GlidePath Long-Term Hemodialysis Catheter with Preloaded Stylet 5397190Recalls & reported problems

Summary

The FDA's MAUDE database contains 26 adverse event reports that list this exact device (DI 00801741012297), received between Apr 22, 2019 and Mar 6, 2026 — classified as 4 injuries, 22 malfunctions.

The most frequently reported specific device problem is “Defective Component” (15 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 26 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 6, 2026Fracture; Material Separation

  ON (B)(6) 2026, A PATIENT PREPPED FOR A DIALYSIS CATHETER PLACEMENT PROCEDURE USING THE GLIDEPATH HEMODIALYSIS CATHETER. PRIOR TO THE PROCEDURE, THE CATHETER WAS ALLEGEDLY BROKEN. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24528317 ↗
• MalfunctionAug 13, 2025Collapse; Deformation Due to Compressive Stress; Material Deformation; Collapse; Deformation Due to Compressive Stress; Material Deformation

  ON (B)(6) 2025, A PATIENT UNDERWENT FOR A CATHETER PLACEMENT PROCEDURE USING GLIDEPATH. DURING THE CATHETER PLACEMENT PROCEDURE, HEMODIALYSIS CATHETER LUMENS WERE OBSERVED TO COMPRESS AND COLLAPSE AT THE CLAMP SITE PRIOR TO DIALYSIS AND DURING DIALYSIS TREATMENT. DESPITE REPOSITIONING THE CLAMP, MEMORY CREASES PERSISTED, INDICATING A POTENTIAL MATERIAL OR MANUFACTURING DEFECT. THE MALFUNCTION LED TO DELAYS IN DIALYSIS TREATMENT AND INADEQUATE THERAPY DELIVERY. THERE IS A POTENTIAL RISK OF HEMOLYSIS DUE TO KINKS IN THE CATHETER, WHICH COULD RESULT IN MILD TEMPORARY HARM TO THE PATIENT. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22798082 ↗
• MalfunctionApr 22, 2025Decrease in Suction; Suction Problem; Deformation Due to Compressive Stress; Decrease in Suction; Suction Problem; Deformation Due to Compressive Stress

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21882326 ↗
• MalfunctionFeb 26, 2025Contamination; Packaging Problem; Contamination; Packaging Problem

  IT WAS REPORTED THAT PRIOR TO A DIALYSIS CATHETER PLACEMENT PROCEDURE, THE DEVICE ALLEGEDLY FOUND AN ORANGE STAIN. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21466737 ↗
• MalfunctionJul 15, 2024Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT DURING A DIALYSIS CATHETER PLACEMENT PROCEDURE, THOUGH THE CATHETER CUFF WAS DEEPER, A HALF A CENTIMETER INCISION WAS MADE AT THE CUFF SITE AND WITH BLUNT DISSECTION THE CUFF OF THE CATHETER WAS FREED. IT WAS FURTHER REPORTED THAT WHEN THE CATHETER WAS CLAMPED, IT ALLEGEDLY BECAME SEVERED AT THE CUFF. REPORTEDLY, THE PROXIMAL SEGMENT WAS CLAMPED, AND WIRE WAS INTRODUCED, AND THE CATHETER WAS REMOVED OVER THE GUIDEWIRE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19747243 ↗
• MalfunctionJan 28, 2024Material Discolored; Material Opacification; Stretched; Material Discolored; Material Opacification; Stretched

  IT WAS REPORTED THAT SOMETIME POST PORT DIALYSIS CATHETER PLACEMENT PROCEDURE, THE CATHETER WAS ALLEGEDLY DISCOLORED. IT WAS FURTHER REPORTED THAT SOME PARTS OF THE CATHETER ALLEGEDLY APPEARED OPAQUE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18593032 ↗
• InjuryJan 3, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THROUGH THE RESULTS OF A CLINICAL THAT FIVE MONTHS AND SIX DAYS POST INDEX PROCEDURE COMPLETION, THE SUBJECT DEVELOPED AN ADVERSE EVENT OF PREMATURE REMOVAL OF TUNNELED CENTRAL CATHETER DUE TO SUSPECTED BACTEREMIA. IT WAS FURTHER REPORTED THAT THE PATIENT WAS PROVIDED WITH ANTIBIOTICS FOR TREATMENT. REPORTEDLY, THE CATHETER WAS REMOVED. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Bacteremia

