GlidePath 5343190Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00801741187391), received between Jul 31, 2024 and Jan 14, 2026 — classified as 1 injury, 5 malfunctions.

The most frequently reported specific device problem is “Material Separation” (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 16, 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.

• MalfunctionJan 14, 2026Suction Problem; Malposition of Device

  ON (B)(6) 2025, A PATIENT UNDERWENT FOR A DIALYSIS CATHETER PLACEMENT PROCEDURE USING GLIDEPATH. DURING A DIALYSIS CATHETER PLACEMENT PROCEDURE, THE CATHETER TIP WAS ALLEGEDLY POSITIONED SHALLOWER THAN INTENDED, RESULTING IN POOR BLOOD WITHDRAWAL. DUE TO INSUFFICIENT DEPTH AND INADEQUATE BLOOD RETURN, THE CATHETER WAS REMOVED AND REPLACED WITH A LONGER SIZE CATHETER TO ACHIEVE PROPER PLACEMENT. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24064967 ↗
• InjuryNov 25, 2025Loss of or Failure to Bond; Material Separation; Improper or Incorrect Procedure or Method; Loss of or Failure to Bond; Material Separation; Improper or Incorrect Procedure or Method

  ON NOV 04, 2025, IT WAS REPORTED THAT AFTER REMOVING A 13F X 19CM GLIDEPATH CATHETER FROM A PATIENT, THE CUFF WAS FOUND TO BE DETACHED FROM THE CATHETER. THE CUFF WAS SUBSEQUENTLY RETRIEVED FROM THE SOFT TISSUE, AND IT WAS NOTED THAT BOTH THE CUFF AND A SLEEVE PORTION OF THE CATHETER HAD SEPARATED FROM THE ORIGINAL DEVICE. FURTHER PROBING AND DISSECTION WITH INSTRUMENTS AND ULTRASOUND GUIDANCE USED TO VISUALLY SEE AND REMOVE THE CUFF PORTION. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; No Clinical Signs, Symptoms or Conditions

  MAUDE report 23641577 ↗
• MalfunctionAug 25, 2025Loss of or Failure to Bond; Expulsion; Loss of or Failure to Bond; Expulsion

  ON (B)(6) 2025 A PATIENT UNDERWENT A DIALYSIS CATHETER PLACEMENT BY USING GLIDEPATH. DURING THE PROCEDURE, THE CUFF ALLEGEDLY SLIPPED OFF WHILE MANIPULATING THE POSITION. IT WAS FURTHER REPORTED THAT IT WAS REPOSITIONED WITH FLUOROSCOPY AND NOTICED THAT THE CATHETER WAS MOVING BUT THE CUFF REMAINED IN PLACE. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22882331 ↗
• MalfunctionApr 1, 2025Contamination /Decontamination Problem; Connection Problem; Contamination /Decontamination Problem; Connection Problem

  IT WAS REPORTED THAT PRIOR TO A DIALYSIS CATHETER PLACEMENT PROCEDURE, THE TUNNELER AND THE CATHETER CONNECTION WAS ALLEGEDLY NOT MADE WELL. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21737950 ↗
• MalfunctionMar 5, 2025Fracture; Material Separation; Detachment of Device or Device Component; Fracture; Material Separation; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A DIALYSIS CATHETER PLACEMENT PROCEDURE, THE CONNECTION OF THE CUFF ALLEGEDLY CAME OFF WHEN THE PROTECTIVE CAP OF THE TUNNELER WAS REMOVED. THE PROCEDURE WAS COMPLETED BY USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21527159 ↗
• MalfunctionJul 31, 2024Fracture; Material Separation; Fracture; Material Separation

  IT WAS REPORTED THAT SOMETIME POST A DIALYSIS CATHETER PLACEMENT, THE PIECE OF PLASTIC ALLEGEDLY BROKE OFF OF CATHETER UPON REMOVAL. IT WAS FURTHER REPORTED THAT THE PATIENT ALLEGEDLY EXPERIENCED PAIN. FURTHERMORE, THERE IS NO INFORMATION REGARDING MEDICAL INTERVENTION NOR MEDICATIONS PRESCRIBED TO TREAT PAIN. REPORTEDLY, THE CATHETER WAS REMOVED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19875207 ↗