GlidePath Long-Term Hemodialysis Catheter with Preloaded Stylet 5393190Recalls & reported problems

Summary

The FDA's MAUDE database contains 107 adverse event reports that list this exact device (DI 00801741012174), received between May 4, 2017 and Mar 12, 2026 — classified as 22 injuries, 85 malfunctions.

The most frequently reported specific device problem is “Defective Component” (25 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 25 most recent of 107 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

  A PATIENT UNDERWENT A DIALYSIS CATHETER PLACEMENT PROCEDURE USING GLIDEPATH HEMODIALYSIS CATHETER. POST PROCEDURE, IT WAS NOTED THAT THE CATHETER HAD EXTRUDED. 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 24580379 ↗
• InjuryNov 28, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A PATIENT UNDERWENT A DIALYSIS CATHETER PLACEMENT PROCEDURE USING GLIDEPATH. POST THE PROCEDURE, THE PATIENT ALLEGEDLY EXPERIENCED INFECTION. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Unspecified Infection

  MAUDE report 23669794 ↗
• MalfunctionNov 27, 2025Expulsion; Loosening of Implant Not Related to Bone-Ingrowth; Expulsion; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT DURING A GLIDEPATH HEMODIALYSIS CATHETER PLACEMENT, THE CUFF ALLEGEDLY CAME OUT. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23665244 ↗
• InjuryAug 29, 2025Fracture; Fracture

  ON (B)(6) 2025, A 28-YEARS-OLD FEMALE PATIENT UNDERWENT A DIALYSIS CATHETER PLACEMENT PROCEDURE USING GLIDEPATH. DURING THE PROCEDURE, THE CLAMP WAS ALLEGEDLY FOUND BROKEN AND FURTHER REPORTED THAT THE PATIENT SENT TO EMERGENCY DEPARTMENT FROM DIALYSIS CENTER WITH BROKEN BLUE CLAMP. THE CURRENT STATUS OF THE PATIENT WAS UNKNOWN.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 22921555 ↗
• MalfunctionAug 29, 2025Deformation Due to Compressive Stress; Deformation Due to Compressive Stress

  A PATIENT UNDERWENT A DIALYSIS CATHETER PLACEMENT PROCEDURE USING GLIDEPATH. DURING THE PROCEDURE, IT WAS REPORTED THAT THE CATHETER WAS ALLEGEDLY FOUND KINKED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22920571 ↗
• InjuryAug 25, 2025Fracture; Fracture

  ON (B)(6) 2025, A FEMALE PATIENT UNDERWENT A DIALYSIS CATHETER PLACEMENT PROCEDURE USING GLIDEPATH. DURING THE PROCEDURE, THE CLAMP WAS ALLEGEDLY FOUND BROKEN AND FURTHER REPORTED THAT THE PATIENT SENT TO EMERGENCY DEPARTMENT FROM SMOKEY POINT DIALYSIS CENTER WITH BROKEN BLUE CLAMP. THE CURRENT STATUS OF THE PATIENT WAS UNKNOWN.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 22882347 ↗
• MalfunctionAug 21, 2025Difficult to Remove; Stretched; Failure to Advance; Deformation Due to Compressive Stress; Physical Resistance/Sticking; Difficult to Remove; Stretched; Failure to Advance; Deformation Due to Compressive Stress; Physical Resistance/Sticking

  A PATIENT UNDERWENT FOR DIALYSIS CATHETER PLACEMENT PROCEDURE USING GLIDEPATH. DURING THE PROCEDURE, THE GUIDEWIRE ALLEGEDLY COULD NOT ADVANCE BEYOND FRONT OF THE STYLET AND COULD NOT REMOVE. REPORTEDLY GUIDEWIRE AND CATHETER BECAME STUCK AND WERE REMOVED TOGETHER. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22858499 ↗
• InjuryAug 13, 2025Fracture; Fracture

  A PATIENT UNDERWENT A DIALYSIS CATHETER PLACEMENT PROCEDURE USING THE GLIDEPATH. IT WAS REPORTED THAT SOMETIME POST PROCEDURE, THE CLAMP WAS ALLEGEDLY FOUND BROKEN. IT WAS FURTHER REPORTED THAT SEVERAL PATIENTS HAVE PRESENTED TO IR WITH BROKEN CLAMPS. THE CURRENT STATUS OF THE PATIENT WAS UNKNOWN.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 22791368 ↗
• MalfunctionJul 12, 2025Fracture; Fracture

