HemoStar Long-Term Hemodialysis Catheter 5833350Recalls & reported problems

Summary

The FDA's MAUDE database contains 21 adverse event reports that list this exact device (DI 00801741013362), received between Apr 4, 2018 and Apr 30, 2025 — classified as 21 malfunctions.

The most frequently reported specific device problem is “Fracture” (9 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 21 most recent of 21 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 30, 2025Device Markings/Labelling Problem; Device Markings/Labelling Problem

  ON (B)(6) 2025, A PATIENT WAS UNDERGOING A DIALYSIS CATHETER PLACEMENT PROCEDURE. IT WAS REPORTED THAT THE CATHETER PACKAGING DID NOT HAVE ANY LABEL STICKERS SHOWING THE LOT NUMBER OR THE EXPIRATION DATE OF THE PRODUCT. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21932679 ↗
• MalfunctionDec 28, 2023Difficult to Remove; Failure to Advance; Deformation Due to Compressive Stress; Physical Resistance/Sticking; Difficult to Remove; Failure to Advance; Deformation Due to Compressive Stress; Physical Resistance/Sticking

  IT WAS REPORTED THAT DURING A DIALYSIS CATHETER PLACEMENT PROCEDURE, THE CATHETER ALLEGEDLY CANNOT BE PASSED INTO THE GUIDEWIRE. IT WAS FURTHER REPORTED THAT THE GUIDEWIRE ALLEGEDLY STUCK ON THE PUNCTURE NEEDLE AND ALLEGEDLY COULD NOT BE REMOVED. IT WAS FURTHER REPORTED THAT THE GUIDEWIRE WAS ALLEGEDLY BENT. REPORTEDLY, THE PATIENT EXPERIENCED ALLEGEDLY BLEEDING AND LOCAL COMPRESSION WAS DONE TO STOP THE BLEEDING. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18408201 ↗
• MalfunctionOct 11, 2023Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT SOMETIME POST A DIALYSIS CATHETER PLACEMENT, THE CATHETER TANK BODY WAS ALLEGEDLY DAMAGED. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17911109 ↗
• MalfunctionOct 10, 2023Fracture; Fracture

  IT WAS REPORTED THAT SOMETIME POST A DIALYSIS CATHETER PLACEMENT, THE CLAMP WAS ALLEGEDLY BROKEN. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17903566 ↗
• MalfunctionSep 20, 2023Fracture; Fracture

  IT WAS REPORTED THAT SOMETIME POST DIALYSIS CATHETER PLACEMENT, THE CLAMP WAS ALLEGEDLY BROKEN. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17778510 ↗
• MalfunctionJun 28, 2023Fracture; Air/Gas in Device; Fracture; Air/Gas in Device

  IT WAS REPORTED THAT DURING A PORT PLACEMENT PROCEDURE, INTRODUCER NEEDLE ALLEGEDLY RUPTURED. IT WAS FURTHER REPORTED THAT INTRODUCER NEEDLE ALLEGEDLY LEAKED AIR. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17215765 ↗
• MalfunctionJun 27, 2023Fluid/Blood Leak; Fracture; Air/Gas in Device; Fluid/Blood Leak; Fracture; Air/Gas in Device

  IT WAS REPORTED THAT DURING A DIALYSIS CATHETER PLACEMENT PROCEDURE, THE INTRODUCER NEEDLE WAS ALLEGEDLY RUPTURED. IT WAS FURTHER REPORTED THAT THE INTRODUCER NEEDLE ALLEGEDLY LEAKED AIR. FURTHERMORE, SALINE ALLEGEDLY LEAKED IN THE PINK JOINT OF THE INTRODUCER NEEDLE WHEN INJECTED. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17206738 ↗
• MalfunctionMay 24, 2023Detachment of Device or Device Component; Material Deformation; Detachment of Device or Device Component; Material Deformation

  IT WAS REPORTED THAT DURING THE PREPARATION OF DIALYSIS CATHETER PLACEMENT PROCEDURE, UPON UNPACKING OF THE CATHETER, A PROBLEM WAS ALLEGEDLY FOUND WITH THE SHEATH WHICH HAD UNEVEN RUBBER. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16990442 ↗
• MalfunctionApr 15, 2022Material Opacification; Stretched; Material Protrusion/Extrusion; Material Opacification; Stretched; Material Protrusion/Extrusion

  IT WAS REPORTED THAT APPROXIMATELY ONE YEAR POST CATHETER PLACEMENT, THE DEVICE ALLEGEDLY HAD WHITE OPACIFICATION OF THE TRANSPARENT PART. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14119525 ↗
• MalfunctionOct 26, 2020Fracture; Fracture

