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Hemo-Cath® MC101045PRecalls & reported problems

Medical Components, Inc. · 10F X 24CM Hemo-Cath® SILICONE DOUBLE LUMEN CATHETER SET (CUFF 20CM 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 00884908093308), received between Jun 22, 2023 and Jun 22, 2023 — classified as 1 malfunction.

The most frequently reported specific device problem is “Leak/Splash” (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

  • Leak/Splash1

Patient problems

  • No Clinical Signs, Symptoms or Conditions1

Recent adverse event reports

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

  • MalfunctionJun 22, 2023Leak/Splash; Leak/Splash

    DURING DIALYSIS CATHETER WAS NOT FUNCTIONING AND A LEAK WAS NOTED. AFTER REMOVAL A LEAK WAS NOTED PROXIMAL TO THE CUFF.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 17180903 ↗

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.