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SPLIT CATH® III ASPC28-3PCE.Recalls & reported problems

Medical Components, Inc. · 14F X 28CM PRE-CURVED SPLIT CATH® III CATHETER SET (CUFF 23CM FROM TIP) · Class 2 · Implant

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

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00884908003758), received between Jul 12, 2018 and Jul 12, 2018 — classified as 1 malfunction.

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

Device problems

  • Disconnection1

Patient problems

  • No Known Impact Or Consequence To Patient1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • MalfunctionJul 12, 2018Disconnection; Disconnection

    THE PATIENT TOOK OUT THE CATHETER INSERTED THE DAY BEFORE. THE SUTURE WING AND THE SUTURE WERE STILL ATTACHED TO THE PATIENT'S SKIN, THE SUTURE WAS NOT RIPPED OFF. THE CATHETER SEPARATED FROM THE SUTURE WING.

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 7682727 ↗

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.