GlidePath Long-Term Hemodialysis Catheter with Preloaded Stylet 5393270Recalls & reported problems

Summary

The FDA's MAUDE database contains 29 adverse event reports that list this exact device (DI 00801741012198), received between Jul 3, 2018 and Feb 3, 2026 — classified as 4 injuries, 25 malfunctions.

The most frequently reported specific device problem is “Deformation Due to Compressive Stress” (7 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.

Most reported problems

Recent adverse event reports

The 25 most recent of 29 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 3, 2026Fluid/Blood Leak; Fracture; Material Puncture/Hole; Deformation Due to Compressive Stress; Material Deformation

  ON (B)(6) 2025, A PATIENT UNDERWENT A DIALYSIS CATHETER PLACEMENT PROCEDURE USING GLIDEPATH HEMODIALYSIS CATHETER. DURING THE PROCEDURE, IT WAS NOTED THAT THERE WAS A HOLE IN THE VENOUS/BLUE LIMB AND FURTHER REPORTED THAT LEAKAGE OCCURRED WHILE FLUSHING. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24243452 ↗
• MalfunctionNov 28, 2025Expulsion; Loosening of Implant Not Related to Bone-Ingrowth; Expulsion; Loosening of Implant Not Related to Bone-Ingrowth

  A PATIENT UNDERWENT A GLIDEPATH HEMODIALYSIS CATHETER PLACEMENT PROCEDURE. DURING THE PROCEDURE, IT WAS REPORTED THAT THE CUFF HAS ALLEGEDLY CAME OUT. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23670862 ↗
• MalfunctionNov 11, 2025Stretched; Unraveled Material; Deformation Due to Compressive Stress; Detachment of Device or Device Component; Stretched; Unraveled Material; Deformation Due to Compressive Stress; Detachment of Device or Device Component

  A PATIENT UNDERWENT A DIALYSIS CATHETER PLACEMENT PROCEDURE USING THE GLIDEPATH HEMODIALYSIS CATHETER. POST THE PROCEDURE IT WAS NOTED THAT THE J WIRE FROM THE KIT CAME OUT LIKE A SLINKY. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23520118 ↗
• MalfunctionJul 1, 2025Contamination; Device Contamination with Chemical or Other Material; Contamination; Device Contamination with Chemical or Other Material

  ON (B)(6) 2025, A PATIENT UNDERWENT THE DIALYSIS CATHETER PLACEMENT PROCEDURE. IT WAS REPORTED THAT PRIOR TO THE PROCEDURE, THE LUBRICANT TYPE SUBSTANCE ALLEGEDLY APPEARED ON THE RED END OF THE DEVICE. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22369462 ↗
• MalfunctionJul 1, 2025Contamination; Nonstandard Device; Device Contaminated During Manufacture or Shipping; Contamination; Nonstandard Device; Device Contaminated During Manufacture or Shipping

  ON (B)(6) 2025, A PATIENT UNDERWENT THE DIALYSIS CATHETER PLACEMENT PROCEDURE. IT WAS REPORTED THAT PRIOR TO THE PROCEDURE, THE LUBRICANT TYPE SUBSTANCE ALLEGEDLY APPEARED ON THE RED END OF THE DEVICE. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22369085 ↗
• MalfunctionJul 1, 2025Contamination; Nonstandard Device; Device Contaminated During Manufacture or Shipping; Contamination; Nonstandard Device; Device Contaminated During Manufacture or Shipping

  ON (B)(6) 2025, A PATIENT UNDERWENT THE DIALYSIS CATHETER PLACEMENT PROCEDURE. IT WAS REPORTED THAT PRIOR TO THE PROCEDURE, THE LUBRICANT TYPE SUBSTANCE ALLEGEDLY APPEARED ON THE RED END OF THE DEVICE. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22369083 ↗
• MalfunctionJul 1, 2025Contamination; Nonstandard Device; Device Contaminated During Manufacture or Shipping; Contamination; Nonstandard Device; Device Contaminated During Manufacture or Shipping

  ON (B)(6) 2025, A PATIENT PREPPED FOR A DIALYSIS CATHETER PLACEMENT PROCEDURE USING GLIDEPATH. PRIOR TO THE PROCEDURE, THE LUBRICANT TYPE SUBSTANCE ALLEGEDLY APPEARED ON THE RED END OF THE DEVICE. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22369080 ↗
• MalfunctionJul 1, 2025Contamination; Device Contamination with Chemical or Other Material; Contamination; Device Contamination with Chemical or Other Material

