GlidePath Long-Term Hemodialysis Catheter with Preloaded Stylet 5397230Recalls & reported problems

Summary

The FDA's MAUDE database contains 41 adverse event reports that list this exact device (DI 00801741012303), received between May 18, 2018 and Nov 30, 2025 — classified as 1 death, 1 injury, 39 malfunctions.

The most frequently reported specific device problem is “Collapse” (14 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 41 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 30, 2025Deformation Due to Compressive Stress; Deformation Due to Compressive Stress

  A PATIENT WAS IMPLANTED A CATHETER PLACEMENT PROCEDURE USING GLIDEPATH. ON (B)(6) 2023, THE PORT WAS IMPLANTED AND TWO YEARS, FOUR MONTHS AND THIRTEEN DAYS POST A DIALYSIS CATHETER PLACEMENT, THE CATHETER WAS ALLEGEDLY FOUND FLATTENED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23677457 ↗
• MalfunctionOct 7, 2024Collapse; Material Deformation; Collapse; Material Deformation

  IT WAS REPORTED THAT TWO MONTHS AND TWENTY-ONE DAYS POST A DIALYSIS CATHETER PLACEMENT, THE PLASTIC LUMEN ON THE CATHETER WAS ALLEGEDLY COLLAPSED. IT WAS FURTHER REPORTED THAT THE PLASTIC ALLEGEDLY WORE DOWN, SPECIFICALLY WHERE CLAMPS ARE EVEN WHEN ROTATED. REPORTEDLY, THE CATHETER WAS REPLACED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20392996 ↗
• MalfunctionOct 7, 2024Collapse; Material Deformation; Collapse; Material Deformation

  IT WAS REPORTED THAT TWO MONTHS AND TWENTY-ONE DAYS POST A DIALYSIS CATHETER PLACEMENT, THE PLASTIC LUMEN ON THE CATHETER WAS ALLEGEDLY COLLAPSED. IT WAS FURTHER REPORTED THAT THE PLASTIC ALLEGEDLY WORE DOWN, SPECIFICALLY WHERE CLAMPS ARE EVEN WHEN ROTATED. REPORTEDLY, THE CATHETER WAS REPLACED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20392969 ↗
• MalfunctionOct 7, 2024Collapse; Material Deformation; Collapse; Material Deformation

  IT WAS REPORTED THAT TWO MONTHS AND TWENTY-ONE DAYS POST A DIALYSIS CATHETER PLACEMENT, THE PLASTIC LUMEN ON THE CATHETER WAS ALLEGEDLY COLLAPSED. IT WAS FURTHER REPORTED THAT THE PLASTIC ALLEGEDLY WORE DOWN, SPECIFICALLY WHERE CLAMPS ARE EVEN WHEN ROTATED. REPORTEDLY, THE CATHETER WAS REPLACED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20392850 ↗
• MalfunctionOct 7, 2024Collapse; Material Deformation; Collapse; Material Deformation

  IT WAS REPORTED THAT TWO MONTHS AND TWENTY-ONE DAYS POST A DIALYSIS CATHETER PLACEMENT, THE PLASTIC LUMEN ON THE CATHETER WAS ALLEGEDLY COLLAPSED. IT WAS FURTHER REPORTED THAT THE PLASTIC ALLEGEDLY WORE DOWN, SPECIFICALLY WHERE CLAMPS ARE EVEN WHEN ROTATED. REPORTEDLY, THE CATHETER WAS REPLACED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20392840 ↗
• MalfunctionOct 7, 2024Collapse; Material Deformation; Collapse; Material Deformation

  IT WAS REPORTED THAT TWO MONTHS AND TWENTY-ONE DAYS POST A DIALYSIS CATHETER PLACEMENT, THE PLASTIC LUMEN ON THE CATHETER WAS ALLEGEDLY COLLAPSED. IT WAS FURTHER REPORTED THAT THE PLASTIC ALLEGEDLY WORE DOWN, SPECIFICALLY WHERE CLAMPS ARE EVEN WHEN ROTATED. REPORTEDLY, THE CATHETER WAS REPLACED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20392752 ↗
• MalfunctionOct 7, 2024Collapse; Material Deformation; Collapse; Material Deformation

  IT WAS REPORTED THAT TWO MONTHS AND TWENTY-ONE DAYS POST A DIALYSIS CATHETER PLACEMENT, THE PLASTIC LUMEN ON THE CATHETER WAS ALLEGEDLY COLLAPSED. IT WAS FURTHER REPORTED THAT THE PLASTIC ALLEGEDLY WORE DOWN, SPECIFICALLY WHERE CLAMPS ARE EVEN WHEN ROTATED. REPORTEDLY, THE CATHETER WAS REPLACED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20392730 ↗
• MalfunctionOct 7, 2024Collapse; Material Deformation; Collapse; Material Deformation

