HEMO-CATH® DMC101243Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00884908140835), received between Apr 15, 2021 and Jan 22, 2026 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 22, 2026Leak/Splash

  PATIENT RECEIVED NEW HD CATHETER (B)(6) 2026, THE LINE WAS ACCESSED AND USED FOR HEMODIALYSIS BOTH (B)(6) 2026 AND (B)(6) 2026 WITHOUT ISSUE. WHEN LINE ACCESSED (B)(6) 2026, NOTED PIN PRICK SPRAY/LEAK FROM BOTH RED AND BLUE LUMENS. NEPHROLOGIST NOTIFIED, LABS COLLECTED. AFTER REVIEWING LABS NEPHROLOGIST DETERMINED LABS ARE STABLE AND DIALYSIS WAS NOT URGENT. IR TEAM CONTACTED DIRECT BY NEPHROLOGIST FOR NEW LINE PLACEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24145159 ↗
• MalfunctionJan 20, 2023Leak/Splash; Leak/Splash

  UPON ROUTINE ASSESSMENT OF THE PATIENT FOR DIALYSIS, SPOTS OF FRANK BLOOD NOTED ON PATIENT'S SHIRT. FURTHER INSPECTION OF THE CATHETER REVEALED A PIN HOLE DEFECT ON THE ARTERIAL PORT OF THE HEMODIALYSIS CATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16216055 ↗
• MalfunctionApr 15, 2021Air/Gas in Device; Air/Gas in Device

  THE BLUE LUMEN OF THE APHERESIS LINE WAS ACCESSED PER POLICY. THE RED LUMEN OF THE CATHETER WAS NOTED TO HAVE AIR IN IT. PATIENT STATED THAT THERE WAS AIR OBSERVED IN THE LINE THE WEEK BEFORE ALSO. SHE DENIES THE CAP COMING OFF OR ANY NOTABLE LEAKAGE. NO CRACKS WERE VISIBLE IN THE LINE BY THE APHERESIS UNIT NURSES OR SURGERY TEAM WHO CAME TO CONSULT WHEN THE AIR WAS DISCOVERED. DRESSING REMOVED BY SURGERY TEAM, HEPARIN DWELL REMOVED, AND LINE FLUSHED WITH NS WHILE THE GENERAL SURGERY RESIDENT, PA AND RN WATCHED FOR LEAKING. NO LEAKS NOTED. DUE TO UNEXPLAINED RECURRENCE OF AIR IN THE LINE AND RISK FOR HARM, A PLAN WAS MADE FOR THE CENTRAL LINE TO BE REMOVED IN THE OR. THE LINE WAS REMOVED WITHOUT COMPLICATIONS BUT THE LINE WAS NOT SAVED BY THE SURGERY TEAM IN THE OR SO WE ARE UNABLE TO SEQUESTER THE LINE FOR EXAMINATION BY THE COMPANY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11674733 ↗