AERO® 00884450030738Recalls & reported problems
Merit Medical Systems, Inc. · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00884450030738), received between Oct 15, 2020 and Jan 6, 2022 — classified as 2 injuries.
The most frequently reported specific device problem is “Infusion or Flow Problem” (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
- Infusion or Flow Problem1
- Partial Blockage1
- Unclear Information1
Patient problems
- Airway Obstruction1
- Respiratory Insufficiency1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryJan 6, 2022Partial Blockage; Infusion or Flow Problem; Partial Blockage; Infusion or Flow Problem
THE ACCOUNT ALLEGES THAT ON (B)(6) 2021 A TRACHEOBRONCHIAL STENT WAS IMPLANTED IN RESPIRATORY SURGERY. ON (B)(6) 2021, THE PATIENT WAS DISCHARGED FROM THE HOSPITAL IN GOOD POSTOPERATIVE CONDITION. ON (B)(6) 2021, THE PATIENT HAD TROUBLE BREATHING. ON (B)(6) 2021, A CT SCAN WAS PERFORMED DURING FOLLOW UP EXAMINATION. IT WAS NOTED THAT SPUTUM HAD ACCUMULATED WITHIN THE STENT. ON (B)(6) 2021, THE PATIENT WAS ADMITTED AND UNDERWENT AN INTERVENTIONAL PROCEDURE TO REMOVE THE SPUTUM ENDOSCOPICALLY WITH A FLEXIBLE BRONCHOSCOPE. CHEMOTHERAPY AND THE OTHER TREATMENTS WERE PERFORMED ON THE PATIENT. ON (B)(6) 2021, BRONCHOSCOPY WAS RE-PERFORMED, AND IT WAS CONFIRMED THAT THE ACCUMULATION HAD IMPROVED. ON (B)(6) 2021, THE PATIENT WAS DISCHARGED. ON (B)(6) 2021 THE PATIENT EXPIRED DUE TO THE PROGRESSION OF THE PATIENT'S DISEASE.
Patient problems: Respiratory Insufficiency
MAUDE report 13181571 ↗InjuryOct 15, 2020Unclear Information; Unclear Information
A RESEARCH PAPER IDENTIFIED A CASE REPORT THAT ALLEGES A TRACHEOBRONCHIAL STENT, IMPLANTED IN (B)(6) 2018 WITHIN THE PATIENT'S LEFT MAIN BRONCHUS, HAD TOTALLY OCCLUDED WITH GRANULATION TISSUE. THE STENT WAS REMOVED, AND THE PATIENT HAS UNDERGONE FREQUENT ABLATION PROCEDURES.
Patient problems: Airway Obstruction
MAUDE report 10687300 ↗
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- WALLSTENT® Endoprosthesis H965404130Boston Scientific Corporation · Prosthesis, tracheal, expandable11 reports
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- iCAST 85414Atrium Medical Corporation · Prosthesis, tracheal, expandable10 reports
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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