SLX Hemo-Cath® MC101242Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00884908082999), received between Dec 2, 2020 and Oct 31, 2024 — classified as 5 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. 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.

• MalfunctionOct 31, 2024Break; Break

  WHILE REMOVING THE INDWELLING CATHETER FROM THE TUNNEL AFTER HAVING DISSECTED THE TISSUE SURROUNDING THE CUFF THE CATHETER TORE IN HALF AT THE CUFF POINT COMPLETELY. THE DISTAL HALF WAS COMPLETELY REMOVED ANT THE PROXIMAL HALF WAS FREE FLOATING ON THE GUIDE WIRE PLACED THROUGH THE CATHETER SVC TO RA TO IVC AT THE BEGINNING OF THE PROCEDURE. A CUTDOWN WAS PERFORMED OVER A MORE PROXIMAL PART OF THE CATHETER AT THE CUFF AND IT WAS SAFELY REMOVED WITHOUT EMBOLIZING TO THE PULMONARY ARTERIES. A NEW PERMCATH WAS THEN INTRODUCED OVER THE WIRE AFTER HAVING MANEUVERED THE WIRE BACK THROUGH THE ORIGINAL TUNNEL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20577791 ↗
• MalfunctionNov 11, 2021Leak/Splash; Leak/Splash

  NOTED PINHOLE IN RED EXTERNAL LUMEN OF HEMO-CATH. CATHETER WAS REMOVED AND REPLACED. NO ADVERSE CLINICAL CONSEQUENCES TO THE PATIENT WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12798552 ↗
• MalfunctionSep 1, 2021Fluid/Blood Leak; Fluid/Blood Leak

  UPON PLACING THE PATIENT BACK ON A NEW CRRT CIRCUIT, BEDSIDE STAFF NOTICED THAT THE EXTERNAL PORTION OF THE CATHETER WAS OOZING BLOOD. A HOLE WAS IDENTIFIED. THE HOLE WAS PROXIMAL TO THE PATIENT, AWAY FROM ANY CONNECTION POINTS OR CLAMPS. CRRT TREATMENT WAS STOPPED, LINE WAS CLAMPED, AND PATIENT WAS TAKEN TO IR FOR LINE EXCHANGE. TWO DAYS LATER CRRT ALARMED FOR LOW ACCESS PRESSURES. BEDSIDE NURSE REMOVED PATIENT FROM CIRCUIT TO ASSESS LINE. WHEN SHE TRIED FLUSHING THE LINE, SHE NOTICED OOZING COMING FROM THE EXTERNAL PORTION OF THE CATHETER. THE HOLE WAS PROXIMAL TO THE PATIENT, AWAY FROM ANY CONNECTION POINTS OR CLAMPS. SHE PLACED A TEGADERM OVER THE HOLE AND CLAMPED THE LINE. PATIENT TAKEN TO IR FOR LINE EXCHANGE. BOTH DEVICES ARE FROM THE SAME LOT.

  Patient problems: Unspecified Infection

  MAUDE report 12408416 ↗
• MalfunctionMar 11, 2021Material Puncture/Hole; Material Puncture/Hole

  CATHETER WAS EXCHANGED OVER A GUIDEWIRE BUT DURING HEMODIALYSIS THE SAME DAY SMALL HOLES WERE NOTED IN THE EXTENSION LINE, RESULTING IN BLOOD LEAKING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11465018 ↗
• MalfunctionDec 2, 2020Leak/Splash; Leak/Splash

  DURING THE HAEMODIALYSIS SESSION WAS OBSERVED A SEMICIRCULAR CUT ON THE ARTERIAL BRANCH OF THE CATHETER. REPORT INDICATED THE PATIENT LOST 20-100CC OF BLOOD. THE CATHETER WAS CHANGED.

  Patient problems: Blood Loss

  MAUDE report 10937130 ↗