  MAUDE report 18433380 ↗
• InjuryFeb 28, 2023Obstruction of Flow; Obstruction of Flow

  IT WAS REPORTED THROUGH RESULTS OF A CLINICAL TRIAL THAT TWO DAYS POST INDEX PROCEDURE, THE SUBJECT EXPERIENCED AN ADVERSE EVENT OF A CLOTTED CATHETER. IT WAS FURTHER REPORTED THAT THE ADVERSE EVENT WAS DETERMINED TO BE ASSOCIATED WITH DEVICE FAILURE AND POSSIBLY RELATED TO STUDY DEVICE. REPORTEDLY, THE CATHETER WAS REMOVED DUE TO THROMBOSIS. THE PROCEDURE WAS COMPLETED BY EXCHANGING ANOTHER CATHETER. HOWEVER, THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 16451881 ↗
• InjuryFeb 13, 2023Obstruction of Flow; Obstruction of Flow

  IT WAS REPORTED THROUGH RESULTS OF A CLINICAL TRIAL THAT THREE MONTHS AND EIGHTEEN DAYS POST INDEX PROCEDURE, THE SUBJECT HAD AN ADVERSE EVENT OF CLOTTED CATHETER. IT WAS FURTHER REPORTED THAT, THE ADVERSE EVENT 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 16362157 ↗
• InjuryFeb 13, 2023Obstruction of Flow; Obstruction of Flow

  IT WAS REPORTED THROUGH RESULTS OF A CLINICAL TRIAL THAT EIGHT MONTHS AND SIX DAYS POST INDEX PROCEDURE, THE SUBJECT HAD AN ADVERSE EVENT OF CLOTTED CATHETER AND RELATIONSHIP TO STUDY DEVICE WAS POSSIBLY RELATED. IT WAS FURTHER REPORTED THAT, EIGHT MONTHS AND TEN DAYS POST INDEX PROCEDURE, THE ADVERSE EVENT WAS 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 16362155 ↗
• MalfunctionJun 13, 2019Defective Component; Defective Component

  IT WAS REPORTED THAT DURING THE PLACEMENT OF THE DIALYSIS CATHETER, THE TUNNELER ALLEGEDLY BROKE IN THE CATHETER. REPORTEDLY, THE BROKEN PIECE OF THE TUNNELER WAS REMOVED, HOWEVER, SAME CATHETER WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8698166 ↗
• MalfunctionJun 6, 2019Defective Component; Defective Component

  IT WAS REPORTED THAT THE PLASTIC STEM ON THE TUNNELER ALLEGEDLY BROKE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8675385 ↗
• MalfunctionMay 28, 2019Component Missing; Component Missing

  IT WAS REPORTED THAT THE PEEL-AWAY SHEATH WAS ALLEGEDLY MISSING FROM THE PRODUCT PACKAGE. THEREFORE, ANOTHER KIT WAS OPENED AND USED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Patient Involvement

  MAUDE report 8648155 ↗
• MalfunctionMay 28, 2019Defective Component; Defective Component

  IT WAS REPORTED THAT PRIOR TO THE TUNNELED DIALYSIS CATHETER PROCEDURE, A BROKEN TUNNELER WAS ALLEGEDLY NOTICED WHEN IT WAS TAKEN OUT OF PACKAGE. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Patient Involvement

  MAUDE report 8647997 ↗
• MalfunctionMay 23, 2019Defective Component; Defective Component

