Ultraflex™ Tracheobronchial M00576670Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 08714729842477), received between May 10, 2021 and Jul 6, 2021 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Difficult to Advance” (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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 6, 2021Difficult to Advance; Appropriate Device Problem Term/Code Not Available; Difficult to Advance; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON JUNE 14, 2021 THAT AN ULTRAFLEX TRACHEOBRONCHIAL COVERED DISTAL RELEASE STENT WAS TO BE IMPLANTED TO TREAT A STRICTURE DURING A BRONCHOSCOPY WITH STENT PLACEMENT PROCEDURE PERFORMED ON AN UNKNOWN DATE. DURING THE PROCEDURE, THE STENT WOULD NOT ADVANCE OVER THE GUIDEWIRE. THE PROCEDURE WAS CANCELLED BECAUSE ANOTHER STENT OF THE SAME SIZE WAS NOT AVAILABLE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12124052 ↗
• MalfunctionJul 6, 2021Difficult to Advance; Appropriate Device Problem Term/Code Not Available; Difficult to Advance; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2021 THAT AN ULTRAFLEX TRACHEOBRONCHIAL COVERED DISTAL RELEASE STENT WAS TO BE IMPLANTED TO TREAT A STRICTURE DURING A BRONCHOSCOPY WITH STENT PLACEMENT PROCEDURE PERFORMED ON AN UNKNOWN DATE. DURING THE PROCEDURE, THE STENT WOULD NOT ADVANCE OVER THE GUIDEWIRE. THE PROCEDURE WAS CANCELLED BECAUSE ANOTHER STENT OF THE SAME SIZE WAS NOT AVAILABLE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. NOTE: BOSTON SCIENTIFIC HAS BEEN UNABLE TO OBTAIN ADDITIONAL INFORMATION REGARDING THE EVENT TO DATE, DESPITE GOOD FAITH EFFORTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12123131 ↗
• InjuryMay 10, 2021Material Deformation; Positioning Problem; Material Deformation; Positioning Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON APRIL 20, 2021 THAT AN ULTRAFLEX TRACHEOBRONCHIAL COVERED DISTAL STENT WAS TO BE IMPLANTED TO TREAT A STRICTURE IN THE TRACHEA DURING A STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2021. DURING THE PROCEDURE, THE STENT WAS DEPLOYED TOO DISTAL IN THE TRACHEA. THE PHYSICIAN PULLED THE STENT RETRIEVAL SUTURE WITH A PAIR OF RESCUE FORCEPS AND MOVED THE STENT INTO ITS CORRECT POSITION. HOWEVER, AFTER THE STENT WAS REPOSITIONED, IT WAS NOTICED THAT THE STENT KINKED. THE PHYSICIAN WAS UNABLE TO FLATTEN THE STENT WITH THE SCOPE TIP AND FORCEPS. THE STENT WAS REMOVED FROM THE PATIENT WITH RESCUE FORCEPS AND A DIFFERENT STENT WAS IMPLANTED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. NOTE: BOSTON SCIENTIFIC HAS BEEN UNABLE TO OBTAIN ADDITIONAL INFORMATION REGARDING THE EVENT TO DATE, DESPITE GOOD FAITH EFFORTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11797883 ↗