GlidePath Long-Term Hemodialysis Catheter with Preloaded Stylet 5393230Recalls & reported problems

Summary

The FDA's MAUDE database contains 138 adverse event reports that list this exact device (DI 00801741012181), received between Oct 20, 2016 and Jun 16, 2026 — classified as 5 deaths, 16 injuries, 117 malfunctions.

The most frequently reported specific device problem is “Defective Component” (36 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 138 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 16, 2026Fracture; Material Separation; Air/Gas in Device

  ON (B)(6) 2026, A PATIENT UNDERWENT A CONTINUOUS RENAL REPLACEMENT THERAPY (CRRT) USING A GLIDEPATH HEMODIALYSIS CATHETER. DURING THE PROCEDURE, AIR WAS OBSERVED THROUGHOUT THE MACHINE TUBING. VISUAL INSPECTION OF THE PERMACATH REVEALED A CLEAN AND COMPLETE STRUCTURAL BREAK AT THE DISTAL END OF ONE LUMEN, INDICATING A SEVERED CONNECTION POINT SEPARATE FROM THE LINE CAP. DUE TO THE RISK OF AIR EMBOLISM, THE PATIENT WAS IMMOBILIZED AND COULD NOT BE TURNED EVERY THREE HOURS, AS CONFIRMED BY THE PHYSICIAN. THE PRESENCE OF AIR IN THE CRRT CIRCUIT PRIOR TO CLAMPING POSED A POTENTIAL RISK OF VENOUS AIR EMBOLISM. AS PER MEDICAL TEAM INSTRUCTIONS, THE PATIENT IS UNDER STRICT MONITORING FOR ANY ACUTE NEUROLOGICAL CHANGES. THE DAMAGED PERMACATH REMAINS CLAMPED AND NON-FUNCTIONAL. THE FRACTURED COMPONENTS AND LINE SETUP WERE DOCUMENTED WITH PHOTOGRAPHS FOR FURTHER DEFECT INVESTIGATION. CRRT WAS DISCONTINUED AND COULD NOT BE RESUMED UNTIL PLACEMENT OF A NEW CATHETER. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25513967 ↗
• InjuryJun 5, 2026Fracture; Material Separation; Failure to Advance; Physical Resistance/Sticking

  On (b)(6), 2026, a 66-year-old patient underwent a catheter placement procedure through right internal jugular vein using the GlidePath Hemodialysis Catheter. During the procedure, the stiffener broke off inside the patient over the guidewire. It was further reported that, during insertion of the new Glidepath catheter and stiffener into the venous circulation, the device would not advance completely into the patient. Due to extreme resistance encountered during advancement, further advancement was stopped. The physician subsequently retrieved the broken stiffener fragment using a snare. The catheter and stiffener had only been advanced to the cavoatrial junction; therefore, it was presumed that the section of the wire distal to the atrium still contained the remaining stiffener. The patient is stable and no reported patient injury.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; No Clinical Signs, Symptoms or Conditions

  MAUDE report 25404066 ↗
• MalfunctionMay 6, 2026Fracture

  A PATIENT UNDERWENT A CATHETER PLACEMENT PROCEDURE USING GLIDEPATH HEMODIALYSIS. POST PROCEDURE ON (B)(6) 2026, IT WAS REPORTED THAT A SMALL CRACK WAS OBSERVED IN THE WHITE PLASTIC ADJACENT TO THE CATHETER HUB. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25090742 ↗
• MalfunctionMar 11, 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 24567192 ↗
• InjuryFeb 12, 2026Adverse Event Without Identified Device or Use Problem

  A PATIENT UNDERWENT A DIALYSIS CATHETER PLACEMENT PROCEDURE USING THE GLIDEPATH HEMODIALYSIS CATHETER. POST THE PROCEDURE, THE PATIENT ALLEGEDLY EXPERIENCED HEAT DURING MRI. THE CURRENT STATUS OF THE PATIENT WAS UNKNOWN.

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

  MAUDE report 24319974 ↗
• MalfunctionNov 28, 2025Expulsion; Loosening of Implant Not Related to Bone-Ingrowth; Expulsion; Loosening of Implant Not Related to Bone-Ingrowth

  A PATIENT UNDERWENT A HEMODIALYSIS CATHETER PLACEMENT PROCEDURE USING GLIDEPATH. DURING THE PROCEDURE, IT WAS REPORTED THAT MICROBUBBLES APPEARED IN CATHETER DURING DIALYSIS. IT WAS FURTHER REPORTED THAT THE CUFF WAS ALLEGEDLY DISLODGED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23670603 ↗
• InjuryNov 28, 2025Connection Problem; Air/Gas in Device; Connection Problem; Air/Gas in Device

  A PATIENT UNDERWENT A GLIDEPATH HEMODIALYSIS CATHETER PLACEMENT PROCEDURE. DURING THE PROCEDURE IT WAS REPORTEDTHAT THE CATHETER LUMEN WAS ALLEGEDLY FOUND LOOSE CONNECTION. IT WAS FURTHER REPORTED THAT PATIENT ALLEGEDLY EXPERIENCED MICROBUBBLES SEEN ON BLOODLINE. THE CURRENT STATUS OF THE PATIENT WAS UNKNOWN.

