HemoSplit Long-Term Hemodialysis Catheter 5733270Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 00801741013010), received between Oct 30, 2015 and Aug 5, 2026 — classified as 1 death, 3 injuries, 10 malfunctions.

The most frequently reported specific device problem is “Fracture” (6 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 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• InjuryAug 5, 2026Improper or Incorrect Procedure or Method

  It has been reported that the patient underwent placement of a HemoSplit Hemodialysis Catheter on (b)(6)2026, at (b)(6). Following insertion, it was determined that the right sided dialysis catheter had been inadvertently inserted through both walls of the internal jugular vein into the mediastinum. The patient was transferred to (b)(6) ) for further management and catheter removal. On (b)(6) 2026, the patient was admitted to the Cardiothoracic Critical Care Unit (CTCCU). The misplaced catheter was removed in a hybrid theatre/angiography suite using guidewire-assisted removal with balloon tamponade. The removal procedure was uneventful, and a new left-sided dialysis catheter was subsequently inserted. Following intubation for the catheter removal procedure, the patient developed type II respiratory failure and required prolonged mechanical ventilation in CTCCU. After extubation, the patient experienced new-onset expressive dysphasia and left upper limb weakness, requiring re-intubation. A CT scan performed on (b)(6) 2026, demonstrated pre-existing cerebral infarcts and no evidence of intracranial hemorrhage. The patient was transferred back to (b)(6) on (b)(6) 2026 and remained ven

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Dysphasia; Respiratory Failure

  MAUDE report 50137649 ↗
• MalfunctionJan 13, 2026Fracture

  ON (B)(6) 2025, A PATIENT WITH KIDNEY DISEASE REQUIRING LONG-TERM HEMODIALYSIS UNDERWENT IMPLANTATION OF A SEMI-IMPLANTABLE CATHETER TO PROVIDE VASCULAR ACCESS FOR THERAPY. DURING THE PROCEDURE, THE INTRODUCER OF THE FIRST CATHETER KIT FRACTURED WHILE BEING INSERTED, MAKING IT IMPOSSIBLE TO CONTINUE USING THE DEVICE. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24050487 ↗
• MalfunctionJan 30, 2024Restricted Flow rate; Deformation Due to Compressive Stress; Material Integrity Problem; Restricted Flow rate; Deformation Due to Compressive Stress; Material Integrity Problem

  IT WAS REPORTED THAT SOMETIME POST DIALYSIS CATHETER PLACEMENT, THE CATHETERS REPEATEDLY EXHIBITED VENOUS AND ARTERIAL CLAMPING DAMAGE ON BOTH LEGS, WHICH ALLEGEDLY LED TO FLOW LIMITATIONS. IT WAS FURTHER REPORTED THAT THE TUBE WAS ALLEGEDLY NARROWED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18608001 ↗
• MalfunctionJan 5, 2024Entrapment of Device; Fracture; Material Separation; Entrapment of Device; Fracture; Material Separation

  IT WAS REPORTED THAT DURING A DIALYSIS CATHETER PLACEMENT PROCEDURE, THE DILATOR ALLEGEDLY CAME OFF FROM THE SHEATH OF THE TUNNELER AND ALLEGEDLY GOT STUCK IN SUBCUTANEOUS FAT OF THE PATIENT. IT WAS FURTHER REPORTED THAT A PART OF THE SHEATH ALLEGEDLY BROKE OFF. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18451891 ↗
• MalfunctionOct 11, 2023Melted; Moisture Damage; Unsealed Device Packaging; Melted; Moisture Damage; Unsealed Device Packaging

  IT WAS REPORTED THAT PRIOR TO A DIALYSIS CATHETER PLACEMENT PROCEDURE, THE PACKAGING WAS ALLEGEDLY DAMAGED. IT WAS FURTHER REPORTED THAT THE INNER SEAL WAS VISIBLY OPENED BUT THE CONTENTS WERE INTACT. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17911661 ↗
• MalfunctionOct 11, 2023Moisture Damage; Unsealed Device Packaging; Moisture Damage; Unsealed Device Packaging

  IT WAS REPORTED THAT PRIOR TO A DIALYSIS CATHETER PLACEMENT PROCEDURE, THE PACKAGING WAS ALLEGEDLY DAMAGED. IT WAS FURTHER REPORTED THAT THE INNER SEAL WAS VISIBLY OPENED BUT THE CONTENTS WERE INTACT. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17911564 ↗
• MalfunctionOct 11, 2023Unsealed Device Packaging; Unsealed Device Packaging

  IT WAS REPORTED THAT PRIOR TO A DIALYSIS CATHETER PLACEMENT PROCEDURE, THE PACKAGING WAS ALLEGEDLY DAMAGED. IT WAS FURTHER REPORTED THAT THE INNER SEAL WAS VISIBLY OPENED BUT THE CONTENTS WERE INTACT. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17911562 ↗
• DeathDec 20, 2022Fluid/Blood Leak; Fracture; Material Separation; Material Split, Cut or Torn; Fluid/Blood Leak; Fracture; Material Separation; Material Split, Cut or Torn

  IT WAS REPORTED THAT LOCAL POLICE/AUTHORITIES IN GERMANY ARE INVESTIGATING A DEATH EVENT OF A SUBJECT WHO HAD A DIALYSIS CATHETER IMPLANTED AND THE CATHETER WAS ALLEGEDLY "TORN OFF" EXTRACORPOREALLY. THE AUTHORITIES DID NOT MENTION ANY PRODUCT RECLAMATION AND REPORTEDLY DO NOT KNOW IF THE DEATH WAS A RESULT OF SUICIDE, USER MISTAKE, OR DUE TO A CATHETER FAILURE.

  Patient problems: Insufficient Information

  MAUDE report 16012799 ↗
• InjuryMay 4, 2021Suction Problem; Material Deformation; Suction Problem; Material Deformation

  IT WAS REPORTED THAT SOME TIME POST CATHETER PLACEMENT, THE CATHETER ALLEGEDLY KINKED DURING USAGE. THERE WAS NO REPORTED PATIENT INJURY.

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

  MAUDE report 11769384 ↗
• InjuryMay 4, 2021Fracture; Material Separation; Deformation Due to Compressive Stress; Detachment of Device or Device Component; Fracture; Material Separation; Deformation Due to Compressive Stress; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING DIALYSIS CATHETER PLACEMENT PROCEDURE, THE PLASTIC SLEEVE OF THE INTRODUCER ALLEGEDLY TORN OFF. IT WAS FURTHER REPORTED THAT THE STUCKED BROKEN PART WAS ALLEGEDLY REMOVED VIA A SECOND INCISION. THE PATIENT CURRENT STATUS WAS UNKNOWN.

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

  MAUDE report 11769311 ↗
• MalfunctionFeb 11, 2021Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED DURING DIALYSIS CATHETER PLACEMENT PROCEDURE, THE EXTENSION LEGS OF THE DEVICE WERE IMPROPERLY COLORED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11312598 ↗
• MalfunctionJul 8, 2019Defective Component; Defective Component

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

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8769036 ↗
• MalfunctionNov 3, 2015Fracture

  ALLEGEDLY, 27 CM CATHETER WAS PLACED. AGAIN, THIS REPLACED HEMOSPLIT 27CM GOT FRACTURED WITH IN A WEEK IN THE PLACE OF CLAMP IN BOTH THE LUERS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 5199442 ↗
• MalfunctionOct 30, 2015Fracture

  ALLEGEDLY, CATHETER GOT FRACTURED IN THE PLACE OF CLAMPING, REPORTEDLY WITHIN 5 DAYS OF INSERTION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 5193139 ↗