Ultraflex™ Tracheobronchial M00576540Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 08714729842347), received between Mar 7, 2018 and Jul 27, 2026 — classified as 1 death, 1 injury.

The most frequently reported specific device problem is “Break” (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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• DeathJul 27, 2026Adverse Event Without Identified Device or Use Problem

  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 January 2023 to December 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) 2017. Patient Discharge Date: (b)(6) 2017. Adverse Event including Hemoptysis. Twenty-two days after discharge, the patient passed away.Note: IMDFR code F08 (Hospitalization or Prolonged Hospitalization), B1 (Adverse Event), and B2 (Hospitalization, Initial or Prolonged, dea

  Patient problems: Hemoptysis

  MAUDE report 50002918 ↗
• InjuryMar 7, 2018Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2018 THAT AN ULTRAFLEX TRACHEOBRONCHIAL COVERED DISTAL RELEASE STENT WAS TO BE USED TO TREAT A STRICTURE DUE TO SQUAMOUS CELL CARCINOMA OF THE LUNG IN THE LEFT MAINSTEM BRONCHUS DURING A BRONCHOSCOPY WITH STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2018. REPORTEDLY, THE PATIENT'S ANATOMY WAS NOT TORTUOUS AND WAS DILATED PRIOR TO STENT PLACEMENT. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE STENT WAS ABLE TO BE DEPLOYED. HOWEVER, IT APPEARED THAT ONE OF THE STENT LOOP WIRES WAS FRACTURED/BROKEN. THE STENT WAS REMOVED FROM THE PATIENT WITH 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 FINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7321806 ↗