HemoSplit Long-Term Hemodialysis Catheter 5734420Recalls & reported problems
Bard Access Systems, Inc. · HEMOSPLIT HEMODIALYSIS CATH, ST, AIRGUARD, 14.5 FR. 42cm · 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
- 4
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00801741013157), received between May 8, 2019 and Jul 17, 2025 — classified as 4 malfunctions.
The most frequently reported specific device problem is “Deformation Due to Compressive Stress” (2 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 Stress2
- Component Missing1
- Fracture1
- Product Quality Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions3
- No Patient Involvement1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 17, 2025Deformation Due to Compressive Stress; Deformation Due to Compressive Stress
A PATIENT UNDERWENT A DIALYSIS CATHETER PLACEMENT PROCEDURE USING HEMOSPLIT CATHETER. ON (B)(6) 2025, THE CUSTOMER WAS ALLEGEDLY CHANGING THE CLAMPING LOCATION OF THE CATHETERS TO PREVENT THEM FROM BENDING AND BREAKING. REPORTEDLY, THE CATHETER SHOWED MEMORY AND FOLDS IN THE SILICONE WHERE THE CLAMPING IS PERFORMED. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22528355 ↗MalfunctionJun 6, 2025Product Quality Problem; Deformation Due to Compressive Stress; Product Quality Problem; Deformation Due to Compressive Stress
ON (B)(6) 2025, A PATIENT UNDERWENT A DIALYSIS CATHETER PLACEMENT PROCEDURE USING THE HEMOSPLIT CATHETER AND DURING THE PROCEDURE THERE WAS A BEND IN THE SHORT AND LONG TIPS OF THE CATHETER, AS THERE WAS NO GUIDE INSIDE THE CATHETER, MAKING IT EXTREMELY DIFFICULT TO POSITION CORRECTLY WITHOUT FLOW REVERSAL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22158395 ↗MalfunctionAug 10, 2021Fracture; Fracture
IT WAS REPORTED THAT DURING A PROCEDURE, THE CATHETER ALLEGEDLY BROKEN. THE PROCEDURE WAS COMPLETED BY USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12299147 ↗MalfunctionMay 8, 2019Component Missing; Component Missing
IT WAS REPORTED THAT UPON OPENING THE PACKAGE THE DEVICE WAS MISSING. THERE WAS NO REPORTED PATIENT CONTACT.
Patient problems: No Patient Involvement
MAUDE report 8592897 ↗
Other Catheter, hemodialysis, implanted devices
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- HemoStar Long-Term Hemodialysis Catheter 5833690Bard Access Systems, Inc. · Catheter, hemodialysis, implanted2 deaths290 reports
- Palindrome 8888119369PMozarc Medical US LLC · Catheter, hemodialysis, implanted3 recalls1 death14 reports
- HemoStar Long-Term Hemodialysis Catheter 5833730Bard Access Systems, Inc. · Catheter, hemodialysis, implanted1 death141 reports
- GlidePath Long-Term Hemodialysis Catheter with Preloaded Stylet 5393230Bard Access Systems, Inc. · Catheter, hemodialysis, implanted5 deaths138 reports
- Palindrome 8888123404PMozarc Medical US LLC · Catheter, hemodialysis, implanted2 recalls1 death17 reports
- Palindrome 8888119364PMozarc Medical US LLC · Catheter, hemodialysis, implanted2 recalls1 death17 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
- 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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