Ultraflex™ Tracheobronchial M00576480Recalls & 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
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 08714729837848), received between Nov 28, 2016 and May 4, 2017 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Activation, Positioning or Separation Problem” (2 reports).
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
- Activation, Positioning or Separation Problem2
Patient problems
- No Consequences Or Impact To Patient2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 4, 2017Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2017 THAT AN ULTRAFLEX TRACHEOBRONCHIAL PROXIMAL RELEASE UNCOVERED STENT WAS TO BE USED IN THE RIGHT LUNG TO TREAT A MALIGNANT EXTRINSIC COMPRESSION OF THE RIGHT BRONCHUS DURING A BRONCHOSCOPY WITH AIRWAY STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2017. REPORTEDLY, THE PATIENT'S ANATOMY WAS DILATED PRIOR TO STENT PLACEMENT PROCEDURE. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE PHYSICIAN STARTED DEPLOYING THE STENT WHEN THE DEPLOYMENT SUTURE GOT STUCK. THE PARTIALLY DEPLOYED STENT WAS REMOVED FROM THE PATIENT AND THE PROCEDURE WAS COMPLETED WITH ANOTHER ULTRAFLEX TRACHEOBRONCHIAL STENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE FINE.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 6546031 ↗MalfunctionNov 28, 2016Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem
NOTE: THIS REPORT PERTAINS TO ONE OF TWO DEVICES USED DURING THE SAME PROCEDURE. REFER TO MANUFACTURER REPORT 3005099803-2016-03620 AND MANUFACTURER REPORT 3005099803-2016-03621 FOR THE ASSOCIATED DEVICE INFORMATION. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON NOVEMBER 03, 2016 THAT TWO ULTRAFLEX TRACHEOBRONCHIAL STENTS WERE TO BE USED IN THE LUNGS TO TREAT A MALIGNANT STRICTURE DURING A STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2016. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, BOTH STENTS WOULD NOT FULLY DEPLOY. THE PARTIALLY DEPLOYED STENTS WERE REMOVED FROM THE PATIENT AND THE PROCEDURE WAS COMPLETED WITH ANOTHER ULTRAFLEX TRACHEOBRONCHIAL STENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE STABLE.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 6130290 ↗
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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