  IT WAS REPORTED THAT TWO MONTHS AND TWENTY-ONE DAYS POST A DIALYSIS CATHETER PLACEMENT, THE PLASTIC LUMEN ON THE CATHETER WAS ALLEGEDLY COLLAPSED. IT WAS FURTHER REPORTED THAT THE PLASTIC ALLEGEDLY WORE DOWN, SPECIFICALLY WHERE CLAMPS ARE EVEN WHEN ROTATED. REPORTEDLY, THE CATHETER WAS REPLACED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20392579 ↗
• MalfunctionOct 7, 2024Collapse; Material Deformation; Collapse; Material Deformation

  IT WAS REPORTED THAT TWO MONTHS AND TWENTY-ONE DAYS POST A DIALYSIS CATHETER PLACEMENT, THE PLASTIC LUMEN ON THE CATHETER WAS ALLEGEDLY COLLAPSED. IT WAS FURTHER REPORTED THAT THE PLASTIC ALLEGEDLY WORE DOWN, SPECIFICALLY WHERE CLAMPS ARE EVEN WHEN ROTATED. REPORTEDLY, THE CATHETER WAS REPLACED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20392444 ↗
• MalfunctionOct 7, 2024Collapse; Material Deformation; Collapse; Material Deformation

  IT WAS REPORTED THAT SIX MONTHS POST DIALYSIS CATHETER PLACEMENT, PLASTIC ON LUMEN ON THE DEVICE WAS ALLEGEDLY COLLAPSED. IT WAS FURTHER REPORTED THAT THE PLASTIC IS WEARING DOWN, SPECIFICALLY WHERE CLAMPS ARE EVEN WHEN ROTATED, REPORTEDLY, SOMETIMES UNSTABLE TO RUN. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20382020 ↗
• MalfunctionOct 7, 2024Collapse; Material Deformation; Collapse; Material Deformation

  IT WAS REPORTED THAT SIX MONTHS POST DIALYSIS CATHETER PLACEMENT, PLASTIC ON LUMEN ON THE DEVICE WAS ALLEGEDLY COLLAPSED. IT WAS FURTHER REPORTED THAT THE PLASTIC IS WEARING DOWN, SPECIFICALLY WHERE CLAMPS ARE EVEN WHEN ROTATED, REPORTEDLY, SOMETIMES UNSTABLE TO RUN. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20382017 ↗
• MalfunctionOct 7, 2024Collapse; Material Deformation; Collapse; Material Deformation

  IT WAS REPORTED THAT SIX MONTHS POST DIALYSIS CATHETER PLACEMENT, PLASTIC ON LUMEN ON THE DEVICE WAS ALLEGEDLY COLLAPSED. IT WAS FURTHER REPORTED THAT THE PLASTIC IS WEARING DOWN, SPECIFICALLY WHERE CLAMPS ARE EVEN WHEN ROTATED, REPORTEDLY, SOMETIMES UNSTABLE TO RUN. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20382016 ↗
• MalfunctionOct 7, 2024Collapse; Material Deformation; Collapse; Material Deformation

  IT WAS REPORTED THAT SIX MONTHS POST DIALYSIS CATHETER PLACEMENT, PLASTIC ON LUMEN ON THE DEVICE WAS ALLEGEDLY COLLAPSED. IT WAS FURTHER REPORTED THAT THE PLASTIC IS WEARING DOWN, SPECIFICALLY WHERE CLAMPS ARE EVEN WHEN ROTATED, REPORTEDLY, SOMETIMES UNSTABLE TO RUN. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20381969 ↗
• MalfunctionOct 7, 2024Collapse; Material Deformation; Collapse; Material Deformation

  IT WAS REPORTED THAT SIX MONTHS POST DIALYSIS CATHETER PLACEMENT, PLASTIC ON LUMEN ON THE DEVICE WAS ALLEGEDLY COLLAPSED. IT WAS FURTHER REPORTED THAT THE PLASTIC IS WEARING DOWN, SPECIFICALLY WHERE CLAMPS ARE EVEN WHEN ROTATED, REPORTEDLY, SOMETIMES UNSTABLE TO RUN. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20381732 ↗
• MalfunctionOct 7, 2024Collapse; Material Deformation; Collapse; Material Deformation

  IT WAS REPORTED THAT SIX MONTHS POST DIALYSIS CATHETER PLACEMENT, PLASTIC ON LUMEN ON THE DEVICE WAS ALLEGEDLY COLLAPSED. IT WAS FURTHER REPORTED THAT THE PLASTIC IS WEARING DOWN, SPECIFICALLY WHERE CLAMPS ARE EVEN WHEN ROTATED, REPORTEDLY, SOMETIMES UNSTABLE TO RUN. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20381730 ↗
• MalfunctionDec 9, 2023Fracture; Premature Separation; Fracture; Premature Separation

