Split Cath® III ASPC28-3E.Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00884908003710), received between Apr 21, 2017 and Mar 16, 2020 — classified as 2 injuries, 2 malfunctions.

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

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 16, 2020Leak/Splash; Leak/Splash

  AFTER HAVING CONNECTED THE PATIENT AIR BUBBLE ALARM FROM THE DIALYSIS MACHINE. LOTS OF BUBBLES ON THE ARTERIAL EXTENSION. TREATMENT INTERRUPTION IN ORDER TO CHECK THE LUER LOCK CONNECTION: OK NO ISSUE. TREATMENT CONTINUITY BUT NEW AIR BUBBLE ALARM. VISUALLY, AIR BUBBLES WERE DRAWN DIRECTLY INTO THE ARTERIAL EXTENSION. TREATMENT INTERRUPTION: LINE DISCONNECTION, RINSING WITH WATER, INSERTION OF TIPS. VISUALLY, BLOOD WAS FLOWING SLIGHTLY BETWEEN THE LUMEN AND THE EXTENSION ADAPTOR. REMOVAL OF THE CATHETER THEN INSERTION OF A NEW. THE CATHETER SEEMS TO HAVE A TEAR. THE PATIENT IS NOW IN GOOD CONDITION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9836862 ↗
• MalfunctionJan 4, 2019Leak/Splash; Leak/Splash

  WHEN CONNECTING THE PATIENT, AIR WAS INSIDE THE 2 CATHETER BRANCHES. THE DIALYSIS SESSION WAS IMMEDIATELY STOPPED AND THE DOCTORS WERE CALLED. BLOOD PRESENCE WAS ON THE DRESSING. WITH A VISUAL INSPECTION, IT WAS NOTICED A CUT BETWEEN THE TRIANGLE AND THE CATHETER PART ON THE PATIENT SIDE. THE CATHETER WAS REMOVED BY THE DOCTOR. NO CLINICAL CONSEQUENCES FOR THE PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8217626 ↗
• InjuryMay 2, 2018Connection Problem; Connection Problem

  THE CONNECTION BETWEEN THE VENOUS BLOOD LINE AND THE CATHETER CONNECTOR SEPARATED 30 MIN BEFORE THE END OF THE DIALYSIS. THE PATIENT LOST A LOT OF BLOOD.

  Patient problems: Blood Loss

  MAUDE report 7479773 ↗
• InjuryApr 21, 2017Leak/Splash; Defective Component; Leak/Splash

  WHEN INSERTING THE DILATOR WITH THE CHECK-VALVE DURING THE CATHETER PLACEMENT, THE VALVE HAS NOT WORKED AND A SIGNIFICANT AMOUNT OF BLOOD FLOWED OUT.

  Patient problems: Blood Loss; No Known Impact Or Consequence To Patient

  MAUDE report 6510814 ↗