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Ballard* Closed Suction System 93895Recalls & reported problems

Avanos Medical, Inc. · BALLARD* Closed Suction Catheter, Y-Adapter, 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
1
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00609038938950), received between Apr 10, 2023 and Apr 10, 2023 — classified as 1 malfunction.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (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.

Most reported problems

Device problems

  • Detachment of Device or Device Component1
  • Gas/Air Leak1
  • Material Split, Cut or Torn1

Patient problems

  • Cough1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • MalfunctionApr 10, 2023Detachment of Device or Device Component; Gas/Air Leak; Material Split, Cut or Torn; Detachment of Device or Device Component; Gas/Air Leak; Material Split, Cut or Torn

    IT WAS REPORTED THAT THE PLASTIC SLEEVE AROUND THE SUCTION CATHETER RIPS. THE CATHETER WAS OPEN TO TOUCH, AND FELL OUT OF HUB WHICH CREATED A LARGE LEAK. SECRETIONS WERE COUGHED UP THROUGH HOLE. NO INJURY OR MEDICAL INTERVENTIONS REPORTED.

    Patient problems: Cough

    MAUDE report 16706638 ↗

Other CATHETERS, SUCTION, TRACHEOBRONCHIAL devices

All CATHETERS, SUCTION, TRACHEOBRONCHIAL devices →

Sources and updates

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