Ballard* Closed Suction System 99335Recalls & reported problems
Avanos Medical, Inc. · BALLARD* Closed Suction Catheter, Elbow, Neonatal/Pediatric · 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 00609038993355), received between Feb 13, 2024 and Apr 18, 2024 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Difficult to Advance” (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
- Difficult to Advance1
- Inadequacy of Device Shape and/or Size1
- Physical Resistance/Sticking1
Patient problems
- Insufficient Information1
- 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.
MalfunctionApr 18, 2024Inadequacy of Device Shape and/or Size; Difficult to Advance; Inadequacy of Device Shape and/or Size; Difficult to Advance
IT WAS REPORTED, THE CATHETER HAD A CURVE AND WAS DIFFICULT TO ADVANCE; THE CATHETER WAS CHANGED AND THERE WERE NO FURTHER PROBLEMS. THERE WAS NO REPORTED INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19139702 ↗MalfunctionFeb 13, 2024Physical Resistance/Sticking; Physical Resistance/Sticking
IT WAS REPORTED, THE BUTTON ON THE CONTROL VALVE DID NOT RETURN, WHILE IN USE. THE DEVICE WAS IN PLACE FOR A 24-HOUR PERIOD, IT WAS REPLACED WITH A NEW PRODUCT. THERE WAS NO REPORTED INJURY.
Patient problems: Insufficient Information
MAUDE report 18695984 ↗
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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