Ballard* Closed Suction System 99331Recalls & reported problems
Avanos Medical, Inc. · BALLARD* Closed Suction Catheter, Elbow, Neonatal/Pediatric · Class 1
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00609038993317), received between Mar 11, 2024 and Feb 11, 2025 — classified as 4 malfunctions.
The most frequently reported specific device problem is “Backflow” (3 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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Backflow3
- Loose or Intermittent Connection1
Patient problems
- Insufficient Information3
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 11, 2025Loose or Intermittent Connection; Loose or Intermittent Connection
IT WAS REPORTED, THE ATTACHED Y ADAPTER DISCONNECTED DURING PATIENT USE WHICH CAUSED A LEAK. IT IS UNKNOWN HOW LONG IT WAS DISCONNECTED; THERE WAS NO REPORTED INJURY.
Patient problems: Insufficient Information
MAUDE report 21360444 ↗MalfunctionMar 11, 2024Backflow; Backflow
AVANOS MEDICAL INC. RECEIVED A SINGLE REPORT THAT REFERENCED TWO DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING THE SAME PATIENT. THIS IS THE SECOND OF TWO REPORTS. REFER TO 8030647-2024-00016 FOR THE FIRST REPORT. IT WAS REPORTED, DURING TRACHEAL SUCTION, ABNORMAL EXPANSION OF THE SLEEVE OF THE PRODUCT OCCURRED, ITS USE WAS DISCONTINUED; THERE WAS NO REPORTED INJURY.
Patient problems: Insufficient Information
MAUDE report 18882389 ↗MalfunctionMar 11, 2024Backflow; Backflow
AVANOS MEDICAL INC. RECEIVED A SINGLE REPORT THAT REFERENCED TWO DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING THE SAME PATIENT. THIS IS THE FIRST OF TWO REPORTS. REFER TO 8030647-2024-00017 FOR THE SECOND REPORT. IT WAS REPORTED, DURING TRACHEAL SUCTION, ABNORMAL EXPANSION OF THE SLEEVE OF THE PRODUCT OCCURRED, ITS USE WAS DISCONTINUED; THERE WAS NO REPORTED INJURY.
Patient problems: Insufficient Information
MAUDE report 18882387 ↗MalfunctionMar 11, 2024Backflow; Backflow
IT WAS REPORTED, DURING TRACHEAL SUCTION, ABNORMAL EXPANSION OF THE SLEEVE OF THE PRODUCT WAS CONFIRMED AND ITS USE WAS DISCONTINUED. THERE WAS NO REPORTED INJURY TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18874349 ↗
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: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.