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Ballard* Closed Suction System 93832Recalls & reported problems

Avanos Medical, Inc. · BALLARD* Closed Suction Catheter, Elbow, 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 00609038938325), received between Jun 9, 2023 and Jun 9, 2023 — classified as 1 malfunction.

The most frequently reported specific device problem is “Material Rupture” (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

  • Material Rupture1

Patient problems

  • Respiratory Insufficiency1

Recent adverse event reports

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

  • MalfunctionJun 9, 2023Material Rupture; Material Rupture

    IT WAS REPORTED THE "PATIENT [WAS] DECOMPENSATING, UNCLEAR IF PATIENT STATUS RELATED TO EQUIPMENT FAILURE. REGISTERED NURSE (RN) DISCOVERED BALLARD OVERWRAP WAS TORN BEFORE ATTEMPTING TO SUCTION PATIENT AND STOPPED RESPIRATORY THERAPIST (RT) REPLACED EQUIPMENT." ADDITIONAL INFORMATION RECEIVED 16-MAY-2023 STATES THE CATHETER WAS IN USE FOR "SEVERAL DAYS" AND THE CURRENT STATUS OF PATIENT IS "STABLE."

    Patient problems: Respiratory Insufficiency

    MAUDE report 17100573 ↗

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.