GlidePath 5303100Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00801741187285), received between Nov 20, 2024 and Nov 14, 2025 — classified as 1 injury, 2 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryNov 14, 2025Fracture; Loose or Intermittent Connection; Air/Gas in Device; Fracture; Loose or Intermittent Connection; Air/Gas in Device

  ¿ON (B)(6), A PATIENT UNDERWENT A DIALYSIS CATHETER PLACEMENT PROCEDURE USING A GLIDEPATH HEMODIALYSIS CATHETER. ON (B)(6) 2025, FOLLOWING INITIATION OF DIALYSIS TREATMENT, THE PRESENCE OF AIR BUBBLES WAS OBSERVED IN THE HEMODIALYSIS CIRCUIT, SPECIFICALLY IN THE RED LINE CONNECTED TO THE BLUE LUMEN OF THE GLIDEPATH CATHETER. NO VISIBLE FISSURES WERE INITIALLY IDENTIFIED, AS THE SUSPECTED BREAK WAS LOCATED BENEATH THE PATIENT'S TEGADERM DRESSING. THE CATHETER WAS LATER FOUND TO BE RUPTURED AT THE JUNCTION BETWEEN THE OUTER CATHETER TUBING AND THE PLASTIC HUB. THE PATIENT WAS TRANSFERRED TO INTERVENTIONAL RADIOLOGY FOR AN EMERGENCY EVALUATION OF THE DIALYSIS LINE. AFTER THE DIALYSIS LINE WAS CHANGED AND THE DEFECTIVE CATHETER WAS RETRIEVED, THE CATHETER BREAK WAS CONFIRMED. THE CURRENT STATUS OF THE PATIENT WAS UNKNOWN.

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

  MAUDE report 23551408 ↗
• MalfunctionDec 15, 2024Restricted Flow rate; Fracture; Deformation Due to Compressive Stress; Restricted Flow rate; Fracture; Deformation Due to Compressive Stress

  IT WAS REPORTED THAT THREE MONTHS AND TWENTY-ONE DAYS POST A DIALYSIS CATHETER PLACEMENT, THE OUTER PART OF THE LINES ALLEGEDLY TENDS TO REMAIN CRUSHED AT THE CLAMPS, AFFECTING THE LUMEN OF THE CATHETER. IT WAS FURTHER REPORTED THAT IT DID NOT BREAK COMPLETELY, HOWEVER IT LOOKS LIKE IT CAN'T GET BACK TO ITS ORIGINAL ROUND SHAPE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20935848 ↗
• MalfunctionNov 20, 2024Restricted Flow rate; Fracture; Deformation Due to Compressive Stress; Restricted Flow rate; Fracture; Deformation Due to Compressive Stress

  IT WAS REPORTED THAT THREE MONTHS AND NINETEEN DAYS POST DIALYSIS CATHETER PLACEMENT PROCEDURE, THE OUTER PART OF THE LINES ALLEGEDLY TENDS TO REMAIN CRUSHED AT THE CLAMPS, AFFECTING THE LUMEN OF THE CATHETER. IT WAS FURTHER REPORTED THAT IT DID NOT BREAK COMPLETELY, HOWEVER IT LOOKS LIKE IT CANNOT GET BACK TO ITS ORIGINAL ROUND SHAPE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20732757 ↗