Ultraflex™ Tracheobronchial M00576310Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 08714729837695), received between Dec 7, 2016 and Jul 19, 2018 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Activation, Positioning or Separation Problem” (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.

• InjuryJul 19, 2018Positioning Problem; Positioning Problem

  IT WAS NOTED BY BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2018 THAT AN ULTRAFLEX TRACHEOBRONCHIAL UNCOVERED DISTAL RELEASE STENT WAS TO BE USED TO TREAT A 7.1 X 8.8 CM MALIGNANT TUMOR IN THE RIGHT UPPER LOBE DURING A STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2018. REPORTEDLY, THE PATIENT¿S ANATOMY WAS DILATED PRIOR TO STENT PLACEMENT. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THERE WAS DIFFICULTY DEPLOYING THE STENT INSIDE THE PATIENT. THE PHYSICIAN PULLED THE STENT DEPLOYMENT SUTURE TO RELEASE THE STENT BUT NOTED THAT THE STENT WAS PULLED BACK ALONG WITH IT. EVENTUALLY, THE STENT DEPLOYMENT SUTURE FULLY RELEASED, AND THE STENT WAS DEPLOYED INSIDE THE PATIENT, BUT NOT IN THE TARGET LOCATION. THE STENT WAS REMOVED WITH FORCEPS AND ANOTHER ULTRAFLEX TRACHEOBRONCHIAL STENT WAS PLACED TO COMPLETE THE PROCEDURE. 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 7703783 ↗
• MalfunctionDec 7, 2016Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2016 THAT AN ULTRAFLEX TRACHEOBRONCHIAL DISTAL RELEASE UNCOVERED STENT WAS TO BE USED IN THE BRONCHUS DURING AN AIRWAY STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2016. REPORTEDLY, PATIENT¿S ANATOMY WAS NOT TORTUOUS. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE PHYSICIAN STARTED DEPLOYING THE STENT WHEN THE DEPLOYMENT SUTURE GOT STUCK AND THE CATHETER BOWED. THE PARTIALLY DEPLOYED STENT WAS REMOVED FROM THE PATIENT AND THE PROCEDURE WAS COMPLETED 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.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6152493 ↗