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Split Cath® III ASPC24P-XLRecalls & reported problems

Medical Components, Inc. · 10F X 24CM Split Cath® III CATHETER SET (CUFF 21CM FROM TIP) · Class 2 · Implant

Adverse event reports
3
Deaths reported
0
Injuries reported
1
Recalls naming it
0

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00884908003581), received between Aug 20, 2019 and Oct 24, 2022 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Break” (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

Device problems

  • Break2
  • Improper Flow or Infusion1

Patient problems

  • Device Embedded In Tissue or Plaque1
  • No Clinical Signs, Symptoms or Conditions1
  • No Known Impact Or Consequence To Patient1
  • Renal Failure1

Recent adverse event reports

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

  • MalfunctionOct 24, 2022Break; Break

    EXTENSION TUBING TORN AT THE HUB.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 15657567 ↗
  • MalfunctionJul 22, 2020Improper Flow or Infusion; Improper Flow or Infusion

    POSSIBLE FISTULA WITHIN LINE PROBLEMS WITH LOW VENOUS PRESSURE ON HD MACHINE. PARENTS SAW TINY AIR BUBBLE GO IN THROUGH BLUE LUMEN AND COME STRAIGHT OUT THE RED LUMEN. ALSO, BLOOD SHOULD COME OUT OF THE ARTERIAL LUMEN VERY DARK AS IT SHOULD HAVE HAD NO MIXTURE WITH SALINE HOWEVER USING THIS LINE THE BLOOD CAME OUT THE ARTERIAL LUMEN VERY OBVIOUSLY MIXED WITH SALINE. THOUGHT TO BE SOME COMMUNICATION BETWEEN ARTERIAL LUMEN AND VENOUS LUMEN WITHIN THE LINE ITSELF.

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 10308201 ↗
  • InjuryAug 20, 2019Break; Break

    TUNNELED HEMODIALYSIS CATHETER WAS NOTED AS HAVING PROBLEMS WITH FLOW DURING DIALYSIS SESSIONS SO THE RENAL TEAM ASKED THAT IT BE REMOVED. THE CATHETER WAS REMOVED SUCCESSFULLY AT THE BEDSIDE. HOWEVER, A FOREIGN BODY OF THE CHEST WALL WAS NOTED AFTER THE REMOVAL. PATIENT WAS TRANSFERRED TO THE SEDATION AREA WHERE A SINGLE PIECE OF OPAQUE WHITE PLASTIC TUBING, CONSISTENT WITH HEMODIALYSIS CATHETER, WAS REMOVED

    Patient problems: Device Embedded In Tissue or Plaque; Renal Failure

    MAUDE report 8909784 ↗

Other Catheter, hemodialysis, implanted devices

All Catheter, hemodialysis, implanted devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.