  IT WAS REPORTED THAT DURING A CATHETER PLACEMENT, THE NEEDLE WAS ALLEGEDLY FRACTURED AND PUNCTURE FAILURE. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10734439 ↗
• MalfunctionSep 8, 2020Fracture; Suction Problem; Fracture; Suction Problem

  IT WAS REPORTED THAT DURING A CATHETER PLACEMENT, THE PLASTIC CONNECTOR OF INTRODUCER NEEDLE WAS BROKEN. 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 10500622 ↗
• MalfunctionSep 1, 2020Fracture; Fracture

  IT WAS REPORTED THAT DURING IMPLANTATION PROCEDURE, THE PLASTIC FITTING OF THE INTRODUCER NEEDLE WAS ALLEGEDLY BROKEN. REPORTEDLY THE ALLEGED ISSUE LEADS TO AIR LEAKS DURING ASPIRATION. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10475984 ↗
• MalfunctionApr 16, 2020Fracture; Fracture

  IT WAS REPORTED THAT PRIOR TO A HEMODIALYSIS PROCEDURE, INTRODUCTION NEEDLE OF THE DIALYSIS CATHETER WAS ALLEGEDLY FOUND TO BE FRACTURED. REPORTEDLY, THE INTRODUCTION NEEDLE WAS REPLACED AND THE PROCEDURE WAS COMPLETED. THERE WAS NO REPORTED PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 9970108 ↗
• MalfunctionFeb 5, 2020Device Damaged Prior to Receipt by User; Tear, Rip or Hole in Device Packaging; Device Damaged Prior to Receipt by User; Tear, Rip or Hole in Device Packaging

  IT WAS REPORTED THAT UPON OPENING THE DIALYSIS CATHETER PACKAGE, THE PACKAGE WAS ALLEGEDLY TORN. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Patient Involvement

  MAUDE report 9671250 ↗
• MalfunctionOct 8, 2019Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THE INTRODUCER NEEDLE ALLEGEDLY LEAKED AIR. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9166497 ↗
• MalfunctionOct 8, 2019Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging

  IT WAS REPORTED THAT THE DIALYSIS KIT PACKAGING BAG WAS ALLEGEDLY DAMAGED. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Patient Involvement

  MAUDE report 9166491 ↗
• MalfunctionOct 1, 2019Fluid/Blood Leak; Fracture; Fluid/Blood Leak; Fracture

  IT WAS REPORTED THAT DURING A DIALYSIS CATHETER PLACEMENT THE INTRODUCER NEEDLE WAS INSERTED UNDER ULTRASOUND GUIDANCE AND ALLEGEDLY FLUID WAS LEAKING FROM THE HUB DURING ASPIRATION. REPORTEDLY, IT WAS IDENTIFIED THAT THE HUB ALLEGEDLY RUPTURED. 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 9142052 ↗
• MalfunctionAug 22, 2019Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT UPON OPENING THE DIALYSIS CATHETER PACKAGE, FOREIGN MATERIAL WAS ALLEGEDLY PRESENT AND THE CATHETER WAS NOT USED. REPORTEDLY, ANOTHER CATHETER WAS OPENED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Patient Involvement

  MAUDE report 8923246 ↗
• MalfunctionMay 6, 2019Component Missing; Component Missing

  IT WAS REPORTED THAT THE GUIDEWIRE WAS ALLEGEDLY MISSING. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Patient Involvement

  MAUDE report 8582774 ↗
• MalfunctionSep 12, 2018Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE CATHETER DISCONNECTED AT THE ARTERIAL END CONNECTOR. AFTER INSERTION IT WAS FOUND THAT THE CONNECTION BETWEEN THE CATHETER CONNECTOR AND THE CATHETER WAS LOOSE, THE CATHETER AND CONNECTER WERE ADJUSTED AND THE CONNECTOR COMPLETELY DETACHED. THE DEVICE WAS IMMEDIATELY REMOVED AND ANOTHER CATHETER WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7868365 ↗
• MalfunctionApr 4, 2018Dent in Material

  IT WAS REPORTED BY THE NURSE THAT DURING THE USE OF THE DEVICE FOR THE THIRD TIME AFTER CATHETERIZATION, IT WAS FOUND THAT THE INDENTATION AT THE THUMB CLIP OF THE CATHETER COULD NOT BE REBOUNDED, RESULTING IN NARROW TUBING WHICH AFFECTS NORMAL BLOOD FLOW, THEN THE VENOUS PRESSURE INCREASED RESULTING IN THE DEVICE ALARMING. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7395995 ↗