GlidePath 5303120Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00801741187292), received between Oct 16, 2020 and Jan 31, 2023 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Device Markings/Labelling Problem” (2 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 16, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 31, 2023Fracture; Fracture

  IT WAS REPORTED THAT SIX MONTH POST DIALYSIS CATHETER IMPLANT, THE WHITE SHEATH AT THE CATHETER LUMEN JUNCTION ALLEGEDLY BROKE DOWN. IT WAS FURTHER REPORTED THAT THE CATHETER WAS REPLACED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16269887 ↗
• MalfunctionOct 20, 2020Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT PRIOR TO THE PLACEMENT OF DIALYSIS CATHETER , THE DEVICE ALLEGEDLY HAD A LABELING PROBLEM. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10703579 ↗
• MalfunctionOct 16, 2020Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT PRIOR TO A PROCEDURE, THE DEVICE WAS ALLEGEDLY FOUND TO BE MISLABELED. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10693311 ↗