GlidePath Long-Term Hemodialysis Catheter with Preloaded Stylet 5393420Recalls & reported problems
Bard Access Systems, Inc. · GLIDEPATH HEMODIALYSIS CATH, ST, DL, 14.5 FR. 42cm · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 9
- Deaths reported
- 0
- Injuries reported
- 5
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00801741012228), received between Sep 20, 2024 and Sep 3, 2025 — classified as 5 injuries, 4 malfunctions.
The most frequently reported specific device problem is “Fracture” (8 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
- Fracture8
- Material Separation4
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Unspecified Infection5
- Bacterial Infection4
- No Clinical Signs, Symptoms or Conditions4
Recent adverse event reports
The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.
InjurySep 3, 2025Fracture; Material Separation; Fracture; Material Separation
A PATIENT UNDERWENT A DIALYSIS CATHETER PLACEMENT PROCEDURE USING GLIDEPATH. ON (B)(6) 2024, POST PLACEMENT PROCEDURE, IT WAS REPORTED THAT THE CLAMPS ALLEGEDLY BROKE OFF. REPORTEDLY PATIENT EXPERIENCED INFECTION. THE CURRENT STATUS OF THE PATIENT WAS UNKNOWN.
Patient problems: Bacterial Infection; Unspecified Infection
MAUDE report 22949522 ↗InjurySep 3, 2025Fracture; Material Separation; Fracture; Material Separation
A PATIENT UNDERWENT A DIALYSIS CATHETER PLACEMENT PROCEDURE USING GLIDEPATH. ON (B)(6) 2024, POST PLACEMENT PROCEDURE, IT WAS REPORTED THAT THE CLAMPS ALLEGEDLY BROKE OFF. REPORTEDLY PATIENT EXPERIENCED INFECTION. THE CURRENT STATUS OF THE PATIENT WAS UNKNOWN.
Patient problems: Bacterial Infection; Unspecified Infection
MAUDE report 22949521 ↗InjurySep 3, 2025Fracture; Material Separation; Fracture; Material Separation
A PATIENT UNDERWENT A DIALYSIS CATHETER PLACEMENT PROCEDURE USING GLIDEPATH. ON (B)(6) 2024, POST PLACEMENT PROCEDURE, IT WAS REPORTED THAT THE CLAMPS ALLEGEDLY BROKE OFF. REPORTEDLY PATIENT EXPERIENCED INFECTION. THE CURRENT STATUS OF THE PATIENT WAS UNKNOWN.
Patient problems: Bacterial Infection; Unspecified Infection
MAUDE report 22949520 ↗InjurySep 3, 2025Fracture; Material Separation; Fracture; Material Separation
A PATIENT UNDERWENT A DIALYSIS CATHETER PLACEMENT PROCEDURE USING GLIDEPATH. ON (B)(6) 2024, POST PLACEMENT PROCEDURE, IT WAS REPORTED THAT THE CLAMPS ALLEGEDLY BROKE OFF. REPORTEDLY PATIENT EXPERIENCED INFECTION. THE CURRENT STATUS OF THE PATIENT WAS UNKNOWN.
Patient problems: Bacterial Infection; Unspecified Infection
MAUDE report 22949499 ↗InjuryJul 28, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED IN ARTICLE IN THE CASE REPORT "RADIOLOGY CASE REPORTS" TITLED, "SUCCESSFUL HEMODIALYSIS CATHETER PLACEMENT INTO A STENOSED FEMORAL VEIN USING BALLOON DILATION FOR CENTRAL VENOUS ACCESS" THAT SOMETIME LATER POST CENTRAL VENOUS CATHETER PLACEMENT THROUGH RIGHT FEMORAL VEIN FOR HEMODIALYSIS FOR END-STAGE RENAL FAILURE, PATIENT DEVELOPED WITH UNSPECIFIED INFECTION. IT WAS FURTHER REPORTED THAT THE INFECTED CATHETER WAS REMOVED. THE CURRENT STATUS OF THE PATIENT WAS UNKNOWN.
Patient problems: Unspecified Infection
MAUDE report 22639950 ↗MalfunctionSep 21, 2024Fracture; Fracture
IT WAS REPORTED THAT SOMETIME POST A DIALYSIS CATHETER PLACEMENT, THE CLIP THAT HOLD THE LINE TOGETHER ALLEGEDLY BROKE. REPORTEDLY, THE CATHETER WAS REPLACED. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20275019 ↗MalfunctionSep 20, 2024Fracture; Fracture
IT WAS REPORTED THAT SOMETIME POST A DIALYSIS CATHETER PLACEMENT, THE CLAMPS WERE ALLEGEDLY BREAKING ON THE CATHETERS. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20265215 ↗MalfunctionSep 20, 2024Fracture; Fracture
IT WAS REPORTED THAT SOMETIMES POST A DIALYSIS CATHETER PLACEMENT, THE CLAMP WAS ALLEGEDLY FOUND TO BE BROKEN ON THE CATHETER. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20265211 ↗MalfunctionSep 20, 2024Fracture; Fracture
IT WAS REPORTED THAT SOMETIME POST A DIALYSIS CATHETER PLACEMENT, THE CLAMP ALLEGEDLY BROKE ON THE CATHETER. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20265210 ↗
Other Catheter, hemodialysis, implanted devices
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- 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.
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