Ultraflex™ Tracheobronchial M00576470Recalls & 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 08714729837831), received between Nov 22, 2016 and Nov 22, 2016 — classified as 1 malfunction.
The most frequently reported specific device problem is “Activation, Positioning or Separation 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
- Activation, Positioning or Separation Problem1
Patient problems
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionNov 22, 2016Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem
NOTE: THIS MANUFACTURER REPORT PERTAINS TO ONE OF TWO DEVICES USED IN THE SAME PROCEDURE. REFER TO MANUFACTURER REPORT # 3005099803-2016-03497 AND 3005099803-2016-03597 FOR THE OTHER ASSOCIATED DEVICE INFORMATION. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON NOVEMBER 1, 2016 THAT TWO ULTRAFLEX TRACHEOBRONCHIAL STENTS WERE TO BE USED IN THE RIGHT MAINSTEM BRONCHUS DURING A BRONCHOSCOPY WITH STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2016. ACCORDING TO THE COMPLAINANT, THE PHYSICIAN STARTED DEPLOYING THE FIRST ULTRAFLEX TRACHEOBRONCHIAL STENT (THE SUBJECT TO MFR REPORT # 3005099803-2016-03497) WHEN THE STENT COULD NOT BE FULLY DEPLOYED AND THE CATHETER BOWED. THE PARTIALLY DEPLOYED STENT WAS REMOVED FROM THE PATIENT. THE PHYSICIAN USED A SECOND ULTRAFLEX TRACHEOBRONCHIAL STENT (THE SUBJECT TO MFR REPORT # 3005099803-2016-03597); HOWEVER, THE STENT STILL COULD NOT BE FULLY DEPLOYED. DURING REMOVAL OF THE PARTIALLY DEPLOYED STENT, THE STENT SYSTEM GOT STUCK IN THE PATIENT¿S ENDOTRACHEAL TUBE. THE PHYSICIAN REMOVED THE ENDOTRACHEAL TUBE AND REINTUBATED THE PATIENT. REPORTEDLY, ANOTHER ULTRAFLEX TRACHEOBRONCHIAL STENT WAS IMPLANTED ONE WEEK POST-PROCEDURE. THERE WERE NO PATIENT
Patient problems: No Consequences Or Impact To Patient
MAUDE report 6122131 ↗
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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