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Hemo-Cath® MCDLTSL18PRecalls & reported problems

Medical Components, Inc. · 8F X 18CM Hemo-Cath® SILICONE DOUBLE LUMEN CATHETER WITH CUFF TRAY · Class 2 · Implant

Adverse event reports
2
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00884908026115), received between Apr 22, 2019 and Jul 30, 2019 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (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

  • Adverse Event Without Identified Device or Use Problem1
  • Insufficient Device Problem Information1

Patient problems

  • No Known Impact Or Consequence To Patient2

Recent adverse event reports

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

  • MalfunctionJul 30, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    AIR IN LUMENS, EXCESSIVE AMOUNT OF AIR WITH ASPIRATION. IMPLANTED FOR 6 MONTHS.

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 8842736 ↗
  • MalfunctionApr 22, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

    DURING ASPIRATION LARGE AMOUNTS OF AIR WAS REPORTED IN THE LUMENS. LUMENS WERE CLAMPED, CATHETER WAS LATER REPLACED.

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 8537197 ↗

Other CATHETER, SUBCLAVIAN devices

All CATHETER, SUBCLAVIAN devices →

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