Ultraflex™ Tracheobronchial M00576690Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 08714729842491), received between Jun 19, 2018 and Jul 25, 2023 — classified as 2 injuries.

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

• InjuryJul 25, 2023Positioning Problem; Positioning Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON JULY 07, 2023 THAT AN ULTRAFLEX TRACHEOBRONCHIAL COVERED DISTAL STENT WAS TO BE IMPLANTED IN THE LEFT BRONCHUS TO TREAT A 1CM MALIGNANT OBSTRUCTION DURING A STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2023. THE PATIENT'S ANATOMY WAS TORTUOUS AND WAS NOT DILATED PRIOR TO STENT PLACEMENT. DURING THE PROCEDURE, THE STENT WAS DEPLOYED BEYOND THE INDICATED RO (RADIOPAQUE) MARKERS AND WAS NOT PLACED IN THE TARGET LOCATION. THE STENT WAS REMOVED AND A DIFFERENT DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17393914 ↗
• InjuryJun 19, 2018Material Deformation; Positioning Problem; Material Deformation; Positioning Problem

  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 IN THE AIRWAY DUE TO TRACHEOBRONCHOMALACIA DURING A STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2018. REPORTEDLY, THE PATIENT¿S ANATOMY WAS NOT TORTUOUS AND WAS NOT DILATED PRIOR TO STENT PLACEMENT. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE STENT WAS ABLE TO BE DEPLOYED. HOWEVER, THE STENT WAS PLACED IN AN INCORRECT LOCATION, AND THE STENT APPEARED FOLDED UNDER FLUOROSCOPIC VIEW. THE STENT WAS REMOVED WITH FORCEPS. THE PHYSICIAN RESCHEDULED THE PROCEDURE ON THE FOLLOWING DAY, AND COMPLETED IT 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. THE COMPLAINANT REPORTED THAT THEY COMPARED THE DELIVERY SYSTEM OF THE COMPLAINT DEVICE WITH THE DELIVERY SYSTEM OF THE DEVICE SUCCESSFULLY USED TO COMPLETE THE PROCEDURE AND NOTED THAT THE DISTANCE FROM THE DISTAL RO MARKER TO THE DILATION TIP OF THE DEVICE WAS LONGER ON THE COMPLAINANT DELIVERY SYSTEM.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7616131 ↗