HemoStar Long-Term Hemodialysis Catheter 5835150Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00801741013485), received between Dec 16, 2016 and Aug 7, 2019 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Material Deformation” (2 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 7, 2019Defective Component; Defective Component

  IT WAS REPORTED THAT PRIOR TO THE PLACEMENT OF THE DIALYSIS CATHETER, THE PLASTIC STEM OF THE TUNNELER ALLEGEDLY BROKE. REPORTEDLY, ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Patient Involvement

  MAUDE report 8870504 ↗
• MalfunctionAug 7, 2019Material Deformation; Material Deformation

  IT WAS REPORTED THAT SOMETIME POST DIALYSIS CATHETER PLACEMENT, WHEN THE EXTENSION LEG WAS UNCLAMPED, THE LUMEN REMAINED COLLAPSED, FLAT, AND NARROW, CAUSING RESTRICTION OF BLOOD FLOW, REDUCTION IN PUMP SPEED, AND REDUCTION IN CLEARANCE IN THE DIALYSIS TREATMENT. IT WAS FURTHER REPORTED THAT THE PATIENT CONTINUED TO RECEIVED REDUCED-EFFICIENCY DIALYSIS TREATMENTS. REPORTEDLY, THE DEVICE WAS REMOVED AND REPLACED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8870435 ↗
• MalfunctionAug 7, 2019Material Deformation; Material Deformation

  IT WAS REPORTED THAT SOMETIME POST DIALYSIS CATHETER PLACEMENT, WHEN THE EXTENSION LEG WAS UNCLAMPED, THE LUMEN REMAINED COLLAPSED, FLAT, AND NARROW, CAUSING RESTRICTION OF BLOOD FLOW, REDUCTION IN PUMP SPEED, AND REDUCTION IN CLEARANCE IN THE DIALYSIS TREATMENT. IT WAS FURTHER REPORTED THAT THE PATIENT CONTINUED TO RECEIVED REDUCED-EFFICIENCY DIALYSIS TREATMENTS. REPORTEDLY, THE DEVICE WAS REMOVED AND REPLACED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8870357 ↗
• MalfunctionSep 27, 2018Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT DURING INFUSION OF A CYTOTOXIC AGENT/CHEMOTHERAPY THERE WAS AN ALLEGED LEAK, AS THE PATIENT STATED THE DRESSING AROUND THE PORT SITE WAS WET. THE HEALTHCARE PROFESSIONAL IMPLEMENTED THE EXTRAVASATION POLICY AND DISCONTINUED THE ADMINISTRATION OF CHEMOTHERAPY. THE DEVICE WAS REMOVED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: Infiltration into Tissue

  MAUDE report 7914633 ↗
• MalfunctionFeb 28, 2018Device Dislodged or Dislocated

  IT WAS REPORTED THAT THERE WAS A DISLODGEMENT OF THE HEMOSTAR ALPHA CURVE. ALLEGEDLY THE CATHETER SLIPPED OUT AFTER ONE MONTH OF INSERTION. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7304218 ↗
• MalfunctionDec 16, 2016Uncoiled; Material Integrity Problem

  IT WAS ORIGINALLY REPORTED BY THE FACILITY THAT THE GUIDEWIRE WAS "FAULTY". BARD SALES REPRESENTATIVE CLARIFIED THAT WHEN HE INSPECTED THE WIRE, HE NOTICED IT WAS UNCOILED. THE FACILITY REPORTED TO HIM THAT THE PROCEDURE WAS COMPLETED WITH A NEW GUIDEWIRE AND THIS OCCURRED DURING THE EARLY STAGE OF INSERTION WITH THE NEEDLE AND GUIDEWIRE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6183533 ↗