Ultraflex™ Tracheobronchial M00576550Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 08714729842354), received between Jan 11, 2017 and Jun 4, 2026 — classified as 3 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Activation, Positioning or Separation Problem” (3 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

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryJun 4, 2026Difficult to Remove; Positioning Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ULTRAFLEX TRACHEOBRONCHIAL STENT WAS ATTEMPTED TO BE IMPLANTED TO THE LUNGS TO TREAT A STRICTURE CAUSED BY CANCER DURING A BRONCHOSCOPY PROCEDURE PERFORMED ON (B)(6) 2026. THE ANATOMY OF THE PATIENT WAS TORTUROUS. DURING THE PROCEDURE, WHEN THE SCOPE WAS RETRACTED, THE PHYSICIAN FELT RESISTANCE. UPON INSPECTION THROUGH THE SCOPE, IT WAS OBSERVED THAT THE STENT WAS CAUGHT ON THE ENDOTRACHEAL TUBE. REPORTEDLY, THE STENT WAS DIFFICULT TO BE REMOVED BUT IT WAS EVENTUALLY RETRIEVED BY USING FORCEPS. THE PROCEDURE WAS COMPLETED USING ANOTHER OF THE SAME DEVICE. THERE ARE NO PATIENT COMPLICATIONS REPORTED AS RESULT OF THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25399410 ↗
• MalfunctionOct 16, 2024Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ULTRAFLEX TRACHEOBRONCHIAL DISTAL RELEASE COVERED STENT WAS TO BE IMPLANTED IN THE AIRWAY DURING A BRONCHOSCOPY WITH STENT IMPLANTATION PROCEDURE PERFORMED ON (B)(6) 2024. DURING THE PROCEDURE, THE STENT DEPLOYMENT SUTURE GOT STUCK AND THE STENT COULD NOT BE FULLY DEPLOYED. THE STENT WAS REMOVED FROM THE PATIENT PARTIALLY DEPLOYED AND ANOTHER ULTRAFLEX TRACHEOBRONCHIAL STENT WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20467454 ↗
• MalfunctionJan 5, 2023Activation, Positioning or Separation Problem; Material Twisted/Bent; Activation, Positioning or Separation Problem; Material Twisted/Bent

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2022, THAT AN ULTRAFLEX TRACHEOBRONCHIAL COVERED DISTAL RELEASE STENT WAS TO BE IMPLANTED IN THE BRONCHIAL TREE TO TREAT A STRICTURE DURING A STENT PLACEMENT PROCEDURE PERFORMED ON AN UNKNOWN DATE. PRIOR TO PROCEDURE, WHILE UNPACKING THE ULTRAFLEX TRACHEOBRONCHIAL STENT, IT WAS NOTED THAT THE SHAFT WAS EXTREMELY BENT, AND THE BLACK STENT DEPLOYMENT SUTURE WAS PARTIALLY UNRAVELED. ANOTHER ULTRAFLEX TRACHEOBRONCHIAL STENT WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. NOTE: A PHOTO OF THE COMPLAINT DEVICE OUTSIDE THE PATIENT WAS PROVIDED BY THE COMPLAINANT AND SHOWED THE DELIVERY SHAFT WAS BENT AND THE ULTRAFLEX TRACHEOBRONCHIAL STENT WAS PARTIALLY DEPLOYED ON THE DELIVERY SYSTEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16102019 ↗
• InjuryNov 2, 2020Material Deformation; Positioning Problem; Material Deformation; Positioning Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2020 THAT AN ULTRAFLEX TRACHEOBRONCHIAL COVERED DISTAL RELEASE STENT WAS TO BE IMPLANTED IN THE LUNG TO TREAT A MALIGNANT STRICTURE DURING A BRONCHOSCOPY WITH STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2020. REPORTEDLY, THE PATIENT'S ANATOMY WAS MODERATELY TORTUOUS AND WAS NOT DILATED PRIOR TO STENT PLACEMENT. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE DELIVERY CATHETER KINKED WHEN DEPLOYING THE STENT. REPORTEDLY, AS A RESULT, THE STENT MOVED PROXIMAL AND WAS IN AN INCORRECT LOCATION. THE STENT WAS ATTEMPTED TO BE ADJUSTED WITH FORCEPS BUT WAS UNSUCCESSFUL. REPORTEDLY, THE STENT WAS REMOVED WITH RAT-TOOTH FORCEPS AND THE PROCEDURE WAS COMPLETED WITH ANOTHER ULTRAFLEX TRACHEOBRONCHIAL STENT. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10774764 ↗
• InjuryMay 9, 2019Difficult to Remove; Positioning Problem; Difficult to Remove; Positioning Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2019 THAT AN ULTRAFLEX TRACHEOBRONCHIAL COVERED DISTAL RELEASE STENT WAS TO BE USED TO TREAT A TUMOR IN THE RIGHT MAINSTEM BRONCHUS DURING A BRONCHOSCOPY WITH STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2019. REPORTEDLY, THE PATIENT PRESENTED WITH LATE STAGE LUNG CANCER. TUMOR DEBULKING WAS PERFORMED PRIOR TO STENT PLACEMENT. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE STENT WAS DEPLOYED INSIDE THE PATIENT; HOWEVER, THE STENT WAS DISLODGE WHEN THE PHYSICIAN TRIED TO REMOVE THE DELIVERY SYSTEM. THE STENT WAS REMOVED WITH BIOPSY FORCEPS. THE PHYSICIAN CHOSE TO COMPLETE THE PROCEDURE AT THIS POINT AND NOT PLACE ANY OTHER DEVICE, REPORTEDLY, THE PATIENT WAS SENT FOR CHEMOTHERAPY. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8597077 ↗
• MalfunctionJan 11, 2017Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2016 THAT AN ULTRAFLEX¿ TRACHEOBRONCHIAL DISTAL RELEASE COVERED STENT WAS TO BE USED IN THE LEFT MAIN STEM BRONCHUS DURING A STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2016. REPORTEDLY, PATIENT¿S ANATOMY WAS NOT TORTUOUS AND WAS DILATED PRIOR TO STENT PLACEMENT. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE PHYSICIAN ATTEMPTED TO DEPLOY THE STENT AND WHEN THE DEPLOYMENT SUTURE WAS PULLED, THE DELIVERY SYSTEM BOWED OUT OF THE PATIENT¿S AIRWAY. THE STENT WAS PARTIALLY DEPLOYED WHEN 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 6243276 ↗