HemoSplit Long-Term Hemodialysis Catheter 5743270Recalls & reported problems
Bard Access Systems, Inc. · HEMOSPLIT HEMODIALYSIS CATH, ST, w/MI/GUIDEWIRE, AIRGUARD, 14.5 FR., 27cm · 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 00801741013218), received between Jul 23, 2019 and Nov 4, 2024 — classified as 4 malfunctions.
The most frequently reported specific device problem is “Packaging Problem” (3 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
- Packaging Problem3
- Unsealed Device Packaging2
- Ambient Temperature Problem1
- Component Missing1
- Material Deformation1
- Melted1
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.
MalfunctionNov 4, 2024Packaging Problem; Packaging Problem
IT WAS REPORTED THAT DURING THE PREPARATION OF A DIALYSIS CATHETER PLACEMENT PROCEDURE, THE OUTER PACKAGING OF THE CATHETER WAS ALLEGEDLY DAMAGED. THERE WAS NO PATIENT CONTACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20597160 ↗MalfunctionJul 10, 2023Unsealed Device Packaging; Material Deformation; Packaging Problem; Unsealed Device Packaging; Material Deformation; Packaging Problem
IT WAS REPORTED THAT PRIOR TO A DIALYSIS CATHETER PLACEMENT PROCEDURE, THE PACKAGE WAS ALLEGEDLY DEFORMED AND NOT SEALED TIGHTLY. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO PATIENT CONTACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17285607 ↗MalfunctionJul 8, 2022Melted; Unsealed Device Packaging; Ambient Temperature Problem; Packaging Problem; Melted; Unsealed Device Packaging; Ambient Temperature Problem; Packaging Problem
IT WAS REPORTED THAT DURING PREPARATION OF A DIALYSIS CATHETER PLACEMENT PROCEDURE, THE PACKAGE WAS ALLEGEDLY DEFORMED AND UNSEALED. THERE WAS NO PATIENT CONTACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14953258 ↗MalfunctionJul 23, 2019Component Missing; Component Missing
IT WAS REPORTED THAT PRIOR TO DIALYSIS CATHETER PLACEMENT THE GUIDEWIRE WAS ALLEGEDLY ABSENT FROM THE KIT. IT WAS FURTHER REPORTED THAT THE PROCEDURE WAS COMPLETED USING ANOTHER MANUFACTURING KIT. THERE WAS NO REPORTED PATIENT CONTACT.
Patient problems: No Patient Involvement
MAUDE report 8817340 ↗
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- 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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