  IT WAS REPORTED THAT DURING PREPARATION OF A PORT PLACEMENT PROCEDURE, THE AIR GUARD VALVE WAS ALLEGEDLY CRACKED AND BEGINNING TO PEEL APART. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18298133 ↗
• MalfunctionOct 21, 2023Fracture; Fracture

  IT WAS REPORTED THAT THREE MONTHS AND TWENTY-SEVEN DAYS POST DIALYSIS CATHETER PLACEMENT, THE CATHETER ALLEGEDLY SPLIT IN THE ARTERIAL PORTION OF THE EXTERNAL LUMEN. REPORTEDLY, THE CATHETER WAS REPLACED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17982143 ↗
• InjuryFeb 13, 2023Obstruction of Flow; Expulsion; Obstruction of Flow; Expulsion

  IT WAS REPORTED THROUGH RESULTS OF A CLINICAL TRIAL THAT TWO MONTHS AND FOUR DAYS POST INDEX PROCEDURE, THE SUBJECT HAD SERIOUS ADVERSE EVENT OF CLOTTED CATHETER AND THE RELATIONSHIP TO STUDY DEVICE WAS POSSIBLY RELATED. IT WAS FURTHER REPORTED THAT, THE SUBJECT HAD SERIOUS ADVERSE EVENT OF EXPOSED CUFF CATHETER. THE RELATIONSHIP TO STUDY DEVICE WAS POSSIBLY RELATED AND ASSOCIATED WITH DEVICE FAILURE. REPORTEDLY, THE CATHETER WAS REMOVED AND THE REASON FOR REMOVAL WAS THROMBOSIS. THE PROCEDURE WAS COMPLETED BY EXCHANGING ANOTHER CATHETER. HOWEVER, THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 16362156 ↗
• MalfunctionNov 10, 2021Contamination /Decontamination Problem; Contamination /Decontamination Problem

  IT WAS REPORTED THAT DURING PREPARATION OF A PROCEDURE, THE FOREIGN PARTICLE WAS ALLEGEDLY FOUND IN THE DEVICE. THE PROCEDURE WAS COMPLETED BY USING ANOTHER DEVICE. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12784298 ↗
• MalfunctionMar 17, 2020Fracture; Fracture

  IT WAS REPORTED THAT DURING DIALYSIS CATHETER INSERTION, THE CATHETER TIP ALLEGEDLY BROKE OFF DURING THE TUNNELING PROCESS. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9845427 ↗
• MalfunctionMar 26, 2019Defective Component; Defective Component

  IT WAS REPORTED THAT DURING PREPARATION FOR CHRONIC CATHETER PLACEMENT, THE WHITE PLASTIC TUNNELER TIP ALLEGEDLY WAS CRACKED AND THE TIP BROKE OFF. ANOTHER DEVICE WAS USED TO COMPLETE PLACEMENT. THERE WAS NO REPORTED PATIENT CONTACT.

  Patient problems: No Patient Involvement

  MAUDE report 8452078 ↗
• MalfunctionMar 25, 2019Defective Component; Defective Component

  IT WAS REPORTED THAT DURING PREPARATION FOR CHRONIC CATHETER PLACEMENT, THE WHITE PLASTIC TUNNELER TIP ALLEGEDLY WAS CRACKED AND THE TIP BROKE OFF. ANOTHER DEVICE WAS USED TO COMPLETE PLACEMENT. THERE WAS NO REPORTED PATIENT CONTACT.

  Patient problems: No Patient Involvement

  MAUDE report 8450235 ↗
• MalfunctionMar 25, 2019Defective Component; Defective Component

  IT WAS REPORTED THAT DURING PREPARATION FOR CHRONIC CATHETER PLACEMENT, THE WHITE PLASTIC TUNNELER TIP ALLEGEDLY WAS CRACKED AND THE TIP BROKE OFF. ANOTHER DEVICE WAS USED TO COMPLETE PLACEMENT. THERE WAS NO REPORTED PATIENT CONTACT.

  Patient problems: No Patient Involvement

  MAUDE report 8450211 ↗
• MalfunctionMar 25, 2019Defective Component; Defective Component

  IT WAS REPORTED THAT DURING PREPARATION FOR CHRONIC CATHETER PLACEMENT, THE WHITE PLASTIC TUNNELER TIP ALLEGEDLY WAS CRACKED AND THE TIP BROKE OFF. ANOTHER DEVICE WAS USED TO COMPLETE PLACEMENT. THERE WAS NO REPORTED PATIENT CONTACT.

  Patient problems: No Patient Involvement

  MAUDE report 8450142 ↗
• MalfunctionFeb 26, 2019Defective Component; Defective Component

  IT WAS REPORTED THAT UPON OPENING THE CHRONIC CATHETER KIT, THE WHITE PLASTIC TUNNELER TIP WAS ALLEGEDLY CRACKED. THERE WAS NO REPORTED PATIENT CONTACT.

  Patient problems: No Patient Involvement

  MAUDE report 8372404 ↗