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Ballard* Turbo-Cleaning Closed Suction System 98969Recalls & reported problems

Avanos Medical, Inc. · Turbo-Cleaning Closed Suction Catheter, Double Swivel Elbow - Adult · Class 1

All models of Ballard* Turbo-Cleaning Closed Suction System (16)

Data updated Oct 18, 2026 from official FDA records · Editorial policy

Adverse event reports
2
Deaths reported
0
Injuries reported
1
Recalls naming it
0

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00609038989693), received between Apr 12, 2021 and May 13, 2021 — classified as 1 injury, 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Device problems

  • Disconnection1
  • Material Twisted/Bent1

Patient problems

  • Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
  • Laceration(s) of Esophagus1
  • No Clinical Signs, Symptoms or Conditions1

Recent adverse event reports

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

  • MalfunctionMay 13, 2021Disconnection; Disconnection

    IT WAS REPORTED THAT THE HOSPITAL IS EXPERIENCING ISSUES WITH "THE KITS DISCONNECTING FROM THE TRACHEOSTOMY." ADDITIONAL INFORMATION RECEIVED 30-APR-2021 INDICATED THE EVENT "MAY BE USER ERROR AND THEY [THE HOSPITAL] COULD ACTUALLY ONLY CONFIRM THAT THIS INCIDENT HAD OCCURRED ON ONE PATIENT." ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NOT YET RECEIVED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 11816184 ↗
  • InjuryApr 12, 2021Material Twisted/Bent; Material Twisted/Bent

    IT WAS REPORTED THAT THE CATHETER WAS KINKED AND AFTER USE, "POSSIBLY CAUSED SOME BLEEDING IN THE PATIENT." THE DEVICE WAS USED FOR TWO HOURS BEFORE BEING REPLACED AT 1AM ON (B)(6) 2021, AND THE PATIENT IMPROVED OVER THE COURSE OF THE SHIFT AND BY 8PM ON (B)(6) 2021, HE "WAS MUCH BETTER WITH ONLY MINIMALLY BLOOD STAINED SPUTUM." IT WAS FURTHER REPORTED BY THE NURSE THAT "THE PATIENT ONLY HAD SALINE NEBS AND TO TREAT IT AND I SWITCHED HIM DOWN TO A SMALLER 12FR CATHETER TO HELP MINIMIZE IRRITATION TO HIS AIRWAY FOR THE TIME BEING. THE MAIN TREATMENT WAS JUST SPOTTING THAT THE CATHETER WAS THE PROBLEM AND REMOVING IT." NO FURTHER INFORMATION PROVIDED.

    Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Laceration(s) of Esophagus

    MAUDE report 11648079 ↗

Other CATHETERS, SUCTION, TRACHEOBRONCHIAL devices

All CATHETERS, SUCTION, TRACHEOBRONCHIAL devices →

Sources and updates

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