Ballard* Turbo-Cleaning Closed Suction System 98265Recalls & reported problems
Avanos Medical, Inc. · Turbo-Cleaning Closed Suction System for Adults, DSE, MDI · 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
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00609038982656), received between Jul 14, 2020 and Jul 14, 2020 — classified as 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
Patient problems
- Bradycardia1
- Hypoxia1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 14, 2020Disconnection; Disconnection
IT WAS REPORTED THAT DURING THE TIME PERIOD WHERE THE HOSPITAL WAS TREATING COVID PATIENTS, THERE WAS AN ISSUE WITH DISCONNECTION BETWEEN THE CLOSED SUCTION SYSTEM AND THE TWINSTAR 90 DRAËGER PATIENT FILTER REFERENCE (B)(4). THE ALLEGED RESULT OF THIS DISCONNECTION WAS HYPOXIC BRADYCARDIA. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NOT YET RECEIVED.
Patient problems: Bradycardia; Hypoxia
MAUDE report 10272198 ↗
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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