Ultraflex™ Tracheobronchial M00576440Recalls & reported problems
Boston Scientific Corporation · Proximal 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
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 08714729837800), received between Jul 13, 2022 and Jul 13, 2022 — classified as 1 malfunction.
The most frequently reported specific device problem is “Positioning Failure” (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
- Positioning Failure1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 13, 2022Positioning Failure; Positioning Failure
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON JUNE 16, 2022 THAT AN ULTRAFLEX TRACHEOBRONCHIAL UNCOVERED PROXIMAL RELEASE STENT WAS TO BE IMPLANTED TO TREAT A MALIGNANT STRICTURE IN THE LUNGS DUE TO CANCER DURING A BRONCHOSCOPY WITH STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2022. DURING THE PROCEDURE, THE PHYSICIAN PULLED THE DEPLOYMENT SUTURE BUT THE ULTRAFLEX STENT DID NOT DEPLOY. THE STENT WAS REMOVED FROM THE PATIENT AND THE PROCEDURE WAS NOT COMPLETED. THE PATIENT WAS SCHEDULED FOR ANOTHER STENT PLACEMENT; HOWEVER, THE EXACT DATE IS UNKNOWN. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT THIS EVENT. NOTE: NO FURTHER INFORMATION HAS BEEN OBTAINED DESPITE GOOD FAITH EFFORTS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14999193 ↗
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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