Ultraflex™ Tracheobronchial M00576640Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 08714729842446), received between Jun 10, 2020 and Jul 27, 2026 — classified as 3 injuries.

The most frequently reported specific device problem is “Difficult or Delayed Positioning” (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

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryJul 27, 2026Migration

  Boston Scientific Corporation performed a retrospective data analysis on the Ultraflex Tracheobronchial Stent System using the PINC AI Healthcare Database. Patients were identified through records associated with use of the Ultraflex Tracheobronchial Stent System. The Date Review Period ranges from (b)(6) 2023 to (b)(6) 2025. These analyses are being performed as a specific Post Market Clinical Follow up (PMCF) activity to assess the safety and performance of the subject device.The PINC AI Healthcare Database data is de-identified before being transmitted to Boston Scientific; thus, there are significant limitations to Boston Scientific's ability to correlate the data to information previously reported to Boston Scientific. Additionally, Event Date, Event Outcome, and Initial Reporter are not provided in the de-identified data due to the terms of the PINC AI Healthcare Database.Patient Admission Date: (b)(6)2020. Patient Discharge Date: (b)(6) 2020. Displacement of device was observed. The patient underwent an endoscopic removal of an airway device and endoscopic inspection of the trachea and bronchi, and an Ultraflex Tracheobronchial Stent was subsequently placed.Note: IMDFR code

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50002917 ↗
• InjuryMar 17, 2023Use of Device Problem; Positioning Problem; Use of Device Problem; Positioning Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON FEBRUARY 27, 2023, THAT AN ULTRAFLEX TRACHEOBRONCHIAL COVERED DISTAL STENT WAS TO BE IMPLANTED IN THE TRACHEA TO TREAT A 5CM BENIGN TRACHEAL STENOSIS DURING A BRONCHOSCOPY WITH TRACHEAL STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2023. THE PATIENT'S ANATOMY WAS STRUCTURED AT 1.5 CM AND WAS DILATED TO 15 MM. DURING THE PROCEDURE, THE GUIDEWIRE WAS INTRODUCED INTO THE FLEXIBLE BRONCHOSCOPE TO SURVEY THE AIRWAY. THE BRONCHOSCOPE WAS THEN REMOVED, AND THE STENT WAS BACKLOADED OVER THE GUIDEWIRE. UPON DEPLOYMENT, THE ULTRAFLEX TRACHEOBRONCHIAL STENT BUNCHED UP IN THE LMA (LARYNGEAL MASK AIRWAY) AND WAS DEPLOYED INSIDE THE LMA. THE ULTRAFLEX TRACHEOBRONCHIAL STENT WAS REMOVED FROM THE PATIENT TOGETHER WITH THE LMA. SUBSEQUENTLY, EDEMA/ SWELLING AND AIRWAY DESATURATION WERE OBSERVED; THEREFORE, AIRWAY RE-SATURATION AND DECOMPRESSION WAS PERFORMED. THE PROCEDURE WAS NOT COMPLETED, AND A NEW PROCEDURE FOR STENT PLACEMENT WAS SCHEDULED ON (B)(6) 2023. THE PATIENT CONDITION AFTER THE PROCEDURE WAS EXPECTED TO FULLY RECOVER.

  Patient problems: Insufficient Information; Respiratory Insufficiency; Swelling/ Edema

  MAUDE report 16566599 ↗
• InjuryJun 10, 2020Difficult or Delayed Positioning; Material Deformation; Difficult or Delayed Positioning; Material Deformation

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ULTRAFLEX TRACHEOBRONCHIAL COVERED DISTAL RELEASE STENT WAS TO BE USED TO TREAT AN APPROXIMATELY 2 CM MALIGNANT PULMONOLOGICAL OBSTRUCTION DURING A BRONCHOSCOPY WITH STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2020. REPORTEDLY, THE PATIENT'S ANATOMY WAS TIGHT AND WAS DILATED PRIOR TO STENT PLACEMENT. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, RESISTANCE WAS FELT DURING THE ATTEMPT DEPLOYMENT. FORCE WAS APPLIED IN PULLING THE STENT DEPLOYMENT SUTURE, BUT THE STENT FAILED TO OPEN. THE DEVICE WAS REMOVED FROM THE PATIENT. REPORTEDLY, THE PHYSICIAN ATTEMPTED TO DEPLOY THE STENT OUTSIDE THE PATIENT AND THE FIRST KNOT LOOP WAS OPENED. THE STENT WAS REINTRODUCED INSIDE THE PATIENT AND THE STENT WAS ABLE TO BE DEPLOYED. HOWEVER, THE PHYSICIAN NOTICED THAT THE STENT WAS BUCKLED AND WHEN THE STENT WAS PULLED, IT GOT COILED. THE STENT WAS REMOVED WITH RAT TOOTH FORCEPS AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. 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 10140080 ↗