  Patient problems: Air Embolism

  MAUDE report 23670601 ↗
• InjuryNov 28, 2025Adverse Event Without Identified Device or Use Problem; Air/Gas in Device; Adverse Event Without Identified Device or Use Problem; Air/Gas in Device

  A PATIENT UNDERWENT FOR DIALYSIS CATHETER PLACEMENT PROCEDURE USING GLIDEPATH. POST THE CATHETER PLACEMENT PROCEDURE, THE PATIENT ALLEGEDLY EXPERIENCED MICROBUBBLES SEEN ON BLOODLINE. THE CURRENT STATUS OF THE PATIENT WAS UNKNOWN.

  Patient problems: Air Embolism

  MAUDE report 23669788 ↗
• InjuryNov 27, 2025Adverse Event Without Identified Device or Use Problem; Air/Gas in Device; Adverse Event Without Identified Device or Use Problem; Air/Gas in Device

  IT WAS REPORTED THAT POST GLIDEPATH HEMODIALYSIS CATHETER PLACEMENT, THE PATIENT ALLEGEDLY EXPERIENCED MICROBUBBLES SEEN ON BLOODLINE. THE CURRENT STATUS OF THE PATIENT WAS UNKNOWN.

  Patient problems: Air Embolism

  MAUDE report 23665248 ↗
• 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 23665241 ↗
• MalfunctionNov 27, 2025Expulsion; Loosening of Implant Not Related to Bone-Ingrowth; Expulsion; Loosening of Implant Not Related to Bone-Ingrowth

  A PATIENT UNDERWENT FOR A HEMODIALYSIS CATHETER PLACEMENT USING GLIDEPATH. 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 23665231 ↗
• MalfunctionNov 27, 2025Expulsion; Loosening of Implant Not Related to Bone-Ingrowth; Expulsion; Loosening of Implant Not Related to Bone-Ingrowth

  ON (B)(6) 2025, A PATIENT UNDERWENT FOR A HEMODIALYSIS CATHETER PLACEMENT USING GLIDEPATH. 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 23665230 ↗
• MalfunctionOct 8, 2025Complete Blockage; Coagulation in Device or Device Ingredient; Entrapment of Device; Nonstandard Device; Defective Component; Failure to Advance; Complete Blockage; Coagulation in Device or Device Ingredient; Entrapment of Device; Nonstandard Device; Defective Component; Failure to Advance

  ON (B)(6) 2025, A PATIENT UNDERWENT A PLACEMENT PROCEDURE OF GLIDEPATH DIALYSIS CATHETER VIA RIGHT INTERNAL JUGULAR VEIN. DURING THE PROCEDURE, IT WAS REPORTED THAT THE DILATOR WAS ALLEGEDLY DID NOT HAVE A HOLLOW SPACE FOR THE GUIDEWIRE TO PASS THROUGH. IT WAS FURTHER REPORTED THAT THE DILATOR WAS STUCK INSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED BY USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23243023 ↗
• DeathAug 28, 2025Disconnection; Fluid/Blood Leak; Disconnection; Fluid/Blood Leak

  ON (B)(6) 2025, A PATIENT UNDERWENT A BD GLIDEPATH DIALYSIS CATHETER PLACEMENT PROCEDURE FOR DIALYSIS TREATMENT. ON (B)(6) 2025, IT WAS REPORTED DURING A DIALYSIS SESSION, THE VENOUS-SIDE LUER CONNECTOR ALLEGEDLY DETACHED FROM THE DIALYSIS CIRCUIT WHILE THE CIRCUIT WAS BEING ROTATED, RESULTING IN A SIGNIFICANT BLOOD LOSS. REPORTEDLY, THERE WAS NO VISIBLE DAMAGE TO THE VENOUS SIDE LUER CONNECTOR. THE INCIDENT WAS DISCOVERED DURING A STAFF LUNCH CHANGEOVER, AND THE PATIENT SUBSEQUENTLY PASSED AWAY. THE HOSPITAL BELIEVES THE DISCONNECTION MAY HAVE BEEN DUE TO AN INSECURE CONNECTION, LIKELY A PROCEDURAL ISSUE. THE PATIENT'S CAUSE OF DEATH WAS UNKNOWN.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 22910677 ↗
• MalfunctionAug 19, 2025Deformation Due to Compressive Stress; Deformation Due to Compressive Stress

  ON (B)(6) 2025, A PATIENT UNDERWENT A DIALYSIS CATHETER PLACEMENT PROCEDURE USING GLIDEPATH. IT WAS REPORTED THAT DURING A PLACEMENT PROCEDURE, THE CVC LINE WAS ALLEGEDLY DEFORMED AND FLATTENED FROM THE CVC HUB. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22837691 ↗
• MalfunctionJun 18, 2025Contamination; Nonstandard Device; Device Contamination with Chemical or Other Material; Device Contaminated During Manufacture or Shipping; Contamination; Nonstandard Device; Device Contamination with Chemical or Other Material; Device Contaminated During Manufacture or Shipping

