GlidePath 5343230Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00801741187407), received between May 1, 2024 and Feb 3, 2026 — classified as 1 injury, 8 malfunctions.

The most frequently reported specific device problem is “Deformation Due to Compressive Stress” (8 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 3, 2026Fluid/Blood Leak; Obstruction of Flow; Material Integrity Problem

  ON (B)(6) 2026, A PATIENT UNDERWENT A DIALYSIS CATHETER PLACEMENT PROCEDURE USING GLIDEPATH. DURING THE PROCEDURE, IT WAS REPORTED THAT BLEEDING WAS OBSERVED FROM THE CUFF-SIDE EXIT PORT IMMEDIATELY UPON DEVICE CLOGGING. REPORTEDLY, A MACROSCOPIC INSPECTION DID NOT REVEAL ANY VISIBLE TEAR; HOWEVER, WHEN A PULL-AND-PUSH ACTION WAS APPLIED FROM THE BLUE SIDE, BLOOD WAS SEEN SEEPING FROM THE TUNNEL, INDICATING AN INTERNAL LEAK. FURTHERMORE, LEAKAGE COULD NOT BE REPRODUCED WITHOUT APPLYING CONSIDERABLE FORCE, MAKING IT DIFFICULT TO IDENTIFY THE PRECISE LOCATION OF THE DAMAGE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: Extravasation; Hemorrhage/Blood Loss/Bleeding; No Clinical Signs, Symptoms or Conditions

  MAUDE report 24243043 ↗
• MalfunctionSep 4, 2025Restricted Flow rate; Deformation Due to Compressive Stress; Restricted Flow rate; Deformation Due to Compressive Stress

  ON (B)(6) 2025, A PATIENT UNDERWENT A DIALYSIS CATHETER PLACEMENT PROCEDURE USING GLIDEPATH. ON (B)(6) 2025, IT WAS REPORTED THAT POST DIALYSIS CATHETER PLACEMENT, THE DRAINAGE WAS ALLEGEDLY FOUND WITH POOR BLOOD FLOW. IT WAS FURTHER REPORTED THAT THE CATHETER WAS ALLEGEDLY FOUND KINKING. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22961379 ↗
• MalfunctionOct 15, 2024Deformation Due to Compressive Stress; Deformation Due to Compressive Stress

  IT WAS REPORTED THAT DURING A DIALYSIS CATHETER PLACEMENT PROCEDURE, THE CATHETER WAS PLACED INSIDE THE SHEATH AND PEELED AWAY. IT WAS FURTHER REPORTED THAT THE CATHETER ALLEGEDLY KINKED ABOUT TWO CENTIMETERS FROM THE CUFF. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20458301 ↗
• MalfunctionSep 12, 2024Restricted Flow rate; Suction Problem; Deformation Due to Compressive Stress; Restricted Flow rate; Suction Problem; Deformation Due to Compressive Stress

  IT WAS REPORTED THAT DURING A DIALYSIS CATHETER PLACEMENT PROCEDURE VIA THE RIGHT INTERNAL JUGULAR VEIN, THERE WAS ALLEGEDLY A KINK ABOUT TWO CENTIMETERS FROM THE CUFF UNDER FLUOROSCOPY IMAGING. IT WAS FURTHER REPORTED THAT THE FLOW RATE WAS ALLEGEDLY FOUND TO BE SLOW TO DRAIN, AND SO THE CATHETER WAS REMOVED. FURTHERMORE, THERE WERE ALLEGEDLY SOME PROBLEMS IN THE LUMEN ON THE SUCTION SIDE. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20200009 ↗
• MalfunctionJun 27, 2024Deformation Due to Compressive Stress; Deformation Due to Compressive Stress

  IT WAS REPORTED THAT DURING A DIALYSIS CATHETER PLACEMENT PROCEDURE VIA RIGHT ENDOCERVICAL APPROACH, KINK ALLEGEDLY OCCURRED WHEN INSERTING THE CATHETER INTO THE SHEATH. IT WAS FURTHER REPORTED THAT THE CATHETER WAS ADJUSTED BUT A DENT IN THE CATHETER WAS CONFIRMED. REPORTEDLY, THE CATHETER WAS REMOVED AND THE PROCEDURE WAS COMPLETED BY USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19621956 ↗
• MalfunctionJun 19, 2024Deformation Due to Compressive Stress; Deformation Due to Compressive Stress

  IT WAS REPORTED THAT DURING A DIALYSIS CATHETER PLACEMENT PROCEDURE, A KINK HAD ALLEGEDLY OCCURRED IN THE CATHETER. IT WAS FURTHER REPORTED THAT THE CATHETER WAS REMOVED. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19566508 ↗
• MalfunctionJun 12, 2024Difficult to Flush; Suction Problem; Deformation Due to Compressive Stress; Difficult to Flush; Suction Problem; Deformation Due to Compressive Stress

  IT WAS REPORTED THAT DURING A DIALYSIS CATHETER PLACEMENT PROCEDURE VIA THE RIGHT INTERNAL JUGULAR VEIN APPROACH, THE CATHETER WAS ALLEGEDLY KINKED. IT WAS FURTHER REPORTED THAT THE BLOOD DRAINAGE AND BLOOD RETURN WERE ALLEGEDLY POOR. FURTHERMORE, THE CATHETER WAS REMOVED. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19525474 ↗
• MalfunctionJun 3, 2024Deformation Due to Compressive Stress; Deformation Due to Compressive Stress

  IT WAS REPORTED THAT DURING A DIALYSIS CATHETER PLACEMENT PROCEDURE, THE CURVED PART OF THE CUFF ALLEGEDLY KINKED. REPORTEDLY, A GUIDEWIRE WAS INSERTED, AND KINK WAS RESOLVED A LITTLE BUT NOT COMPLETELY. IT WAS FURTHER REPORTED THAT POOR HEMORRHAGE ALLEGEDLY OCCURRED, AND THE GUIDEWIRE WAS INSERTED AGAIN, AND THE HEMORRHAGE WAS SECURED WITH AN ADDITIONAL INTERVENTION. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19445205 ↗
• MalfunctionMay 1, 2024Fracture; Deformation Due to Compressive Stress; Material Split, Cut or Torn; Fracture; Deformation Due to Compressive Stress; Material Split, Cut or Torn

  IT WAS REPORTED THAT DURING A DIALYSIS CATHETER PLACEMENT PROCEDURE, THE PORTION OF THE CATHETER WAS ALLEGEDLY TORN WHEN INSERTING THE CATHETER INTO THE SHEATH. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19227060 ↗