HemoStar Long-Term Hemodialysis Catheter 5835190Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 00801741013492), received between Mar 13, 2018 and Oct 18, 2024 — classified as 3 injuries, 12 malfunctions.

The most frequently reported specific device problem is “Fracture” (8 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 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 18, 2024Fracture; Fracture

  IT WAS REPORTED THAT DURING A DIALYSIS CATHETER PLACEMENT PROCEDURE, THE PROTECTIVE SLEEVE AROUND THE HUB WAS ALLEGEDLY SPLIT. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20478986 ↗
• MalfunctionOct 16, 2024Fracture; Deformation Due to Compressive Stress; Fracture; Deformation Due to Compressive Stress

  IT WAS REPORTED THAT SOMETIME POST A DIALYSIS CATHETER PLACEMENT, IT WAS FOUND THAT THE CRACK HAD ALLEGEDLY APPEARED ON THE LUMEN OF LINE. IT WAS FURTHER REPORTED THAT THE WHITE PROTECTIVE SLEEVE IN THE HUB WAS ALLEGEDLY TORN. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20467827 ↗
• MalfunctionOct 16, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT SOMETIMES POST A DIALYSIS CATHETER PLACEMENT, THE RED HUB ON LUMEN ALLEGEDLY MOVED AND SPINS ROUND. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20461306 ↗
• MalfunctionOct 16, 2024Fracture; Detachment of Device or Device Component; Fracture; Detachment of Device or Device Component

  IT WAS REPORTED THAT SOMETIMES POST A DIALYSIS CATHETER PLACEMENT, IT WAS NOTICED THAT CRACKS ALLEGEDLY APPEARED ON THE LUMENS ON A NUMBER OF LINES THAT HAVE BEEN INSERTED TO PATIENTS. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20460950 ↗
• MalfunctionJan 20, 2022Material Opacification; Material Protrusion/Extrusion; Material Opacification; Material Protrusion/Extrusion

  IT WAS REPORTED THAT APPROXIMATELY ONE YEAR POST DIALYSIS 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 13306789 ↗
• MalfunctionJul 21, 2020Fluid/Blood Leak; Fracture; Fluid/Blood Leak; Fracture

  IT WAS REPORTED APPROXIMATELY TWO MONTHS POST PORT IMPLANT, THE DEVICE ALLEGEDLY LEAKED AROUND THE CUFF. IT WAS FURTHER REPORTED THAT, THERE WAS NO ISSUES IN PLACING THE CATHETER. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10300664 ↗
• MalfunctionJul 20, 2020Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT APPROXIMATELY 2 MONTHS POST CUFF PLACEMENT, THE DEVICE ALLEGEDLY HAD A LEAK AROUND THE CUFF. REPORTEDLY, THE CUFF WAS REPAIRED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10294239 ↗
• MalfunctionJul 20, 2020Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT SOMETIME POST CATHETER IMPLANT, THE HEMOSTAR CATHETER WAS ALLEGEDLY FOUND TO LEAK AROUND THE CUFF. HOWEVER, NO ISSUES WERE FOUND WHEN PLACING THE CATHETER. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10294238 ↗
• MalfunctionJul 20, 2020Fluid/Blood Leak; Fracture; Fluid/Blood Leak; Fracture

  IT WAS REPORTED THAT SOMETIME POST CATHETER IMPLANT, THE HEMOSTAR CATHETER WAS ALLEGEDLY FOUND TO LEAK AROUND THE CUFF. HOWEVER, NO ISSUES WERE FOUND WHEN PLACING THE CATHETER. THE PROCEDURE WAS COMPLETED BY REPLACING IT WITH A NEW CATHETER. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10294077 ↗
• InjuryApr 27, 2020Fracture; Fracture

  IT WAS REPORTED THAT APPROXIMATELY 668 DAYS POST PORT PLACEMENT AN ALLEGED FISSURING (SPLIT OR CRACK) WAS IDENTIFIED IN CLOSE PROXIMITY OF THE TRIANGULAR CONNECTION IN THE PRE-CURVED CATHETER. IT WAS FURTHER REPORTED THAT PATIENT HOSPITALIZATION FOR URGENT REPLACEMENT WAS REQUIRED. PATIENT STATUS WAS NOT PROVIDED.

  Patient problems: Injury

  MAUDE report 10003012 ↗
• InjuryApr 27, 2020Fracture; Fracture

  IT WAS REPORTED THAT APPROXIMATELY 73 DAYS POST PORT PLACEMENT AN ALLEGED FISSURING (SPLIT OR CRACK) WAS IDENTIFIED IN CLOSE PROXIMITY OF THE TRIANGULAR CONNECTION IN THE PRE-CURVED CATHETER. IT WAS FURTHER REPORTED THAT PATIENT HOSPITALIZATION FOR URGENT REPLACEMENT WAS REQUIRED. PATIENT STATUS WAS NOT PROVIDED.

  Patient problems: Injury

  MAUDE report 10003005 ↗
• InjuryApr 27, 2020Fracture; Fracture

  IT WAS REPORTED THAT APPROXIMATELY 360 DAYS POST PORT PLACEMENT AN ALLEGED FISSURING (SPLIT OR CRACK) WAS IDENTIFIED IN CLOSE PROXIMITY OF THE TRIANGULAR CONNECTION IN THE PRE-CURVED CATHETER. IT WAS FURTHER REPORTED THAT PATIENT HOSPITALIZATION FOR URGENT REPLACEMENT WAS REQUIRED. PATIENT STATUS WAS NOT PROVIDED.

  Patient problems: Injury

  MAUDE report 10002942 ↗
• MalfunctionOct 4, 2019Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT SOME TIME POST DIALYSIS CATHETER PLACEMENT, THE ARTERIAL LUMEN OF THE DIALYSIS CATHETER ALLEGEDLY ASPIRATED AIR. REPORTEDLY, THE DEVICE WAS REMOVED AND REPLACED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9157741 ↗
• MalfunctionJun 18, 2018Defective Component; Defective Component

  IT WAS REPORTED THAT THE CLAMP ON THE CATHETER WAS CRACKED/BROKEN. THE CATHETER WAS REPAIRED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7611931 ↗
• MalfunctionMar 13, 2018Material Frayed; Material Deformation; Break; Material Frayed; Material Deformation

  IT WAS REPORTED THAT THE WIRE WAS BROKEN NEAR THE CURVED END OF THE CATHETER. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7335697 ↗