Ballard* Closed Suction System for Adults 99351Recalls & reported problems
Avanos Medical, Inc. · BALLARD* Closed Suction Catheter, Double Swivel Elbow · Class 1
All models of Ballard* Closed Suction System for Adults (17)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00609038993515), received between Nov 17, 2024 and May 23, 2025 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Inflation Problem” (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.
Reports received per month
Most reported problems
Device problems
- Inflation Problem2
- Infusion or Flow Problem1
Patient problems
- Insufficient Information2
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 23, 2025Infusion or Flow Problem; Infusion or Flow Problem
IT WAS REPORTED, THE SLEEVE DID NOT INFLATE; THERE WAS NO REPORTED INJURY TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22081832 ↗MalfunctionDec 10, 2024Inflation Problem; Inflation Problem
IT WAS REPORTED, THAT AFTER TRACHEAL SUCTION, AIR ENTERED INTO THE SLEEVE AND IT INFLATED. THE CATHETER BECAME DIFFICULT TO INSERT.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 20897812 ↗MalfunctionNov 17, 2024Inflation Problem; Inflation Problem
IT WAS REPORTED, AFTER TRACHEAL ASPIRATION, THE NURSE NOTICED THAT THE SLEEVE WAS INFLATED, THE DEVICE WAS IMMEDIATELY REPLACED WITH A NEW PRODUCT; THERE WAS NO REPORTED INJURY TO THE PATIENT.
Patient problems: Insufficient Information
MAUDE report 20702903 ↗
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.
How reports and recalls are matched · Editorial policy · Report an error on this page