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Ballard* Closed Suction System 93823Recalls & reported problems

Avanos Medical, Inc. · BALLARD* Closed Suction Catheter, Y-Adapter, Neonatal/Pediatric · Class 1

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 00609038938233), received between Jul 20, 2023 and Jul 20, 2023 — classified as 1 malfunction.

The most frequently reported specific device problem is “Break” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Device problems

  • Break1

Patient problems

  • Foreign Body In Patient1

Recent adverse event reports

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

  • MalfunctionJul 20, 2023Break; Break

    IT WAS REPORTED, DURING USE OF THE CLOSED SUCTION CATHETER (CSC) THE NEONATAL INTENSIVE CARE UNIT (NICU) BABY RETAINED "A FOREIGN BODY". THERE WAS NO REPORTED INJURY; IT IS UNKNOWN IF ANY MEDICAL INTERVENTION WAS REQUIRED.

    Patient problems: Foreign Body In Patient

    MAUDE report 17368029 ↗

Other CATHETERS, SUCTION, TRACHEOBRONCHIAL devices

All CATHETERS, SUCTION, TRACHEOBRONCHIAL devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.