Ultraflex™ Tracheobronchial M00576560Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 08714729842361), received between Aug 7, 2017 and Apr 1, 2024 — classified as 4 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Activation, Positioning or Separation Problem” (4 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• InjuryApr 1, 2024Material Twisted/Bent; Positioning Problem; Material Twisted/Bent; Positioning Problem

  NOTE: THIS REPORT PERTAINS TO ONE OF THE TWO DEVICES USED ON THE SAME PATIENT. REFER TO MANUFACTURER REPORT NUMBER 3005099803-2024-01392 FOR THE ASSOCIATED DEVICE INFORMATION. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT TWO ULTRAFLEX TRACHEOBRONCHIAL COVERED DISTAL STENTS WERE TO BE IMPLANTED IN THE LOWER LEFT LOBE OF THE LUNGS TO TREAT BRONCHIAL STRICTURES SECONDARY TO LUNG CANCER DURING A BRONCHIAL STENTING PROCEDURE PERFORMED ON (B)(6) 2024. DURING THE PROCEDURE, WHILE ATTEMPTING TO PLACE THE FIRST ULTRAFLEX TRACHEOBRONCHIAL STENT (THE SUBJECT OF THIS REPORT), THE STENT DEPLOYMENT SUTURE GOT STUCK CAUSING THE SHAFT TO BEND. THE STENT WAS ABLE TO FULLY DEPLOY; HOWEVER, IT MOVED AWAY FROM THE INTENDED POSITION. A SECOND ULTRAFLEX TRACHEOBRONCHIAL STENT (THE SUBJECT OF MFR. REPORT NUMBER) WAS OPENED AND THE SAME PROBLEM OCCURRED. THE STENTS WERE REMOVED FROM THE PATIENT WITH FORCEPS, AND THE PROCEDURE WAS EVENTUALLY CANCELED AND RESCHEDULED FOR LATER THE SAME DAY. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19014501 ↗
• InjuryApr 1, 2024Material Twisted/Bent; Positioning Problem; Material Twisted/Bent; Positioning Problem

  NOTE: THIS REPORT PERTAINS TO ONE OF THE TWO DEVICES USED ON THE SAME PATIENT. REFER TO MANUFACTURER REPORT NUMBER 3005099803-2024-01391 AND 3005099803-2024-01392 FOR THE ASSOCIATED DEVICE INFORMATION. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT TWO ULTRAFLEX TRACHEOBRONCHIAL COVERED DISTAL STENTS WERE TO BE IMPLANTED IN THE LOWER LEFT LOBE OF THE LUNGS TO TREAT BRONCHIAL STRICTURES SECONDARY TO LUNG CANCER DURING A BRONCHIAL STENTING PROCEDURE PERFORMED ON (B)(6) 2024. DURING THE PROCEDURE, WHILE ATTEMPTING TO PLACE THE FIRST ULTRAFLEX TRACHEOBRONCHIAL STENT (THE SUBJECT OF MFR. REPORT NUMBER 3005099803-2024-01391), THE STENT DEPLOYMENT SUTURE GOT STUCK CAUSING THE SHAFT TO BEND. THE STENT WAS ABLE TO FULLY DEPLOY; HOWEVER, IT MOVED AWAY FROM THE INTENDED POSITION. A SECOND ULTRAFLEX TRACHEOBRONCHIAL STENT (THE SUBJECT OF THIS REPORT) WAS OPENED AND THE SAME PROBLEM OCCURRED. THE STENTS WERE REMOVED FROM THE PATIENT WITH FORCEPS, AND THE PROCEDURE WAS EVENTUALLY CANCELED AND RESCHEDULED FOR LATER THE SAME DAY. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19014497 ↗
• MalfunctionFeb 2, 2024Use of Device Problem; Activation, Positioning or Separation Problem; Use of Device Problem; Activation, Positioning or Separation Problem

