Split Cath® III ASPC24-3E.Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00884908003512), received between Oct 23, 2018 and Aug 22, 2019 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Break” (1 report).

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 22, 2019Leak/Splash; Leak/Splash

  AFTER BEING IMPLANTED FOR APPROXIMATELY 12 MONTHS, THE LUMEN OF THE CATHETER WAS NOTED TO BALLOON. A SLICE/CUT APPEARS ON A PORTION OF THE LUMEN WHICH WAS UNDER A GAUZE DRESSING. THE BALLOONING WAS REPORTED TO OCCUR AFTER THE CATHETER WAS CLAMPED TO BLOCK THE BLOOD FROM LEAKING OUT FROM THE SLICE. THE CATHETER WAS USED ONLY FOR DIALYSIS AND WAS NOT USED FOR POWER INJECTIONS. CATHETER WAS REMOVED.

  Patient problems: Blood Loss

  MAUDE report 8921139 ↗
• MalfunctionOct 23, 2018Break; Break

  AT THE END OF PLACEMENT PROCEDURE WITH SELDINGER TECHNIQUE ECHO-GUIDED, WHILE REMOVING TEAR-AWAY SHEATH, TEAR-AWAY TABS BROKE PREVENTING THIS OPERATION. KLEMMER FORCEPS WERE USED AFTERWARD TO REMOVE THE SHEATHS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7994572 ↗