Ballard* Turbo-Cleaning Closed Suction System 98970Recalls & 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
- 2
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00609038989709), received between Aug 26, 2021 and Oct 29, 2021 — classified as 2 injuries.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (2 reports).
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
- Detachment of Device or Device Component2
Patient problems
- Low Oxygen Saturation2
- Discomfort1
- Distress1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryOct 29, 2021Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT WHEN THE PATIENT COUGHED, THE SYSTEM BECAME "MALADJUSTED" AND RESULTED IN THE PATIENT NO LONGER BEING VENTILATED. THE PATIENT BECAME DESATURATED AND DISTRESSED. THE SYSTEM WAS CHANGED OUT FOR ANOTHER. PER ADDITIONAL INFORMATION RECEIVED 21 OCT 2021, THE EVENT TOOK PLACE IN (B)(6), AND THERE IS NO FURTHER INFORMATION THEY CAN PROVIDE.
Patient problems: Distress; Low Oxygen Saturation
MAUDE report 12720325 ↗InjuryAug 26, 2021Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THE TRACHEOSTOMIZED PATIENT WAS CONNECTED TO A VENTILATOR. WHEN THE PATIENT COUGHED, THE SYSTEM "MISMATCHED FROM THE CANNULA AND THEREFORE THE PATIENT WAS NO LONGER VENTILATED. IN ADDITION, THE SYSTEM INCLUDES A PROBE TO ASPIRATE THE PATIENT'S TRACHEAL SECRETIONS WITHOUT DISCONNECTION. APART FROM THIS, THIS PROBE SYSTEMATICALLY ABUTS ON THE CANNULA, WHICH MEANS THAT THE SYSTEM HAS TO BE DISCONNECTED IN ORDER TO BE ABLE TO INSERT THE PROBE." THE PATIENT DESATURATED AND WAS DISTRESSED. THE DEVICE WAS CHANGED. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NOT YET RECEIVED.
Patient problems: Discomfort; Low Oxygen Saturation
MAUDE report 12369992 ↗
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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