GlidePath 5303190Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00801741187315), received between Jul 25, 2024 and Nov 22, 2024 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Fracture” (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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 22, 2024Loss of or Failure to Bond; Loss of or Failure to Bond

  IT WAS REPORTED THAT SOMETIME POST A DIALYSIS CATHETER PLACEMENT, THE CATHETERS WERE DISLODGING. IT WAS FURTHER REPORTED THAT THE CATHETER PLACED WAS TOO CLOSE TO THE EXIT SITE AND NOT ALLOWED FOR ADEQUATE TISSUE ATTACHMENT. REPORTEDLY, IT HAD AN ISSUE WITH PUTTING TOO MUCH GLUE ON THE CUFFS SO THAT THEY WERE NOT FLUFFY ENOUGH. IT AFFECTS THE TISSUE INGROWTH. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20755552 ↗
• MalfunctionNov 22, 2024Fracture; Stretched; Material Protrusion/Extrusion; Fracture; Stretched; Material Protrusion/Extrusion

  IT WAS REPORTED THAT SOMETIME POST A DIALYSIS CATHETER PLACEMENT, THE CATHETER ALLEGEDLY CRACKED AND ALLEGEDLY BALLOONED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20755408 ↗
• MalfunctionNov 21, 2024Loss of or Failure to Bond; Loosening of Implant Not Related to Bone-Ingrowth; Loss of or Failure to Bond; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT SOMETIME POST A DIALYSIS CATHETER PLACEMENT, THE CATHETERS WERE DISLODGING. IT WAS FURTHER REPORTED THAT THE CATHETER PLACED WAS TOO CLOSE TO THE EXIT SITE AND NOT ALLOWED FOR ADEQUATE TISSUE ATTACHMENT. REPORTEDLY, IT HAD AN ISSUE WITH PUTTING TOO MUCH GLUE ON THE CUFFS SO THAT THEY WERE NOT FLUFFY ENOUGH. IT AFFECTS THE TISSUE INGROWTH. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20744285 ↗
• MalfunctionNov 21, 2024Fracture; Stretched; Material Protrusion/Extrusion; Fracture; Stretched; Material Protrusion/Extrusion

  IT WAS REPORTED THAT SOMETIME POST A DIALYSIS CATHETER PLACEMENT, THE CATHETER ALLEGEDLY CRACKED AND ALLEGEDLY BALLOONED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20744088 ↗
• MalfunctionJul 25, 2024Fluid/Blood Leak; Fracture; Material Separation; Deformation Due to Compressive Stress; Fluid/Blood Leak; Fracture; Material Separation; Deformation Due to Compressive Stress

  IT WAS REPORTED THAT EIGHT MONTHS AND THIRTY DAYS POST A DIALYSIS CATHETER PLACEMENT, THE CATHETER WAS ALLEGEDLY RUPTURED. IT WAS FURTHER REPORTED THAT THE PHYSICIAN FOUND THAT THERE WAS ALLEGEDLY A LEAK AT THE CONNECTION BETWEEN THE HUB AND THE CATHETER. FURTHERMORE, KINK WAS ALSO FOUND BETWEEN THE HUB AND CATHETER. REPORTEDLY, THE CATHETER WAS REMOVED AND REPLACED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19834322 ↗