Bronchial Thermoplasty System
FDA adverse event reports and recall history for bronchial thermoplasty system (product code OOY), from the public MAUDE/AEMS corpus and the live FDA recall database.
- Total reports
- 500
- Deaths
- 3
- Injuries
- 483
- Malfunctions
- 14
Reports per year
Source: FDA adverse event reports by year received, 2010–2023. Reporting paused during the 2026 MAUDE-to-AEMS transition and has since resumed.
Recent recalls
- 2013-07-17TerminatedError in labeling
Alair Bronchial Thermoplasty Catheter, Bronchial Thermoplasty System; Material Number: M005ATS25010, Catalog Number: ATS 2-5. Product is manufactured and distributed by Boston Scientific Corporation (BSC), Sunnyvale, CA The Alair Bronchial Thermoplasty System (including the Alair Bronchial Thermoplasty Catheter) is indicated for the treatment of severe persistent asthma in patients 18 years and older whose asthma is not well controlled with inhaled corticosteroids and long acting beta agonists.
Boston Scientific has discovered an inconsistent "Use By" expiration date on a single lot/batch of Alair Bronchial Thermoplasty Catheters. The expiration date indicated on the inner tray, 2012-04, is incorrect. The correct expiration date is 2014-04 as indicated on the outer box label.
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