Ballard* Mini-BAL Sampling Catheter 11139Recalls & reported problems
Avanos Medical, Inc. · BALLARD* Mini-BAL Sampling Catheter · Class 1
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00609038111391), received between Sep 21, 2021 and Sep 21, 2021 — classified as 1 injury.
The most frequently reported specific device problem is “Material Fragmentation” (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 18, 2026.
Most reported problems
Device problems
- Material Fragmentation1
Patient problems
- Bradycardia1
- 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.
InjurySep 21, 2021Material Fragmentation; Material Fragmentation
IT WAS REPORTED THAT THE PATIENT WAS UNDERGOING A MINI BAL [ALVEOLAR LAVAGE] PROCEDURE ON THE RIGHT LUNG WHEN THE PATIENT'S HEART RATE DROPPED AND VENTILATOR VOLUMES WOULD NOT RETURN TO PREPROCEDURAL VOLUMES. ET [ENDOTRACHEAL] TUBE HAD TO BE REMOVED FROM PATIENT'S AIRWAY. AT THAT TIME THE CSC [CLOSED SUCTION CATHETER] TIP WAS DETERMINED TO BE MISSING. IT WAS LATER LOCATED AND REMOVED. ACCORDING TO THE USER FACILITY, "FOLLOWED PROCEDURE GUIDELINES, 100% FIO2 [OXYGEN CONCENTRATION] SXN [SUCTION] PRIOR, TURN SUCTION PRESSURE DOWN TO 60. ADVANCED MINI BAL CATHETER INSIDE PT [PATIENT] ETT [ENDOTRACHEAL TUBE], TILL NUMBERS MATCHED. ADVANCING INNER CATHETER WITH INSPIRATION. DURING INSTILLATION 30ML OF SALINE WAS ADVANCED TO R [RIGHT] SIDE, TURNED STOPCOCK WITH NO RETURNED SPUTUM, EXTRA PRESSURE NOTED. PT STARTED TO BRADY TO 51. VOLUMES ON VENTILATOR NOT RETURNING. IMMEDIATELY WITHDREW ETT, ALLOWING PT TO RECOVER. DURING THIS TIME WITH CATHETER WITHDRAWN NOTED TIP OF CATHETER MISSING. FOUND MISSING CATHETER TIP PULLED BACK INTO CATHETER." ADDITIONAL INFORMATION RECEIVED 02-SEP-2021 INDICATED THE MINI BAL PROCEDURE WAS PERFORMED FOR BRONCHIAL SAMPLING. NO INTERVENTIONS WERE NEEDED; THE PAT
Patient problems: Bradycardia; Foreign Body In Patient
MAUDE report 12509684 ↗
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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