  A PATIENT UNDERWENT FOR DIALYSIS CATHETER PLACEMENT PROCEDURE USING GLIDEPATH. ON (B)(6) 2025, DURING A DIALYSIS CATHETER PLACEMENT PROCEDURE, THE CATHETER REPAIR KITS WERE ALLEGEDLY FOUND WITH BROKEN CLAMPS ON GLIDEPATH. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22488242 ↗
• MalfunctionJul 12, 2025Fracture; Fracture

  A PATIENT UNDERWENT FOR DIALYSIS CATHETER PLACEMENT PROCEDURE USING GLIDEPATH. ON (B)(6) 2025, DURING DIALYSIS CATHETER PLACEMENT PROCEDURE, THE CATHETER REPAIR KITS WERE ALLEGEDLY FOUND WITH BROKEN CLAMPS. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22488241 ↗
• MalfunctionJul 11, 2025Fracture; Fracture

  A PATIENT UNDERWENT FOR DIALYSIS CATHETER PLACEMENT PROCEDURE USING GLIDEPATH. ON (B)(6) 2025, THE CLAMP ALLEGEDLY BROKE. THE CATHETER WAS REPAIRED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22478940 ↗
• MalfunctionJul 11, 2025Fracture; Fracture

  A PATIENT UNDERWENT FOR DIALYSIS CATHETER PLACEMENT PROCEDURE USING GLIDEPATH. ON (B)(6) 2025, THE CATHETER WAS ALLEGEDLY BROKEN. THE CATHETER WAS REPAIRED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22478938 ↗
• MalfunctionJul 11, 2025Fracture; Fracture

  A PATIENT UNDERWENT FOR DIALYSIS CATHETER PLACEMENT PROCEDURE USING GLIDEPATH. ON (B)(6) 2025, THE CLAMP WAS ALLEGEDLY BROKEN. THE CATHETER WAS REPAIRED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22478936 ↗
• InjuryJul 7, 2025Fracture; Fracture

  A PATIENT UNDERWENT FOR A DIALYSIS CATHETER PLACEMENT USING GLIDEPATH. DURING THE PROCEDURE, THE CLAMP WAS ALLEGEDLY FOUND BROKEN. IT WAS FURTHER REPORTED THAT SEVERAL PATIENTS HAVE PRESENTED TO IR WITH BROKEN CLAMPS. HOWEVER, THE CURRENT STATUS OF THE PATIENT WAS UNKNOWN.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 22409548 ↗
• InjuryJul 7, 2025Fracture; Fracture

  A PATIENT UNDERWENT FOR A DIALYSIS CATHETER PLACEMENT USING GLIDEPATH. DURING THE PROCEDURE, THE CLAMP WAS ALLEGEDLY FOUND BROKEN. IT WAS FURTHER REPORTED THAT SEVERAL PATIENTS HAVE PRESENTED TO IR WITH BROKEN CLAMPS. HOWEVER, THE CURRENT STATUS OF THE PATIENT WAS UNKNOWN.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 22409547 ↗
• InjuryJul 7, 2025Fracture; Fracture

  A PATIENT UNDERWENT FOR A DIALYSIS CATHETER PLACEMENT USING GLIDEPATH. DURING THE PROCEDURE, THE CLAMP WAS ALLEGEDLY FOUND BROKEN. IT WAS FURTHER REPORTED THAT SEVERAL PATIENTS HAVE PRESENTED TO IR WITH BROKEN CLAMPS. HOWEVER, THE CURRENT STATUS OF THE PATIENT WAS UNKNOWN.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 22409543 ↗
• MalfunctionJun 18, 2025Loss of or Failure to Bond; Fracture; Material Separation; Deformation Due to Compressive Stress; Migration; Loss of or Failure to Bond; Fracture; Material Separation; Deformation Due to Compressive Stress; Migration

  A PATIENT UNDERWENT A DIALYSIS CATHETER USING GLIDEPATH DIALYSIS CATHETER. SOMETIMES POST A DIALYSIS CATHETER PLACEMENT PROCEDURE, THE CUFF IS HAVING ISSUES ADHERING THE CHEST WALL AFTER ABOUT A YEAR AFTER PLACEMENT. THIS CAUSES THE CATHETER TO MOVE WITHIN THE BODY. REMOVED FROM PATIENT AND IMPLANTED A PICC LINE. THEY HAVE NOT CHANGED ANY OF THE CLEANING OR DRESSING PRODUCTS THAT THEY USE. THE EXTERNAL PART OF THE CATHETERS STARTS TO TWIST AND DEFORMED.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 22283533 ↗
• InjuryApr 21, 2025Restricted Flow rate; Suction Problem; Restricted Flow rate; Suction Problem

