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Cure Catheter® Closed System CS10Recalls & reported problems

Convatec, Purchasing Department · Closed System Complete Urinary Catheterization System, Straight Tip · Class 2

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 00815947020659), received between Apr 13, 2022 and Apr 13, 2022 — classified as 1 malfunction.

The most frequently reported specific device problem is “Contamination /Decontamination Problem” (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

  • Contamination /Decontamination Problem1

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.

  • MalfunctionApr 13, 2022Contamination /Decontamination Problem; Contamination /Decontamination Problem

    END USER'S MOTHER STATES SHE FOUND "BROWNISH SPOTS ON THE FINGER TIPS OF THE CLEAR PLASTIC GLOVES IN HER CURE 10FR CATHETER KITS" THAT SHE USED TO CATHERIZE HER SON. THE GLOVES WERE DISCARDED, HOWEVER SHE SAID "THE SCHOOL NURSE DID USE THEM WHEN SHE CATH'D ELI WHEN SHE FOUND THEM AS WELL BUT NO HARM REPORTED."

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 14104246 ↗

Other Tray, Catheterization, Sterile Urethral, With Or Without Catheter (Kit) devices

All Tray, Catheterization, Sterile Urethral, With Or Without Catheter (Kit) devices →

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