  IT WAS REPORTED THAT DURING THE TUNNELING PROCESS, THE PLASTIC STEM ON THE TUNNELER COMPONENT OF A DIALYSIS CATHETER ALLEGEDLY BROKE AND REMAINED IN THE CATHETER. IT WAS FURTHER REPORTED THAT BOTH, TUNNELER COMPONENT AND CATHETER WERE REMOVED AND NOT USED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8636346 ↗
• MalfunctionMay 22, 2019Defective Component; Defective Component

  IT WAS REPORTED THAT THE TUNNELER TIP ALLEGEDLY BROKE DURING THE PROCEDURE. IT WAS FURTHER REPORTED THAT A SECOND DEVICE WAS OPENED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8633670 ↗
• MalfunctionMay 22, 2019Defective Component; Defective Component

  IT WAS REPORTED THAT THE TUNNELER TIP ALLEGEDLY BROKE DURING THE PROCEDURE. IT WAS FURTHER REPORTED THAT A SECOND DEVICE WAS OPENED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8633284 ↗
• MalfunctionMay 20, 2019Defective Component; Defective Component

  IT WAS REPORTED THAT THE TUNNELER ALLEGEDLY BROKE INSIDE THE CATHETER DURING PLACEMENT AND THE BROKEN PIECES WERE RETRIEVED. REPORTEDLY, A NEW KIT WAS OPENED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8624821 ↗
• MalfunctionMay 17, 2019Defective Component; Defective Component

  IT WAS REPORTED THAT A TUNNELER ALLEGEDLY BROKE DURING DIALYSIS CATHETER PLACEMENT. PATIENT STATUS IS UNKNOWN.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8620695 ↗
• MalfunctionMay 16, 2019Defective Component; Defective Component

  IT WAS REPORTED THAT THE TUNNELER ALLEGEDLY BROKE DURING PLACEMENT DIALYSIS CATHETER PLACEMENT. IT WAS FURTHER REPORTED THAT ANOTHER DEVICE WAS OPENED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8616583 ↗
• MalfunctionMay 16, 2019Defective Component; Defective Component

  IT WAS REPORTED THAT THE TUNNELER COMPONENT THAT ATTACHES TO THE DIALYSIS CATHETER ALLEGEDLY BROKE. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Patient Involvement

  MAUDE report 8616211 ↗
• MalfunctionMay 8, 2019Defective Component; Defective Component

  IT WAS REPORTED THAT THE TIP OF THE TUNNELER ALLEGEDLY BROKE OFF INSIDE THE CATHETER. TIP OF THE TUNNELER AND THE CATHETER WAS REMOVED SUCCESSFULLY FROM THE PATIENT. REPORTEDLY, NEW DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8593453 ↗
• MalfunctionMay 8, 2019Defective Component; Defective Component

  IT WAS REPORTED THAT DURING PREPARATION OF THE INSERTION PROCEDURE WHILE ATTEMPTING TO ATTACH THE TUNNELER COMPONENT TO THE DIALYSIS CATHETER, THE PLASTIC PIECE ON THE TUNNELER BROKE OFF. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Patient Involvement

  MAUDE report 8592477 ↗
• MalfunctionMay 8, 2019Defective Component; Defective Component

  IT WAS REPORTED THAT DURING PREPARATION OF THE INSERTION PROCEDURE WHILE ATTEMPTING TO ATTACH THE TUNNELER COMPONENT TO THE DIALYSIS CATHETER, THE PLASTIC PIECE ON THE TUNNELER BROKE OFF. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Patient Involvement

  MAUDE report 8592293 ↗
• MalfunctionApr 22, 2019Defective Component; Defective Component

  IT WAS REPORTED THAT PRIOR TO PLACING THE DIALYSIS CATHETER, THE TUNNELER ALLEGEDLY BROKE. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED PATIENT CONTACT.

  Patient problems: No Patient Involvement

  MAUDE report 8537773 ↗