  ON (B)(6) 2025, A PATIENT UNDERWENT THE DIALYSIS CATHETER PLACEMENT PROCEDURE. IT WAS REPORTED THAT PRIOR TO THE PROCEDURE, THE LUBRICANT TYPE SUBSTANCE ALLEGEDLY APPEARED ON THE RED END OF THE DEVICE. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22368927 ↗
• InjuryApr 18, 2025Material Puncture/Hole; Air/Gas in Device; Material Puncture/Hole; Air/Gas in Device

  IT WAS REPORTED THAT SOMETIMES POST A PORT PLACEMENT PROCEDURE, AIR ALLEGEDLY ENTERED LINES THROUGH RED LUMEN. FURTHER IT WAS REPORTED THAT IT WAS FOUND TO HAVE A PUNCTURE IN ONE OF THE DWELLS. REPORTEDLY CATHETER REMOVED BY IR PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 21863140 ↗
• MalfunctionFeb 25, 2025Stretched; Failure to Advance; Deformation Due to Compressive Stress; Physical Resistance/Sticking; Stretched; Failure to Advance; Deformation Due to Compressive Stress; Physical Resistance/Sticking

  IT WAS REPORTED THAT DURING A DIALYSIS CATHETER PLACEMENT PROCEDURE, THE J-WIRE ALLEGEDLY WOULD NOT PASS THROUGH THE INCLUDED HOLLOW STYLET. IT WAS FURTHER REPORTED THAT THE PHYSICIAN PASSED THE REPLACEMENT CATHETER DIRECTLY OVER THE WIRE (WITHOUT THE STYLET). IT WAS FURTHER REPORTED THAT THE J WIRE WOULD NOT PASS THROUGH THE STYLET SO THERE WAS RESISTANCE MET. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21455472 ↗
• InjuryJun 26, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THROUGH LITIGATION PROCESS THAT SOMETIME POST A DIALYSIS CATHETER PLACEMENT, THE PATIENT ALLEGEDLY DEVELOPED ARRHYTHMIA, TACHYCARDIA AND CARDIOMEGALY. IT WAS FURTHER REPORTED THAT PATIENT HAD PAIN. HOWEVER, THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Abscess; Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Arrhythmia; Pain; Sepsis; Tachycardia

  MAUDE report 19612692 ↗
• MalfunctionJun 17, 2024Deformation Due to Compressive Stress; Deformation Due to Compressive Stress

  IT WAS REPORTED THAT DURING A DIALYSIS CATHETER PLACEMENT PROCEDURE THROUGH RIGHT INTERNAL JUGULAR VEIN APPROACH, THE CATHETER WAS ALLEGEDLY KINKED. THE PROCEDURE WAS COMPLETED BY USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19545093 ↗
• MalfunctionMar 5, 2024Fracture; Difficult to Remove; Material Separation; Stretched; Unraveled Material; Failure to Advance; Physical Resistance/Sticking; Fracture; Difficult to Remove; Material Separation; Stretched; Unraveled Material; Failure to Advance; Physical Resistance/Sticking

  IT WAS REPORTED THAT DURING A DIALYSIS CATHETER PLACEMENT PROCEDURE, THE GUIDEWIRE ALLEGEDLY COULD NOT BE PASSED THROUGH THE PUNCTURE NEEDLE AND IT ALLEGEDLY BECAME STUCK. IT WAS FURTHER REPORTED THAT THE GUIDEWIRE WAS ALLEGEDLY DIFFICULT TO BE RETRACTED. FURTHERMORE, THE GUIDEWIRE ALLEGEDLY BROKE WHILE ATTEMPTING TO PULL IT BACK. THE PROCEDURE WAS COMPLETED BY USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18835564 ↗
• InjuryFeb 14, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT SOMETIMES POST A DIALYSIS CATHETER PLACEMENT, THE PATIENT ALLEGEDLY EXPERIENCED INFECTION. THE CURRENT STATUS OF THE PATIENT WAS UNKNOWN.

