Ballard* Turbo-Cleaning Closed Suction System 98983Recalls & reported problems
Avanos Medical, Inc. · Turbo-Cleaning Closed Suction Catheter, Double Swivel Elbow, WET PAK* · 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
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00609038989839), received between Mar 8, 2023 and Mar 8, 2023 — classified as 1 injury.
The most frequently reported specific device problem is “Break” (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
- Break1
- Gas/Air Leak1
Patient problems
- Hypoventilation1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryMar 8, 2023Break; Gas/Air Leak; Break; Gas/Air Leak
IT WAS REPORTED THAT THE PATIENT'S VENTILATOR INDICATED LOW EXPIRED VOLUMES. A MAJOR AIR LEAK WAS NOTICED AT THE DOUBLE-SWIVEL ELBOW OF THE CLOSED SUCTION CATHETER (CSC), WHICH WAS CRACKED. WHILE TRYING TO CHANGE THE CSC, THE DOUBLE-SWIVEL ELBOW BROKE INTO TWO PIECES. AFTER ONE MINUTE OF TRYING TO REMOVE THE CSC (DIFFICULTY UNHOOKING BECAUSE IT WAS STUCK), IT WAS REPLACED. THE PATIENT WAS POORLY VENTILATED FOR SEVERAL HOURS WITH LEAKAGE OF PRESSURE. DIFFICULTY REMOVING THE DAMAGED CSC RESULTED IN THE PATIENT NOT BEING VENTILATED FOR 1 MINUTE. PER ADDITIONAL INFORMATION RECEIVED ON 2MAR2023, ¿THERE WERE NO IMMEDIATE CONSEQUENCES FOR THE PATIENT.¿
Patient problems: Hypoventilation
MAUDE report 16507245 ↗
Other CATHETERS, SUCTION, TRACHEOBRONCHIAL devices
- Ballard* Closed Suction System 93826Avanos Medical, Inc. · CATHETERS, SUCTION, TRACHEOBRONCHIAL1 recall70 reports
- Ballard* Closed Suction System 92431Avanos Medical, Inc. · CATHETERS, SUCTION, TRACHEOBRONCHIAL78 reports
- Ballard* Turbo-Cleaning Closed Suction System 98965Avanos Medical, Inc. · CATHETERS, SUCTION, TRACHEOBRONCHIAL1 recall16 reports
- Medline DYNCPDS14Medline Industries, Inc. · CATHETERS, SUCTION, TRACHEOBRONCHIAL1 recall16 reports
- Ballard* Turbo-Cleaning Closed Suction System 98263Avanos Medical, Inc. · CATHETERS, SUCTION, TRACHEOBRONCHIAL1 recall11 reports
- Ballard* Closed Suction System for Adults 98310Avanos Medical, Inc. · CATHETERS, SUCTION, TRACHEOBRONCHIAL1 recall1 death9 reports
- Medline DYNCPTP14TMedline Industries, Inc. · CATHETERS, SUCTION, TRACHEOBRONCHIAL1 recall6 reports
- Medline DYNCPTP14Medline Industries, Inc. · CATHETERS, SUCTION, TRACHEOBRONCHIAL1 recall4 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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