GlidePath Long-Term Hemodialysis Catheter 5396240Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00801741012259), received between Dec 5, 2022 and Mar 4, 2026 — classified as 6 malfunctions.

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

Most reported problems

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 4, 2026Fracture; Material Separation; Stretched; Failure to Advance; Deformation Due to Compressive Stress

  ON (B)(6) 2025, A PATIENT UNDERWENT A DIALYSIS CATHETER PLACEMENT PROCEDURE USING THE GLIDEPATH HEMODIALYSIS CATHETER. DURING THE PROCEDURE, THE GUIDEWIRE COULD NOT PASS THROUGH THE INTRODUCER NEEDLE. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24514133 ↗
• MalfunctionJul 9, 2025Deformation Due to Compressive Stress; Deformation Due to Compressive Stress

  ON (B)(6) 2025, A PATIENT UNDERWENT FOR A DIALYSIS CATHETER PLACEMENT PROCEDURE USING GLIDEPATH. DURING A GLIDEPATH DIALYSIS CATHETER PROCEDURE, THE CATHETER WAS KINKED WHEN INSERTED. IT WAS FURTHER REPORTED THAT A NEW PRODUCT WAS USED, AND THE PROCEDURE WAS COMPLETED WITHOUT INCIDENT. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22454883 ↗
• MalfunctionMar 25, 2024Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT DURING A DIALYSIS CATHETER PLACEMENT PROCEDURE, THE CATHETER TIP OF THE DEVICE WAS ALLEGEDLY DAMAGED WHEN CONNECTING THE CATHETER TO THE TUNNELER. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18967029 ↗
• MalfunctionDec 9, 2023Nonstandard Device; Contamination /Decontamination Problem; Nonstandard Device; Contamination /Decontamination Problem

  IT WAS REPORTED THAT PRIOR TO A DIALYSIS CATHETER PLACEMENT PROCEDURE, A HAIR WAS ALLEGEDLY PRESENT LAYING ON TOP OF THE CATHETER LINE INSIDE THE PROTECTIVE PACKAGE. THE PROCEDURE WAS COMPLETED BY USING ANOTHER DEVICE. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18298122 ↗
• MalfunctionSep 16, 2023Fracture; Difficult to Insert; Stretched; Deformation Due to Compressive Stress; Physical Resistance/Sticking; Fracture; Difficult to Insert; Stretched; Deformation Due to Compressive Stress; Physical Resistance/Sticking

  IT WAS REPORTED THAT DURING A DIALYSIS CATHETER PLACEMENT PROCEDURE, THERE WAS STRONG RESISTANCE FELT DURING INSERTING THE GUIDEWIRE, AFTER PUNCTURING THE NEEDLE. IT WAS FURTHER REPORTED THAT THE DEVICE ALLEGEDLY BROKEN UPON REMOVAL. REPORTEDLY, ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17761954 ↗
• MalfunctionDec 5, 2022Fluid/Blood Leak; Fracture; Fluid/Blood Leak; Fracture

  IT WAS REPORTED THAT PRIOR TO A CATHETER PLACEMENT PROCEDURE, THE LUER-LOCK CONNECTOR OF THE CATHETER WAS ALLEGEDLY CRACKED. IT WAS FURTHER REPORTED THAT THE SALINE WAS ALLEGEDLY LEAKED UPON FLUSHING. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15913473 ↗