AEROmini® 00884450307922Recalls & reported problems
Merit Medical Systems, Inc. · Class 2 · Implant
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 00884450307922), received between Oct 3, 2019 and Oct 3, 2019 — classified as 1 injury.
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
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Airway Obstruction1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryOct 3, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE ACCOUNT ALLEGES THAT ON (B)(6) 2019, POST LEFT UPPER LOBE TRACHEOBRONCHIAL STENT PLACEMENT PROCEDURE, THE PATIENT WAS DOING FINE. ON (B)(6) 2019, THE PATIENT'S OXYGEN SATURATIONS DROPPED SIGNIFICANTLY. THE PATIENT WAS TRANSFERRED TO ICU AND ADMINISTERED OXYGEN VIA HIGH FLOW NASAL CANNULA CONSEQUENTLY CORRECTING THE PATIENT'S LOW O2 SATURATION EVENT. THE PHYSICIAN WAS SUSPICIOUS OF A POSSIBLE TRACHEAL BRONCHIAL AIRWAY OBSTRUCTION, SO THE PATIENT WAS TRANSFERRED TO A SURGICAL PROCEDURE ROOM FOR VERIFICATION. THE STENT WAS OBSTRUCTED WITH MUCOUS SECRETIONS, SO THE TRACHEOBRONCHIAL STENT WAS REMOVED BY THE PHYSICIAN. THE STENT REMOVAL PROCEDURE WAS CONSIDERED UNREMARKABLE BY THE PHYSICIAN. THE PATIENT WAS TRANSFERRED BACK TO ICU STILL INTUBATED FOR RECOVERY.
Patient problems: Airway Obstruction
MAUDE report 9151977 ↗
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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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