GlidePath Long-Term Hemodialysis Catheter with Preloaded Stylet 5393310Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00801741012204), received between Apr 23, 2019 and Mar 12, 2026 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Expulsion” (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 18, 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.

• MalfunctionMar 12, 2026Stretched; Expulsion; Material Protrusion/Extrusion; Loosening of Implant Not Related to Bone-Ingrowth

  ON (B)(6) 2026, A PATIENT UNDERWENT A DIALYSIS CATHETER PLACEMENT PROCEDURE USING GLIDEPATH HEMODIALYSIS CATHETER. POST THE PROCEDURE, IT WAS NOTED THAT THE CVC CUFF HAD EXTRUDED AND WAS EXPOSED. REPORTEDLY, THE CATHETER WAS REMOVED. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THE CURRENT STATUS OF THE PATIENT WAS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Skin Erosion

  MAUDE report 24577508 ↗
• MalfunctionFeb 27, 2026Stretched; Expulsion; Material Protrusion/Extrusion; Loosening of Implant Not Related to Bone-Ingrowth

  ON (B)(6) 2026, A PATIENT UNDERWENT A DIALYSIS CATHETER PLACEMENT PROCEDURE USING GLIDEPATH HEMODIALYSIS CATHETER. POST THE PROCEDURE, IT WAS NOTED THAT THE CVC CUFF HAD EXTRUDED AND WAS EXPOSED. REPORTEDLY, THE CATHETER WAS REMOVED. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THE CURRENT STATUS OF THE PATIENT WAS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Skin Erosion

  MAUDE report 24468017 ↗
• MalfunctionDec 13, 2024Incorrect, Inadequate or Imprecise Result or Readings; Low Test Results; Incorrect, Inadequate or Imprecise Result or Readings; Low Test Results

  IT WAS REPORTED THAT SOMETIME POST A DIALYSIS CATHETER PLACEMENT, WHEN BLOOD WAS COLLECTED FROM DEVICE, THE BLOOD TEST RESULTS WERE ALLEGEDLY FAINT. THERE WAS NO REPORTED PATIENT INJURY

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20923170 ↗
• MalfunctionNov 28, 2023Difficult to Insert; Deformation Due to Compressive Stress; Material Twisted/Bent; Difficult to Insert; Deformation Due to Compressive Stress; Material Twisted/Bent

  IT WAS REPORTED THAT DURING A DIALYSIS CATHETER PLACEMENT PROCEDURE VIA THE LEFT JUGULAR VEIN APPROACH, THE FOLDED PART OF THE CATHETER WAS ALLEGEDLY TWISTED AND KINKED. IT WAS FURTHER REPORTED THAT THE BLOOD WAS ALLEGEDLY NOT DRAINING WELL, AND THE CATHETER WAS REMOVED COMPLETELY. REPORTEDLY, THE CATHETER WAS TRIED TO BE REINSERTED USING SELDINGER TECHNIQUE BUT WAS NOT POSSIBLE. THE PROCEDURE WAS COMPLETED BY USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18215005 ↗
• MalfunctionJun 7, 2022Restricted Flow rate; Restricted Flow rate

  IT WAS REPORTED THROUGH RESULTS OF A CLINICAL TRIAL THAT APPROXIMATELY TWENTY ONE DAYS POST HEMODIALYSIS CATHETER PLACEMENT PROCEDURE, THE SUBJECT EXPERIENCED AN ADVERSE EVENT OF CATHETER ALLEGEDLY HAD A LOW FLOW RATE. IT WAS FURTHER REPORTED THAT THE CATHETER WAS REMOVED AND EXCHANGED SUCCESSFULLY. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14613878 ↗
• MalfunctionApr 23, 2019Break; Defective Component; Break; Defective Component

  IT WAS REPORTED THAT DURING PREPARATION FOR DIALYSIS CATHETER INSERTION, THE CONNECTING PIECE FROM THE STYLET HUB ALLEGEDLY BROKE OFF. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Consequences Or Impact To Patient; No Patient Involvement

  MAUDE report 8541901 ↗