Skip to content

Ballard* Closed Suction System for Adults 98295Recalls & reported problems

Avanos Medical, Inc. · BALLARD* Closed Suction Catheter, T-Piece · 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
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 00609038982953), received between Jul 20, 2020 and Jul 20, 2020 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Loose or Intermittent Connection” (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.

Most reported problems

Device problems

  • Loose or Intermittent Connection2

Patient problems

  • No Consequences Or Impact To Patient2

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

  • MalfunctionJul 20, 2020Loose or Intermittent Connection; Loose or Intermittent Connection

    AVANOS MEDICAL INC. RECEIVED A SINGLE REPORT THAT REFERENCED TWO DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS. THIS IS THE SECOND OF TWO REPORTS. REFER TO 8030647-2020-00049 FOR THE FIRST REPORT. IT WAS REPORTED THAT "THE MOUNT IS NOT CONNECTING TO THE ETT [ENDOTRACHEAL TUBE] WITH OR WITHOUT FLEX CONNECTOR IN PACKET (OR SIMILAR CONNECTOR FROM OFF THE SHELF). NOT OFFERING A SEAL CAUSING DISRUPTION TO VENTILATION PARAMETERS WITH PRESSURES FALLING." NO ILL EFFECTS FROM THE CLOSED SUCTION CATHETER; THIS WAS REMOVED AND A 14FR [FRENCH] USED WITH NO ISSUES.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 10295816 ↗
  • MalfunctionJul 20, 2020Loose or Intermittent Connection; Loose or Intermittent Connection

    AVANOS MEDICAL INC. RECEIVED A SINGLE REPORT THAT REFERENCED TWO DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS. THIS IS THE FIRST OF TWO REPORTS. REFER TO 8030647-2020-00050 FOR THE SECOND REPORT. IT WAS REPORTED THAT "THE MOUNT IS NOT CONNECTING TO THE ETT [ENDOTRACHEAL TUBE] WITH OR WITHOUT FLEX CONNECTOR IN PACKET (OR SIMILAR CONNECTOR FROM OFF THE SHELF). NOT OFFERING A SEAL CAUSING DISRUPTION TO VENTILATION PARAMETERS WITH PRESSURES FALLING." NO ILL EFFECTS FROM THE CLOSED SUCTION CATHETER; THIS WAS REMOVED AND A 14FR [FRENCH] USED WITH NO ISSUES.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 10295808 ↗

Other CATHETERS, SUCTION, TRACHEOBRONCHIAL devices

All CATHETERS, SUCTION, TRACHEOBRONCHIAL devices →

Sources and updates

How reports and recalls are matched · Editorial policy · Report an error on this page