Ultraflex™ Tracheobronchial M00576300Recalls & 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
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 08714729837688), received between Aug 6, 2021 and Aug 6, 2021 — classified as 1 malfunction.
The most frequently reported specific device problem is “Difficult to Remove” (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
- Difficult to Remove1
- Positioning Problem1
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.
MalfunctionAug 6, 2021Difficult to Remove; Positioning Problem; Difficult to Remove; Positioning Problem
NOTE: THIS REPORT PERTAINS TO ONE OF THE TWO DEVICES USED DURING THE SAME PROCEDURE. REFER TO MANUFACTURING REPORT# 3005099803-2021-03968 FOR THE ASSOCIATED DEVICE INFORMATION. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2021 THAT AN ULTRAFLEX TRACHEOBRONCHIAL UNCOVERED PROXIMAL RELEASE STENT WAS TO BE IMPLANTED IN THE RIGHT MIDDLE LOBE (RML) TO TREAT A LUNG STRICTURE AND TO OPEN A COLLAPSED AIRWAY DURING AN AIRWAY STENT CASE PROCEDURE PERFORMED ON (B)(6) 2021. REPORTEDLY, THE PATIENT'S ANATOMY APPEARED TIGHT AND WAS NOT DILATED PRIOR TO STENT PLACEMENT. DURING THE PROCEDURE, THE STENT WAS DEPLOYED SUCCESSFULLY; HOWEVER, UNDER DIRECT ENDOSCOPIC VISUALIZATION, IT WAS OBSERVED THAT THE ULTRAFLEX TRACHEOBRONCHIAL STENT (THE SUBJECT OF MFR. REPORT# 3005099803-2021-03968) WAS DISLODGED OUT OF ITS CORRECT LOCATION WHEN THE DELIVERY SYSTEM WAS ATTEMPTED TO BE REMOVED. THE PHYSICIAN ATTEMPTED TO READJUST THE STENT INTO THE CORRECT POSITION USING FORCEPS AND A BALLOON; HOWEVER, THE ATTEMPT WAS UNSUCCESSFUL. THE STENT WAS REMOVED FROM THE PATIENT WITH FORCEPS AND A 10X30 ULTRAFLEX TRACHEOBRONCHIAL STENT (THE SUBJECT OF THIS REPORT) WAS IMPLANTED; HOWEVER, THE SAME PROBLEM OCCU
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12288573 ↗
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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