SLX Hemo-CathRecalls & reported problems across all models

We found 4 models of SLX Hemo-Cath by Medical Components, Inc. in the FDA's device registry (GUDID). Together they are named in 32 adverse event reports in the FDA's MAUDE database, received between Mar 20, 2018 and Oct 31, 2024 — classified as 1 injury, 31 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (16 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported SLX Hemo-Cath problems

SLX Hemo-Cath models

4 models, most reported first. Each model has its own page with its reports, recalls and device details.

• SLX Hemo-Cath® MC101243

  Catheter, hemodialysis, implanted
  24 reports
• SLX Hemo-Cath® MC101242

  Catheter, hemodialysis, implanted
  5 reports
• SLX Hemo-Cath® MC101241

  Catheter, hemodialysis, implanted
  2 reports
• SLX Hemo-Cath® MC061424

  CATHETER, SUBCLAVIAN
  1 report

Recent SLX Hemo-Cath adverse event reports

The 15 most recent reports across all models, 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 ↗
• MalfunctionDec 19, 2022Leak/Splash; Leak/Splash

  HOME VISIT TO DO INITIAL DRESSING CHANGE 24 HOURS POST INSERTION FOR CVAD. BUBBLES NOTED IN BOTH LUMENS OF CVAD. CLIENT CALLED CCI AND THEY INFORMED HIM THE BUBBLES WILL BE ASPIRATED AT HIS NEXT MAINTENANCE/FLUSH. LINE REMOVED FOR SUSPECTED OBSTRUCTION OF THE DISTAL (BLUE) LUMEN. WITH RESPECT TO THE BLUE LUMEN, ATTEMPTS TO WITHDRAW BLOOD INTO THE SYRINGE WERE UNSUCCESSFUL. APPROXIMATELY 10 CC OF OMNIPAQUE WERE INJECTED, WHICH SWIFTLY OPACIFIED THE CATHETER. ALTHOUGH SOME FREE FLOW OF CONTRAST MEDIA OCCURRED, ACCUMULATION WAS OBSERVED AROUND THE CATHETER TIP, CONFIRMING OBSTRUCTION BY A ONE- WAY FLAP/VALVE MECHANISM. WITH RESPECT TO THE RED LUMEN, BLOOD WITHDRAWAL WAS NORMAL AND THE CATHETER FLUSHED FREELY. CATHETER REMOVAL AND REPLACEMENT WERE SUGGESTED AND COMPLETED - SAMPLE NOT RETAINED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16003420 ↗
• MalfunctionDec 15, 2022Leak/Splash; Leak/Splash

  10-12 BUBBLES IN CLEAR PORTION OF BROVIAC LINE (BETWEEN THE CLAMPS AND THE INSERTION SITE).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15987016 ↗
• MalfunctionDec 15, 2022Leak/Splash; Leak/Splash

  AIR IN CVC LINE, NO BLOOD RETURN OR ABLE TO FLUSH AFTER TAKING AIR OUT. ALTEPLASE ADMINISTERED TO LINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15986995 ↗
• MalfunctionDec 15, 2022Leak/Splash; Leak/Splash

  ARRIVED IN THE HOME TO DO CVAD MAINTENANCE. APPEARED TO BE EITHER 100% AIR OR 100% FLUID. NO AIR BUBBLES SEEN. WRITER REMOVED THE CURRENT CAP, THEN ATTACHED FLUSH SYRINGE WITH NEW PRIMED CAP AND WRITER PULLED BACK. WRITER NOTED AIR COME INTO THE SYRINGE WITH NO RESISTANCE AND THEN SMALL FLUID WITH AIR IN BETWEEN. CLIENT STATES HE ALSO HAD AIR IN HIS LINE LAST WEEK AND HAD TO GO INTO CCI FOR MAINTENANCE. LINE REMOVED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15986956 ↗
• MalfunctionNov 1, 2022Air/Gas in Device; Air/Gas in Device

  LARGE AIR BUBBLE NOTED IN THE BLUE LUMEN EXTENSION OF CLIENT'S DUAL LUMEN CENTRAL LINE. CATHETER REMAINS IMPLANTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15708705 ↗
• 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 ↗
• MalfunctionJul 15, 2021Air/Gas in Device; Air/Gas in Device

  AIR BUBBLES WERE NOTED IN THE ARTERIAL EXTENSION LINE. CATHETER REMAINS IMPLANTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12177235 ↗
• MalfunctionJul 15, 2021Air/Gas in Device; Air/Gas in Device

  AIR BUBBLES WERE NOTED IN BOTH EXTENSION LINES. CATHETER REMAINS IMPLANTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12177178 ↗
• MalfunctionJul 15, 2021Air/Gas in Device; Air/Gas in Device

  AIR BUBBLES WERE NOTED IN THE VENOUS EXTENSION LINE. CATHETER REMAINS IMPLANTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12177082 ↗
• MalfunctionJul 15, 2021Air/Gas in Device; Air/Gas in Device

  AIR BUBBLES WERE NOTED IN THE ARTERIAL EXTENSION LINE. CATHETER REMAINS IMPLANTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12176900 ↗
• MalfunctionJul 15, 2021Air/Gas in Device; Air/Gas in Device

  AIR BUBBLES WERE NOTED IN BOTH EXTENSION LINES. CATHETER REMAINS IMPLANTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12176748 ↗
• MalfunctionJul 15, 2021Air/Gas in Device; Air/Gas in Device

  AIR BUBBLES WERE NOTED IN BOTH EXTENSION LINES. AIR WAS REMOVED WITH A SYRINGE. NO FURTHER EVIDENCE OF AIR FOLLOWING PROCEDURE. CATHETER REMAINS IMPLANTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12176591 ↗
• MalfunctionJul 15, 2021Air/Gas in Device; Air/Gas in Device

  AIR BUBBLES WERE NOTED IN THE ARTERIAL EXTENSION LINE. ONE WEEK LATER AIR BUBBLES NOTED IN BOTH EXTENSION LINES. CATHETER REMAINS IMPLANTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12176482 ↗

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