GlidePath 5304150Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00801741187308), received between Jan 26, 2023 and Mar 12, 2024 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Fracture” (4 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 12, 2024Loss of or Failure to Bond; Fracture; Difficult to Insert; Material Separation; Loss of or Failure to Bond; Fracture; Difficult to Insert; Material Separation

  IT WAS REPORTED THAT DURING A DIALYSIS CATHETER PLACEMENT PROCEDURE, THE VALVE OF THE PEEL AWAY INTRODUCER WAS ALLEGEDLY BROKEN OFF. IT WAS FURTHER REPORTED THAT THE CATHETER WAS ALLEGEDLY DIFFICULT TO INSERT THROUGH THE PEEL AWAY SHEATH. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18885162 ↗
• MalfunctionSep 20, 2023Fracture; Fracture

  IT WAS REPORTED THAT THREE MONTHS AND TWENTY DAYS POST DIALYSIS CATHETER PLACEMENT, THE CLAMP OF VENOUS LIMB OF THE HEMODIALYSIS CATHETER ALLEGEDLY BROKE. REPORTEDLY, THE CATHETER WAS REPAIRED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17778710 ↗
• MalfunctionApr 4, 2023Fracture; Fracture

  IT WAS REPORTED THAT SOMETIME POST DIALYSIS CATHETER PLACEMENT PROCEDURE, THE CLIP OF VENOUS LIMB OF HEMODIALYSIS CATHETER ALLEGEDLY BROKE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16674175 ↗
• MalfunctionJan 26, 2023Material Discolored; Fracture; Material Deformation; Material Discolored; Fracture; Material Deformation

  IT WAS REPORTED THAT APPROXIMATELY SIX MONTHS POST DIALYSIS CATHETER PLACEMENT, THE CATHETER ALLEGEDLY CRACKED. IT WAS FURTHER REPORTED THAT, THE DEVICE WAS REMOVED. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16245229 ↗