to Compressive Stress; Deformation Due to Compressive Stress
ON (B)(60 2025, DURING A DIALYSIS CATHETER PLACEMENT PROCEDURE, THE EXTENSION LEGS WERE ALLEGEDLY FOUND KINKED. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22747154 ↗MalfunctionAug 8, 2025Deformation Due to Compressive Stress; Deformation Due to Compressive Stress
ON (B)(6) 2025, DURING A DIALYSIS CATHETER PLACEMENT PROCEDURE, THE EXTENSION LEGS WERE ALLEGEDLY FOUND KINKED. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22746979 ↗MalfunctionAug 8, 2025Deformation Due to Compressive Stress; Deformation Due to Compressive Stress
ON (B)(6) 2025, DURING A DIALYSIS CATHETER PLACEMENT PROCEDURE, THE EXTENSION LEGS WERE ALLEGEDLY FOUND KINKED. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22746976 ↗MalfunctionMar 7, 2025Fracture; Failure to Advance; Physical Resistance/Sticking; Fracture; Failure to Advance; Physical Resistance/Sticking
IT WAS REPORTED THAT DURING TUNNELING PROCEDURE, DIFFICULTY PLACING THE SLEEVE OVER THE CATHETER AND BY PUSHING HARD ON THE SLEEVE AFTER ATTACHED THE CATHETER. REPORTEDLY, THERE WAS BREAKAGE OF THE TUNNELLER SLEEVE DURING THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21545696 ↗MalfunctionAug 6, 2024Melted; Material Opacification; Deformation Due to Compressive Stress; Material Deformation; Melted; Material Opacification; Deformation Due to Compressive Stress; Material Deformation
IT WAS REPORTED THAT SOMETIME POST A DIALYSIS CATHETER PLACEMENT, THE CATHETER INLET AND OUTLET LINE WAS ALLEGEDLY MOLDED AND MELTED. IT WAS FURTHER REPORTED THAT THE CATHETER ALLEGEDLY BECAME OFF WHITE COLOR. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19917293 ↗MalfunctionAug 6, 2024Melted; Material Opacification; Deformation Due to Compressive Stress; Material Deformation; Melted; Material Opacification; Deformation Due to Compressive Stress; Material Deformation
IT WAS REPORTED THAT SOMETIME POST A DIALYSIS CATHETER PLACEMENT, THE CATHETER INLET AND OUTLET LINE WAS ALLEGEDLY MOLDED AND MELTED. IT WAS FURTHER REPORTED THAT THE CATHETER ALLEGEDLY BECAME OFF WHITE COLOR. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19917206 ↗MalfunctionAug 5, 2024Material Discolored; Melted; Material Opacification; Deformation Due to Compressive Stress; Material Deformation; Material Discolored; Melted; Material Opacification; Deformation Due to Compressive Stress; Material Deformation
IT WAS REPORTED THAT SOMETIME POST A DIALYSIS CATHETER PLACEMENT, THE CATHETER INLET AND OUTLET LINE WAS ALLEGEDLY MOLDED AND MELTED. IT WAS FURTHER REPORTED THAT THE CATHETER ALLEGEDLY BECAME OFF WHITE COLOR. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19907531 ↗MalfunctionDec 9, 2021Fracture; Failure to Advance; Fracture; Failure to Advance
IT WAS REPORTED THAT DURING A DIALYSIS CATHETER PLACEMENT PROCEDURE IN THE RIGHT INTERNAL JUGULAR VEIN TO TREAT ESRD FOR DIALYSIS AND WHILE PULLING THE CATHETER TOWARDS THE INTERNAL JUGULAR VEIN, THE CATHETER TIP WAS ALLEGEDLY BROKEN AND WAS REPORTED TO HAVE FAILED TO ADVANCE. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12965904 ↗MalfunctionOct 17, 2017Device Operates Differently Than Expected; No Flow
IT WAS REPORTED THAT SOON AFTER THE PROCEDURE WAS COMPLETED, THE TUBE STARTED TO PROVIDE NO FLOW COMING DURING DIALYSIS. IT WAS STATED THE VALVE WAS NOT WORKING AND WAS NOT BLOCKING THE BLOOD. UPON FURTHER EXAMINATION THE FACILITY CONCLUDED THAT "THE TUBE IN ITSELF IS FAULTY AND NEEDS A REPLACEMENT".
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6955982 ↗
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- Palindrome 8888123404PMozarc Medical US LLC · Catheter, hemodialysis, implanted2 recalls1 death17 reports
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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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