Ballard* Closed Suction System 198-4JRecalls & reported problems
Avanos Medical, Inc. · Class 1
All models of Ballard* Closed Suction System (30)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00609038993188), received between Apr 26, 2024 and Jun 25, 2024 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Crack” (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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Crack1
- Material Integrity Problem1
Patient problems
- Insufficient Information2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 25, 2024Material Integrity Problem; Material Integrity Problem
IT WAS REPORTED THE Y-ADAPTOR BROKE DURING USE, [THE DEVICE] WAS REPLACED; THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: Insufficient Information
MAUDE report 19604508 ↗MalfunctionApr 26, 2024Crack; Crack
PER GOOGLE TRANSLATION: IT WAS REPORTED, "I FOUND A CRACK DURING SUCTION THAT WAS NOT IN AT THE TIME OF INSTALLATION". IT WAS ADDITIONALLY REPORTED, ACCORDING TO THE NURSE IN CHARGE OF THE NEONATAL INTENSIVE CARE UNIT (NICU), IT MAY HAVE CRACKED BECAUSE IT WAS PRESSED TOO HARD WHEN IT WAS INSTALLED. THERE WAS NO REPORTED INJURY.
Patient problems: Insufficient Information
MAUDE report 19197555 ↗
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
- Medline DYNCPDS14Medline Industries, Inc. · CATHETERS, SUCTION, TRACHEOBRONCHIAL1 recall16 reports
- Ballard* Turbo-Cleaning Closed Suction System 98965Avanos Medical, 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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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