Ultraflex™ Tracheobronchial M00576580Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 08714729842385), received between May 9, 2019 and Jul 27, 2026 — classified as 3 injuries, 1 malfunction.

The most frequently reported specific device problem is “Material Deformation” (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

Recent adverse event reports

The 4 most recent of 4 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)2022. Patient Discharge Date: (b)(6) 2023. Displacement of device was observed. The patient underwent endoscopic removal of an intraluminal device from the trachea and a change of the endotracheal tube. The patient subsequently underwent an endoscopic removal of an intraluminal devi

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50002890 ↗
• MalfunctionMar 5, 2024Activation, Positioning or Separation Problem; Detachment of Device or Device Component; Material Deformation; Activation, Positioning or Separation Problem; Detachment of Device or Device Component; Material Deformation

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ULTRAFLEX TRACHEOBRONCHIAL DISTAL RELEASE STENT WAS TO BE IMPLANTED IN THE AIRWAY FOR PALLIATIVE TREATMENT DURING A TRACHEOBRONCHIAL (TB) STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2024. THE PATIENT'S ANATOMY WAS TORTUOUS AND WAS NOT DILATED PRIOR TO STENT PLACEMENT. DURING THE PROCEDURE, THE STENT DID NOT DEPLOY CORRECTLY. THE STENT WAS REMOVED FROM THE PATIENT, AND A DIFFERENT STENT WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. NOTE: A REVIEW OF THE PROVIDED PHOTO OF THE COMPLAINT DEVICE REVEALED THAT THE STENT WAS PARTIALLY DEPLOYED ON THE DELIVERY SYSTEM, THE SHAFT APPEARED KINKED, AND THE TIP WAS NOTED TO BE DETACHED. ***ADDITIONAL INFORMATION RECEIVED ON MARCH 19, 2024*** IN THE PHYSICIAN'S ASSESSMENT, THE TIP OF THE DEVICE WAS DETACHED OUTSIDE THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18841667 ↗
• InjuryFeb 27, 2023Material Deformation; Positioning Problem; Material Deformation; Positioning Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2023, THAT AN ULTRAFLEX TRACHEOBRONCHIAL COVERED DISTAL RELEASE STENT WAS TO BE IMPLANTED TO TREAT A 3-4CM MALIGNANT TRACHEAL STENOSIS DURING A METAL STENTING PROCEDURE PERFORMED ON (B)(6) 2023. THE PATIENT'S ANATOMY WAS TORTUOUS, AND THE ANATOMY WAS DILATED WITH BALLOON PRIOR STENT PLACEMENT. DURING THE PROCEDURE, THE STENT WAS FULLY DEPLOYED; HOWEVER, THE STENT COLLAPSED AND MOVED OUT OF ITS POSITION PROXIMALLY. THE STENT WAS REMOVED WITH FORCEPS, AND THE PROCEDURE WAS COMPLETED WITH ANOTHER MANUFACTURER DEVICE AS ANOTHER BSC DEVICE WAS NOT AVAILABLE FOR REDEPLOYMENT. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16444881 ↗
• InjuryMay 9, 2019Premature Activation; Material Twisted/Bent; Premature Activation; Material Twisted/Bent

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON APRIL 15, 2019 THAT AN ULTRAFLEX TRACHEOBRONCHIAL COVERED DISTAL RELEASE STENT WAS USED DURING AN AIRWAY STENT IMPLANTATION PROCEDURE PERFORMED ON (B)(6) 2019. ACCORDING TO THE COMPLAINANT, DURING STENT DEPLOYMENT, THE DELIVERY SYSTEM BENT AND THE STENT WAS DEPLOYED INTO THE WRONG LUNG. THE PHYSICIAN HAD TO EXTUBATE TO REMOVE THE STENT FROM THE PATIENT. REPORTEDLY, THE CASE WAS COMPLETED WITH NO PATIENT COMPLICATIONS. DESPITE NUMEROUS ATTEMPTS, BOSTON SCIENTIFIC HAS BEEN UNABLE TO OBTAIN ADDITIONAL INFORMATION REGARDING THE CIRCUMSTANCES SURROUNDING THIS EVENT. SHOULD ADDITIONAL RELEVANT DETAILS BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8595493 ↗