  IT WAS REPORTED THAT SOMETIME POST A DIALYSIS CATHETER PLACEMENT, THE CATHETER WAS ALLEGEDLY NOT LOCATED AT THE JOINING OF THE SUPERIOR VENA CAVA/RIGHT HEART, BUT SLIGHTLY DISTAL TO THE INFERIOR PART OF THE VEIN. IT WAS FURTHER REPORTED THAT THE PATIENT HAD EXPERIENCED POOR BLEEDING. REPORTEDLY, PATIENT HAD EXPERIENCED BLOOD CLOT AND POOR FLOW. THE CURRENT STATUS OF THE PATIENT WAS UNKNOWN.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 21870883 ↗
• InjuryApr 14, 2025Fracture; Material Separation; Fracture; Material Separation

  IT WAS REPORTED THAT SOMETIMES POST A DIALYSIS CATHETER PLACEMENT, THE PATIENT ALLEGEDLY HAD AN INFECTION, AND THE DIALYSIS CATHETER WAS REMOVED. IT WAS FURTHER REPORTED THAT THE CATHETER ALLEGEDLY BROKE BY THE CUFF DURING THE REMOVAL. ADDITIONALLY, THE REMAINING PIECE WAS REMOVED BY CUTTING DOWN ON THE REMAINING PIECE. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Bacterial Infection; Fever; Unspecified Infection

  MAUDE report 21832305 ↗
• MalfunctionApr 3, 2025Expulsion; Loosening of Implant Not Related to Bone-Ingrowth; Expulsion; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT SOMETIME POST A DIALYSIS CATHETER PLACEMENT, THE CUFF IS ALLEGEDLY NOT ADHERING TO THE CHEST WALL. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21760573 ↗
• MalfunctionFeb 26, 2025Collapse; Restricted Flow rate; Suction Problem; Deformation Due to Compressive Stress; Expulsion; Collapse; Restricted Flow rate; Suction Problem; Deformation Due to Compressive Stress; Expulsion

  IT WAS REPORTED THAT ONE YEAR AND THIRTY DAYS POST A DIALYSIS CATHETER PLACEMENT, THE CATHETER WAS ALLEGEDLY KINKING WHERE IT IS CLAMPED. IT WAS FURTHER REPORTED THAT THERE WAS REDUCED BLOOD FLOW. ADDITIONALLY, THE STEM OF THE TUBING COMING OUT OF THE CHEST WALL AT THE EXIT SITE STARTED TO COLLAPSE DURING THE TREATMENT. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21466896 ↗
• MalfunctionFeb 18, 2025Fracture; Material Separation; Fracture; Material Separation

  IT WAS REPORTED THAT DURING INSTALLATION OF A DIALYSIS CATHETER PLACEMENT PROCEDURE IN THE RIGHT INTERNAL JUGULAR VEIN, THE DEVICE ALLEGEDLY BROKE ALMOST IN TWO DIFFERENT PIECES WHILE BEING SUTURED INTO THE PATIENT. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21394896 ↗
• MalfunctionJan 23, 2025Fracture; Difficult to Insert; Material Separation; Stretched; Fracture; Difficult to Insert; Material Separation; Stretched

  IT WAS REPORTED THAT DURING A DIALYSIS CATHETER PLACEMENT PROCEDURE VIA THE RIGHT INTERNAL JUGULAR VEIN APPROACH, THE GUIDEWIRE WAS ALLEGEDLY DIFFICULT TO INSERT INTO THE DILATOR. THE PROCEDURE WAS COMPLETED BY USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21215447 ↗
• MalfunctionJan 6, 2025Deformation Due to Compressive Stress; Material Integrity Problem; Deformation Due to Compressive Stress; Material Integrity Problem

  IT WAS REPORTED THAT SOMETIMES POST A DIALYSIS CATHETER PLACEMENT, THERE WAS DAMAGE AND KINK NOTED TO THE EXTENSION LEGS TUBING. REPORTEDLY, THE TUBING WAS MANUALLY UNKINKED AND TAPED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21077072 ↗
• MalfunctionDec 20, 2024Restricted Flow rate; Deformation Due to Compressive Stress; Restricted Flow rate; Deformation Due to Compressive Stress

  IT WAS REPORTED THAT TWO MONTHS AND TWENTY-FOUR 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. REPORTEDLY, THE LINE WAS REMOVED URGENTLY BECAUSE OF A BLOOD CULTURE THAT CAME BACK POSITIVE FOR PSEUDOMONAS (NOT RELATED TO THE HEMOLINE). THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20985168 ↗