HemoStar Long-Term Hemodialysis Catheter 5833270Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00801741013324), received between Oct 23, 2018 and Aug 14, 2024 — classified as 10 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (3 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 14, 2024Fluid/Blood Leak; Fracture; Fluid/Blood Leak; Fracture

  IT WAS REPORTED THAT DURING A DIALYSIS CATHETER PLACEMENT PROCEDURE, THE NEEDLE WAS ALLEGEDLY LEAKING. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19979202 ↗
• MalfunctionAug 17, 2023Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT PRIOR TO A DIALYSIS CATHETER PLACEMENT PROCEDURE, THERE SEEMED TO BE SOMETHING WRONG WITH THE LABEL FOR THE CATHETER. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17564030 ↗
• MalfunctionSep 8, 2022Packaging Problem; Packaging Problem

  IT WAS REPORTED THAT PRIOR TO A DIALYSIS CATHETER PLACEMENT PROCEDURE, THE DEVICE ALLEGEDLY HAD A PACKAGING PROBLEM. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15376568 ↗
• MalfunctionNov 11, 2021Fluid/Blood Leak; Suction Problem; Fluid/Blood Leak; Suction Problem

  IT WAS REPORTED THAT DURING DIALYSIS CATHETER PLACEMENT PROCEDURE, THE PUNCTURE NEEDLE ALLEGEDLY LEAKED AND UNABLE TO ASPIRATE. ANOTHER NEEDLE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12792209 ↗
• MalfunctionSep 9, 2021Loss of or Failure to Bond; Loss of or Failure to Bond

  IT WAS REPORTED THAT SOME TIME POST CATHETER PLACEMENT, CUFF OF THE DEVICE ALLEGEDLY FELL OFF. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12447300 ↗
• MalfunctionSep 9, 2021Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT DURING A PROCEDURE, THE CUFF OF THE DEVICE ALLEGEDLY FELL OFF. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12445140 ↗
• MalfunctionApr 27, 2021Fluid/Blood Leak; Fracture; Migration; Fluid/Blood Leak; Fracture; Migration

  IT WAS REPORTED THAT POST PROCEDURE, THE CATHETER FITTING ALLEGEDLY DAMAGED. IT WAS FURTHER REPORTED THAT THE CATHETER ALLEGEDLY MIGRATED. THE PROCEDURE WAS COMPLETED BY USING ANOTHER DEVICE. 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 11730380 ↗
• MalfunctionDec 23, 2019Fracture; Fracture

  IT WAS REPORTED THAT SOME TIME POST DIALYSIS CATHETER PLACEMENT, THE CATHETER WAS ALLEGEDLY FRACTURED. REPORTEDLY, THE DEVICE WAS REPLACED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9513070 ↗
• MalfunctionNov 5, 2019Defective Component; Defective Component

  IT WAS REPORTED THAT DURING DIALYSIS CATHETER PLACEMENT, THE PLASTIC SLEEVE OF THE TUNNELER COMPONENT ALLEGEDLY BROKE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9282694 ↗
• MalfunctionOct 23, 2018Material Deformation; Material Deformation

  IT WAS REPORTED THAT DURING CATHETER PLACEMENT BOTH LUMENS WERE COLLAPSED AT THE LEVEL OF THE CLAMPS. THE CATHETER WAS REMOVED AND A NEW DEVICE WAS PLACED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7997739 ↗