GlidePath Long-Term Hemodialysis Catheter with Preloaded Stylet 5397270Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00801741012310), received between Apr 12, 2017 and Oct 21, 2025 — classified as 2 injuries, 6 malfunctions.

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

• InjuryOct 21, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THROUGH LITIGATION PROCESS THAT SOMETIME LATER PORT PLACEMENT PROCEDURE, THE PATIENT ALLEGEDLY DEVELOPED WITH BLOOD CLOT. HOWEVER, THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 23345208 ↗
• MalfunctionJan 2, 2025Loss of or Failure to Bond; Restricted Flow rate; Nonstandard Device; Deformation Due to Compressive Stress; Loss of or Failure to Bond; Restricted Flow rate; Nonstandard Device; Deformation Due to Compressive Stress

  IT WAS REPORTED THAT THREE MONTHS AND TWENTY-SEVEN DAYS POST A DIALYSIS CATHETER PLACEMENT, THE CATHETER MARKS BEGAN TO APPEAR IN THE TUBES WHERE THE CLAMPS HAD BEEN CLOSED. IT WAS FURTHER REPORTED THAT THIS ALLEGEDLY CAUSED SUCTION DURING DIALYSIS. REPORTEDLY, THE FLOW WAS COMPROMISED AND THE CUFF WAS MOVED DURING DIALYSIS. FURTHERMORE, THE PROBLEM CONTINUED TO INCREASE GRADUALLY AND NEED TO BE REPLACED SOON. EVIDENTLY, A DIFFERENT TYPE OF MATERIAL SHOULD BE USED FOR THE HOSE PIECE WITH CLAMPS. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21053375 ↗
• MalfunctionJan 2, 2025Loss of or Failure to Bond; Restricted Flow rate; Deformation Due to Compressive Stress; Loosening of Implant Not Related to Bone-Ingrowth; Loss of or Failure to Bond; Restricted Flow rate; Deformation Due to Compressive Stress; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT SOMETIMES POST A DIALYSIS CATHETER PLACEMENT, THE LEGS OF THE CATHETER WERE ALLEGEDLY TWISTED, CAUSED ALARMS AND INSUFFICIENT DIALYSIS WITH THE RISK OF HEMODIALYSIS. REPORTEDLY, IT WAS NOT POSSIBLE TO DISCONTINUE SUTURES AFTER THE 6 WEEKS, AS THE CUFF HAD NOT GROWN FIRM. FURTHERMORE, THE FLOW WAS COMPROMISED, AND CUFF WAS MOVED DURING DIALYSIS. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21052747 ↗
• MalfunctionJul 8, 2022Fluid/Blood Leak; Material Puncture/Hole; Fluid/Blood Leak; Material Puncture/Hole

  IT WAS REPORTED THAT TEN DAYS POST DIALYSIS CATHETER PLACEMENT PROCEDURE, THE CATHETER WAS ALLEGEDLY FOUND PUNCTURED IN THE EXTENSION TUBING. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14953263 ↗
• MalfunctionApr 5, 2021Fracture; Fracture

  IT WAS REPORTED THAT DURING A TUNNELING PROCEDURE, THE CATHETER ALLEGEDLY ENDED UP SPLITTING AT THE DISTAL TIP. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11612468 ↗
• MalfunctionOct 24, 2018Material Deformation; Material Deformation

  IT WAS REPORTED THAT THE ARTERIAL LUMEN COLLAPSED DURING DIALYSIS. THE DEVICE WAS REMOVED AND REPLACED IN IR (INTERVENTIONAL RADIOLOGY). THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8001838 ↗
• MalfunctionOct 23, 2018Material Deformation; Material Deformation

  IT WAS REPORTED THAT THE ARTERIAL LUMEN COLLAPSED DURING DIALYSIS. THE DEVICE WAS REMOVED AND REPLACED IN IR (INTERVENTIONAL RADIOLOGY). THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7997486 ↗
• InjuryApr 12, 2017Material Too Rigid or Stiff; Use of Device Problem; Device Operates Differently Than Expected

  IT WAS REPORTED BY THE FACILITY THAT DURING STANDARD PLACEMENT OF CATHETER IN LEFT IJ THE CATHETER PUNCTURED THE CARDIAC SPACE AND THE PATIENT STOPPED BREATHING AND CODED ON THE TABLE. THEY SUCCESSFULLY REVIVED THE PATIENT, DREW OUT THE FLUID AND PATIENT IS RECOVERING. PHYSICIAN HAD REPORTEDLY USED GLIDEPATH FOR MANY YEARS AND HAD NEVER EXPERIENCED ANY SUCH INCIDENT. 3/28/2017 - THE INSERTING CLINICIAN REPORTED THE VENOUS PATH FROM THE LEFT IJ WAS "NORMAL" AND THAT THERE WAS NO DIFFICULTY ENCOUNTERED DURING THE INSERTION PROCEDURE. HE DID STATE THE DEVICE WAS "RELATIVELY STIFF AND HAS A POINTED TIP". THE DILATOR/PEEL-AWAY SHEATH WAS SAID TO BE INSERTED TO THE DISTAL INNOMINATE VEIN, THE GUIDEWIRE IN THE IVC, AND THE CATHETER WAS INSERTED THROUGH THE SHEATH WITHOUT A WIRE AND IT ALLEGEDLY PERFORATED THE SVC, ENDING UP NEAR THE RIGHT ATRIUM. THE CLINICIAN REPORTS THE PATIENT BEGAN TO DECLINE AND STOPPED BREATHING APPROXIMATELY 5-10 MINUTES AFTER THE PROCEDURE WAS COMPLETED. CPR WAS PROVIDED FOR ABOUT 5 MINUTES BUT THE PATIENT HAD NO DOCUMENTED LOSS OF PULSES. THE PATIENT DID HAVE HYPOTENSION AND BRADYCARDIA. THERE WAS SAID TO BE APPROXIMATELY 120ML OF BLOOD LOST DURING THE PROCEDURE

  Patient problems: Bradycardia; Cardiac Perforation; Cardiopulmonary Arrest; Exsanguination; Low Blood Pressure/ Hypotension; Pericardial Effusion

  MAUDE report 6485796 ↗