Ultraflex™ Tracheobronchial M00576330Recalls & reported problems
Boston Scientific Corporation · Distal Release Stent System · Class 2 · Implant
All models of Ultraflex Tracheobronchial (25)
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 08714729837718), received between Jul 27, 2026 and Jul 27, 2026 — 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.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Hemoptysis1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryJul 27, 2026Adverse Event Without Identified Device or Use Problem
Boston Scientific Corporation performed a retrospective data analysis on the Ultraflex Tracheobronchial Stent System using the PINC AI Healthcare Database. Patients were identified through records associated with use of the Ultraflex Tracheobronchial Stent System. The Date Review Period ranges from January 2023 to December 2025. These analyses are being performed as a specific Post Market Clinical Follow up (PMCF) activity to assess the safety and performance of the subject device.The PINC AI Healthcare Database data is de-identified before being transmitted to Boston Scientific; thus, there are significant limitations to Boston Scientific's ability to correlate the data to information previously reported to Boston Scientific. Additionally, Event Date, Event Outcome, and Initial Reporter are not provided in the de-identified data due to the terms of the PINC AI Healthcare Database.Patient Admission Date: April 21, 2022. Patient Discharge Date: August 31, 2022. Adverse Event including Hemoptysis. The patient underwent endoscopic removal of an intraluminal device from the tracheobronchial tree, followed by endoscopic repair of the right main bronchus and an Ultraflex Tracheobronchial
Patient problems: Hemoptysis
MAUDE report 50002889 ↗
Other Prosthesis, tracheal, expandable devices
- iCAST 85453Atrium Medical Corporation · Prosthesis, tracheal, expandable43 reports
- iCAST 85419Atrium Medical Corporation · Prosthesis, tracheal, expandable13 reports
- WALLSTENT™ BILIARY H965430500Boston Scientific Corporation · Prosthesis, tracheal, expandable13 reports
- iCAST 85445Atrium Medical Corporation · Prosthesis, tracheal, expandable12 reports
- iCAST 85416Atrium Medical Corporation · Prosthesis, tracheal, expandable12 reports
- WALLSTENT® Endoprosthesis H965404130Boston Scientific Corporation · Prosthesis, tracheal, expandable11 reports
- iCAST 85455Atrium Medical Corporation · Prosthesis, tracheal, expandable11 reports
- 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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