  Patient problems: Unspecified Infection

  MAUDE report 18701414 ↗
• MalfunctionFeb 13, 2024Loss of or Failure to Bond; Difficult to Remove; Loss of or Failure to Bond; Difficult to Remove

  IT WAS REPORTED THAT SOMETIME POST A DIALYSIS CATHETER PLACEMENT, WHEN THE CUFF WAS PEELED OFF TO REMOVE THE CATHETER, THE CATHETER COULD NOT BE REMOVED AT ALL AND THE CUFF WAS ALLEGEDLY STUCK. IT WAS FURTHER REPORTED THAT A GUIDEWIRE WAS INSERTED AND ATTEMPT WAS MADE TO REMOVE THE CUFF, BUT THE CUFF CANNOT BE REMOVED AT ALL. FURTHERMORE, THE CUFF WAS KEPT IN PLACE IN A DETACHED STATE. REPORTEDLY, THE CATHETER WAS REMOVED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18693963 ↗
• MalfunctionNov 27, 2023Deformation Due to Compressive Stress; Material Deformation; Air/Gas in Device; Deformation Due to Compressive Stress; Material Deformation; Air/Gas in Device

  IT WAS REPORTED THAT DURING A DIALYSIS CATHETER PLACEMENT PROCEDURE, THE CATHETER WAS ALLEGEDLY KINKED. IT WAS FURTHER REPORTED THAT AN ATTEMPT WAS DONE TO CHECK FOR BLEEDING FROM BOTH ARTERIAL AND VENOUS LUMENS, BUT ONLY AIR WAS DRAWN. THE PROCEDURE WAS COMPLETED BY USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18207943 ↗
• InjuryNov 16, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A DIALYSIS CATHETER PLACEMENT PROCEDURE, THE SHEATH WAS ALLEGEDLY FOUND TO HAVE DAMAGED A BLOOD VASCULAR WALL DURING INSERTION OF THE SHEATH. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Perforation of Vessels

  MAUDE report 18150727 ↗
• MalfunctionJul 7, 2023Material Opacification; Deformation Due to Compressive Stress; Material Opacification; Deformation Due to Compressive Stress

  IT WAS REPORTED THAT TWO YEARS FIVE MONTHS AND FIVE DAYS POST A DIALYSIS CATHETER PLACEMENT, THE CATHETER ALLEGEDLY BENT. IT WAS FURTHER REPORTED THAT THE CATHETER ALLEGEDLY IN MILKY APPEARANCE BELOW THE HUB. REPORTEDLY, THE CATHETER WAS REMOVED AND REPLACED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17277238 ↗
• MalfunctionApr 21, 2023Material Discolored; Material Opacification; Stretched; Material Discolored; Material Opacification; Stretched

  IT WAS REPORTED THAT DURING A DIALYSIS CATHETER PLACEMENT PROCEDURE, THE CATHETER ALLEGEDLY CHANGED TO MILKY COLOUR. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16789899 ↗
• MalfunctionNov 26, 2021Stretched; Deformation Due to Compressive Stress; Material Protrusion/Extrusion; Stretched; Deformation Due to Compressive Stress; Material Protrusion/Extrusion

  IT WAS REPORTED THAT SOME TIME POST DIALYSIS CATHETER PLACEMENT THROUGH THE RIGHT INTERNAL JUGULAR VEIN, THE VENOUS PORT OF THE CATHETER ALLEGEDLY APPEARED TO BE STRETCHED DUE TO A PULL OR BEING UNDER PRESSURE. IT WAS FURTHER REPORTED THAT CATHETER WAS REMOVED FROM THE PATIENT. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12878099 ↗
• MalfunctionAug 17, 2020Collapse; Collapse

  IT WAS REPORTED THAT SOMETIME POST DIALYSIS CATHETER PLACEMENT, IT WAS ALLEGED THAT THERE IS COLLAPSING OF THE LIMBS OF THE DIALYSIS CATHETERS. TREATED WITH CATHFLOW. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10412434 ↗
• MalfunctionJul 23, 2019Defective Component; Defective Component

  IT WAS REPORTED THAT PRIOR TO THE PLACEMENT OF THE DIALYSIS CATHETER, THE TIP OF THE TUNNELER ALLEGEDLY BROKE. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Patient Involvement

  MAUDE report 8819298 ↗
• MalfunctionJul 12, 2019Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT DURING PREPARATION, DURING DIALYSIS CATHETER FLUSH, SALINE ALLEGEDLY LEAKED OUT OF SEVERAL PINHOLES FOUND IN THE CATHETER. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Patient Involvement

  MAUDE report 8786274 ↗
• MalfunctionJun 14, 2019Defective Component; Defective Component

  IT WAS REPORTED THAT DURING DIALYSIS CATHETER INSERTION, THE PLASTIC STEM OF THE TUNNELER COMPONENT ALLEGEDLY BROKE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8700170 ↗
• MalfunctionApr 29, 2019Defective Component; Defective Component

  IT WAS REPORTED THE TUNNELER ALLEGEDLY CRACKED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8562006 ↗