EQUISTREAM Long-Term Hemodialysis Catheter 5905280Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00801741013812), received between Mar 20, 2019 and Feb 14, 2025 — classified as 1 death, 4 malfunctions.

The most frequently reported specific device problem is “Defective Component” (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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• DeathFeb 14, 2025Fluid/Blood Leak; Material Split, Cut or Torn; Fluid/Blood Leak; Material Split, Cut or Torn

  IT WAS REPORTED THAT WHILE THE PATIENT'S CAREGIVER WAS CHANGING THE DRESSING AROUND THE DIALYSIS CATHETER, THE TUBING WAS INADVERTENTLY CUT BENEATH ONE OF THE PORTS. IT WAS FURTHER REPORTED THAT THE PATIENT BEGAN BLEEDING OUT THROUGH THE CUT CATHETER END AND COLLAPSED. REPORTEDLY, THE CAREGIVER CALLED 911 AND THE PATIENT WAS TRANSPORTED TO THE EMERGENCY ROOM. THE BLEEDING COULD NOT BE STOPPED UNTIL THE TUBE WAS CLAMPED IN THE EMERGENCY ROOM. DESPITE ALL EFFORTS INCLUDING TRANSFUSION, THE PATIENT COULD NOT BE RESUSCITATED. THE PATIENT EXPIRED DUE TO EXSANGUINATION.

  Patient problems: Exsanguination

  MAUDE report 21382410 ↗
• MalfunctionAug 12, 2019Restricted Flow rate; Restricted Flow rate

  IT WAS REPORTED THAT SOME TIME AFTER THE PLACEMENT OF THE DIALYSIS CATHETER, THE FLOW RATE WAS ALLEGEDLY DECREASED. REPORTEDLY, THE DIALYSIS MACHINE ALARM GOES OFF. IT WAS FURTHER REPORTED THAT THE HEALTH CARE PROVIDER WAS ABLE TO INFUSE AND ASPIRATE SUCCESSFULLY AFTER THE DECLOTTING PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8884041 ↗
• MalfunctionJun 5, 2019Defective Component; Defective Component

  IT WAS REPORTED THAT UPON OPENING THE DIALYSIS CATHETER INSERTION KIT, THE PLASTIC TIP OF THE TUNNELER WAS ALLEGEDLY FOUND TO BE BROKEN. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Patient Involvement

  MAUDE report 8670770 ↗
• MalfunctionApr 26, 2019Defective Component; Defective Component

  IT WAS REPORTED THE TIP OF THE TUNNELER ALLEGEDLY BROKE. REPORTEDLY, A NEW DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8558598 ↗
• MalfunctionMar 20, 2019Defective Component; Defective Component

  IT WAS REPORTED THE TIP OF THE TUNNELER ALLEGEDLY BROKE. REPORTEDLY, A NEW DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8436847 ↗