Ultraflex™ Tracheobronchial M00576320Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 08714729837701), received between Nov 23, 2016 and Feb 27, 2019 — 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.

• InjuryFeb 27, 2019Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2019 THAT AN ULTRAFLEX TRACHEOBRONCHIAL UNCOVERED DISTAL RELEASE STENT WAS IMPLANTED DURING A PROCEDURE PERFORMED ON (B)(6) 2018. ACCORDING TO THE COMPLAINANT, ON (B)(6) 2019, DURING A BRONCHOSCOPY PROCEDURE, IT WAS NOTED THAT THE STENT HAD SEVERAL BROKEN STRUTS ALONG THE MEMBRANOUS REGION ABOUT TWO-THIRDS (2/3) OF THE WAY DOWN. THE STENT WAS REMOVED FROM THE PATIENT, EXACT DATE UNKNOWN. NO ADVERSE EVENTS WERE REPORTED AS A RESULT OF THIS EVENT. NOTE: 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 Code Available

  MAUDE report 8375977 ↗
• MalfunctionNov 23, 2016Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  NOTE: THIS MANUFACTURER REPORT PERTAINS TO ONE OF TWO DEVICES USED IN THE SAME PROCEDURE. REFER TO MANUFACTURER REPORT # 3005099803-2016-03497 AND 3005099803-2016-03597 FOR THE OTHER ASSOCIATED DEVICE INFORMATION. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON NOVEMBER 1, 2016 THAT TWO ULTRAFLEX TRACHEOBRONCHIAL STENTS WERE TO BE USED IN THE RIGHT MAINSTEM BRONCHUS DURING A BRONCHOSCOPY WITH STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2016. ACCORDING TO THE COMPLAINANT, THE PHYSICIAN STARTED DEPLOYING THE FIRST ULTRAFLEX TRACHEOBRONCHIAL STENT (THE SUBJECT TO MFR REPORT # 3005099803-2016-03497) WHEN THE STENT COULD NOT BE FULLY DEPLOYED AND THE CATHETER BOWED. THE PARTIALLY DEPLOYED STENT WAS REMOVED FROM THE PATIENT. THE PHYSICIAN USED A SECOND ULTRAFLEX TRACHEOBRONCHIAL STENT (THE SUBJECT TO MFR REPORT # 3005099803-2016-03597); HOWEVER, THE STENT STILL COULD NOT BE FULLY DEPLOYED. DURING REMOVAL OF THE PARTIALLY DEPLOYED STENT, THE STENT SYSTEM GOT STUCK IN THE PATIENT¿S ENDOTRACHEAL TUBE. THE PHYSICIAN REMOVED THE ENDOTRACHEAL TUBE AND REINTUBATED THE PATIENT. REPORTEDLY, ANOTHER ULTRAFLEX TRACHEOBRONCHIAL STENT WAS IMPLANTED ONE WEEK POST-PROCEDURE. THERE WERE NO PATIENT

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6124625 ↗