Ultraflex™ Tracheobronchial M00576410Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 08714729837770), received between Jan 31, 2017 and Aug 6, 2021 — classified as 2 injuries, 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryAug 6, 2021Difficult to Remove; Positioning Problem; Difficult to Remove; Positioning Problem

  NOTE: THIS REPORT PERTAINS TO ONE OF THE TWO DEVICES USED DURING THE SAME PROCEDURE. REFER TO MANUFACTURING REPORT# 3005099803-2021-04016 FOR THE ASSOCIATED DEVICE INFORMATION. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2021 THAT AN ULTRAFLEX TRACHEOBRONCHIAL UNCOVERED PROXIMAL RELEASE STENT WAS TO BE IMPLANTED IN THE RIGHT MIDDLE LOBE (RML) TO TREAT A LUNG STRICTURE AND TO OPEN A COLLAPSED AIRWAY DURING AN AIRWAY STENT CASE PROCEDURE PERFORMED ON (B)(6) 2021. REPORTEDLY, THE PATIENT'S ANATOMY APPEARED TIGHT AND WAS NOT DILATED PRIOR TO STENT PLACEMENT. DURING THE PROCEDURE, THE STENT WAS DEPLOYED SUCCESSFULLY; HOWEVER, UNDER DIRECT ENDOSCOPIC VISUALIZATION, IT WAS OBSERVED THAT THE ULTRAFLEX TRACHEOBRONCHIAL STENT (THE SUBJECT OF THIS REPORT) WAS DISLODGED OUT OF ITS CORRECT LOCATION WHEN THE DELIVERY SYSTEM WAS ATTEMPTED TO BE REMOVED. THE PHYSICIAN ATTEMPTED TO READJUST THE STENT INTO THE CORRECT POSITION USING FORCEPS AND A BALLOON; HOWEVER, THE ATTEMPT WAS UNSUCCESSFUL. THE STENT WAS REMOVED FROM THE PATIENT WITH FORCEPS AND A 10X30 ULTRAFLEX TRACHEOBRONCHIAL STENT (THE SUBJECT OF MFR. REPORT# 3005099803-2021-04016) WAS IMPLANTED; HOWEVER, THE SAME PROBLEM OCCU

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12288355 ↗
• MalfunctionNov 12, 2020Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2020 THAT AN ULTRAFLEX TRACHEOBRONCHIAL UNCOVERED PROXIMAL RELEASE STENT WAS TO BE USED TO TREAT A MALIGNANT STRICTURE DURING A BRONCHOSCOPY WITH STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2020. REPORTEDLY, THE PATIENT'S ANATOMY WAS TORTUOUS AND WAS DILATED PRIOR TO STENT PLACEMENT. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE STENT WAS ATTEMPTED TO BE DEPLOYED BUT THE BLACK DEPLOYMENT SUTURE DID NOT UNRAVEL. REPORTEDLY, THE STENT WAS REMOVED FROM THE PATIENT PARTIALLY DEPLOYED ON THE DELIVERY SYSTEM. IT IS UNKNOWN IF THE PROCEDURE WAS COMPLETED; HOWEVER, IT WAS REPORTED THAT THERE WAS NO OTHER STENT USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10829011 ↗
• InjuryJan 31, 2017Premature Activation; Premature Activation

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON JANUARY 11, 2017 THAT AN ULTRAFLEX¿ TRACHEOBRONCHIAL STENT WAS TO BE IMPLANTED IN THE RIGHT MIDDLE LOBE STEM DURING A STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2017. REPORTEDLY, THERE WERE TWO NON-BSC STENTS THAT WERE IMPLANTED IN THE SITE. ACCORDING TO THE COMPLAINANT, WHEN THE PHYSICIAN STARTED DEPLOYING THE STENT, THE CATHETER BOWED AND THE STENT WAS DEPLOYED INADVERTENTLY DISTAL FROM THE STRICTURE. THE STENT KNOCKED OUT THE TWO NON-BSC STENTS. THE PHYSICIAN REMOVED THE THREE STENTS 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 6290656 ↗