  ON (B)(6) 2025, A PATIENT WAS PREPPED FOR A DIALYSIS CATHETER PLACEMENT PROCEDURE USING GLIDEPATH. PRIOR TO USE OF THE DEVICE ON PATIENT, IT WAS NOTED THAT SOME LUBRICANT TYPE SUBSTANCE APPEARED ON THE RED END OF THE DEVICE. THERE WAS NO REPORTED PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22268486 ↗
• MalfunctionMay 2, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2025, CVC BLEEDING AT EXIT SITE WAS NOTED POST DIALYSIS CATHETER PLACEMENT.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 21948765 ↗
• MalfunctionMay 2, 2025Reflux within Device; Reflux within Device

  ON (B)(6) 2025 CVC LIMBS ARE LOCKED EVERY TIME AFTER ACCESSING, PATIENT RETURNED FOR HEMO AND BOTH LIMBS HAD BLOOD BACKED UP TO THE CLAMPS, BLOOD NOTED TO DRESSING AT INSERTION SITE POST DIALYSIS CATHETER PLACEMENT.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 21948760 ↗
• InjuryMay 2, 2025Reflux within Device; Reflux within Device

  ON (B)(6) 2025 ¿ PATIENT RETURNED FOR HEMODIALYSIS AND BOTH LIMBS HAD BLOOD BACKED UP TO THE CLAMPS, WHEN NURSE WENT TO ASPIRATE THE LIMBS, CLOTS WERE REMOVED FROM BOTH LIMBS. THIS ONLY HAPPENED ONCE, NO FURTHER CLOTTING.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Thrombosis/Thrombus

  MAUDE report 21948754 ↗
• MalfunctionMay 2, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2025, PURSE STRING SUTURE REMOVED (PLACED DUE TO BLEEDING AT INSERTION SITE WHEN CVC INITIALLY INSERTED), JUGULAR SUTURE REMOVED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 21948465 ↗
• MalfunctionMay 2, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2025, BLEEDING TO EXIT SITE WAS NOTED POST DIALYSIS CATHETER PLACEMENT.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 21948461 ↗
• MalfunctionApr 23, 2025Reflux within Device; Reflux within Device

  IT WAS REPORTED THAT THREE MONTHS POST DIALYSIS CATHETER PLACEMENT, BOTH OR ONE LIMB ALLEGEDLY HAD BLOOD BACKED UP ALL THE WAY TO THE CLAMP. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21888449 ↗
• MalfunctionApr 11, 2025Deformation Due to Compressive Stress; Deformation Due to Compressive Stress

  IT WAS REPORTED THAT DURING A DIALYSIS CATHETER PLACEMENT PROCEDURE VIA RIGHT INTERNAL JUGULAR VEIN, THE CATHETER WAS ALLEGEDLY KINKED. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVCE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21824710 ↗
• MalfunctionMar 13, 2025Difficult to Remove; Stretched; Improper or Incorrect Procedure or Method; Deformation Due to Compressive Stress; Physical Resistance/Sticking; Difficult to Remove; Stretched; Improper or Incorrect Procedure or Method; Deformation Due to Compressive Stress; Physical Resistance/Sticking

  IT WAS REPORTED THAT DURING A PORT PLACEMENT PROCEDURE THE TIP OF THE GUIDEWIRE ALLEGEDLY WAS STUCK AND WOULD NOT COME OUT. IT WAS FURTHER REPORTED THAT THERE WAS STRETCHING IN THE NEEDLE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21592428 ↗
• DeathFeb 14, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT DURING A SCHEDULED HEMODIALYSIS TREATMENT THROUGH THE HEMODIALYSIS CENTRAL VENOUS CATHETER, THE NURSE IDENTIFIED A POOL OF BLOOD OF APPROXIMATELY 100-300ML UNDER THE PATIENT'S CHAIR DURING THE FIRST SEVERAL MINUTES OF TREATMENT INITIATION. IT WAS FURTHER REPORTED THAT THE BLOOD PUMP WAS STOPPED, AND IT WAS DISCOVERED THAT THE BLOOD LOSS WAS ORIGINATING FROM THE VENOUS BLOODLINE/VENOUS LUMEN CONNECTION SITE. REPORTEDLY, THE PATIENT'S CAROTID PULSE WAS PALPABLE, HEMODIALYSIS TREATMENT WAS TERMINATED, AND BLOOD WAS RETURNED USING ARTERIAL LUMEN OF THE CATHETER. THE PATIENT BECAME UNRESPONSIVE, THE EMERGENCY RESPONSE SERVICES WAS CALLED, AND CPR WAS INITIATED. UPON ARRIVAL, THE EMERGENCY RESPONSE SERVICES CONTINUED RESUSCITATIVE EFFORTS WHILE TRANSPORTING THE PATIENT TO THE HOSPITAL. THE PATIENT REPORTEDLY EXPIRED SHORTLY AFTER.

  Patient problems: Cardiac Arrest; Exsanguination

  MAUDE report 21382474 ↗