Skip to content

BALLARD* 2123Recalls & reported problems

Avanos Medical, Inc. · BALLARD* CS Adult, 12 Fr, Elbow with Caps · 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 00609038000183), received between Feb 27, 2023 and Feb 27, 2023 — classified as 1 malfunction.

The most frequently reported specific device problem is “Gas/Air Leak” (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

  • Gas/Air Leak1

Patient problems

  • Insufficient Information1

Recent adverse event reports

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

  • MalfunctionFeb 27, 2023Gas/Air Leak; Gas/Air Leak

    IT WAS REPORTED " LAST NIGHT AT 3AM WE HAD LOW PRESSURE ALARMS AND COULD NOT FIGURE OUT WHY, BUT WE MANAGED TO GET THE ALARM TO STOP. THIS MORNING MY NURSE HEARD SOME AIR LEAKING FROM THE BOTTOM SECTION WHERE THE VALVE IS LOCATED. WE WERE LOSING PRESSURE FROM THERE. SHE PUSHED IT UP AND THE LEAK STOPPED." THERE WAS NO REPORTED INJURY.

    Patient problems: Insufficient Information

    MAUDE report 16448422 ↗

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.