HemoSplit Long-Term Hemodialysis Catheter 5733274Recalls & reported problems
Bard Access Systems, Inc. · HEMOSPLIT HEMODIALYSIS CATH, ST, AIRGUARD, TAPERED CUFF, 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
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00801741013034), received between Aug 4, 2020 and Aug 4, 2020 — classified as 1 malfunction.
The most frequently reported specific device problem is “Material Protrusion/Extrusion” (1 report).
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.
Most reported problems
Device problems
- Material Protrusion/Extrusion1
- Stretched1
Patient problems
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 4, 2020Stretched; Material Protrusion/Extrusion; Stretched; Material Protrusion/Extrusion
IT WAS REPORTED THAT POST CATHETER PLACEMENT IN RIGHT INTERNAL JUGULAR VEIN, THE TUBE OF THE CATHETER ALLEGEDLY BULGED. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10361452 ↗
Other Catheter, hemodialysis, implanted devices
- Palindrome 8888145014Mozarc Medical US LLC · Catheter, hemodialysis, implanted1 recall312 reports
- Palindrome 8888145015Mozarc Medical US LLC · Catheter, hemodialysis, implanted2 recalls1 death219 reports
- 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.
How reports and recalls are matched · Editorial policy · Report an error on this page