  NOTE: THIS REPORT PERTAINS TO ONE OF TWO DEVICES USED DURING THE SAME PROCEDURE. REFER TO MANUFACTURER REPORT # 3005099803-2024-00164 AND 3005099803-2024-00163 FOR THE ASSOCIATED DEVICE INFORMATION. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ULTRAFLEX TRACHEOBRONCHIAL DISTAL RELEASE COVERED STENT WAS TO BE IMPLANTED IN THE INTERMEDIUS BRONCHUS DURING A STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2024. THE PATIENT'S ANATOMY WAS NOT TORTUOUS. DURING THE PROCEDURE, THE STENT (THE SUBJECT OF THIS REPORT) WAS UNABLE TO BE DEPLOYED. THE DEVICE WAS REMOVED. THE PHYSICIAN THEN ATTEMPTED TO DEPLOY THE STENT OUTSIDE AND WAS ABLE TO UNRAVEL THE FIRST TWO SUTURES. THE STENT WAS RELOADED, AND ANOTHER ATTEMPT WAS MADE TO DEPLOY THE STENT; HOWEVER, THE STENT STILL DID NOT DEPLOY. THE DEVICE WAS REMOVED, AND ANOTHER ULTRAFLEX TRACHEOBRONCHIAL STENT (THE SUBJECT OF MFR. REPORT # 3005099803-2024-00163) WAS ATTEMPTED TO BE DEPLOYED; HOWEVER, THE SAME ISSUE OCCURRED. THE PROCEDURE WAS COMPLETED USING A NON-BOSTON SCIENTIFIC DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. NOTE: IT WAS REPORTED THAT "THE STENT WAS REMOVED, AND THE FIRST TWO SUTURES WERE UNRAVELED O

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18636294 ↗
• MalfunctionFeb 2, 2024Use of Device Problem; Activation, Positioning or Separation Problem; Use of Device Problem; Activation, Positioning or Separation Problem

  NOTE: THIS REPORT PERTAINS TO ONE OF TWO DEVICES USED DURING THE SAME PROCEDURE. REFER TO MANUFACTURER REPORT # 3005099803-2024-00164 AND 3005099803-2024-00163 FOR THE ASSOCIATED DEVICE INFORMATION. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ULTRAFLEX TRACHEOBRONCHIAL DISTAL RELEASE COVERED STENT WAS TO BE IMPLANTED IN THE INTERMEDIUS BRONCHUS DURING A STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2024. THE PATIENT'S ANATOMY WAS NOT TORTUOUS. DURING THE PROCEDURE, THE STENT (THE SUBJECT OF MFR. REPORT # 3005099803-2024-00164) WAS UNABLE TO BE DEPLOYED. THE DEVICE WAS REMOVED. THE PHYSICIAN THEN ATTEMPTED TO DEPLOY THE STENT OUTSIDE AND WAS ABLE TO UNRAVEL THE FIRST TWO SUTURES. THE STENT WAS RELOADED, AND ANOTHER ATTEMPT WAS MADE TO DEPLOY THE STENT; HOWEVER, THE STENT STILL DID NOT DEPLOY. THE DEVICE WAS REMOVED, AND ANOTHER ULTRAFLEX TRACHEOBRONCHIAL STENT (THE SUBJECT OF THIS REPORT) WAS ATTEMPTED TO BE DEPLOYED; HOWEVER, THE SAME ISSUE OCCURRED. THE PROCEDURE WAS COMPLETED USING A NON-BOSTON SCIENTIFIC DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. NOTE: IT WAS REPORTED THAT "THE STENT WAS REMOVED, AND THE FIRST TWO SUTURES WERE UNRAVELED O

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18631266 ↗
• MalfunctionFeb 2, 2024Use of Device Problem; Activation, Positioning or Separation Problem; Use of Device Problem; Activation, Positioning or Separation Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ULTRAFLEX TRACHEOBRONCHIAL STENT WAS TO BE IMPLANTED IN THE BRONCHUS INTERMEDIUS DURING A STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2024. THE PATIENT'S ANATOMY WAS NOT TORTUOUS PRIOR TO STENT PLACEMENT. DURING THE PROCEDURE, THE PHYSICIAN ATTEMPTED TO DEPLOY THE STENT BY PULLING THE SUTURE WITH EXCESSIVE FORCE, BUT THE STENT COULD NOT BE DEPLOYED. THE STENT WAS THEN REMOVED FROM THE PATIENT, AND THE FIRST TWO SUTURES WERE MANUALLY UNRAVELED. THE PARTIALLY DEPLOYED STENT WAS PUT BACK INTO THE PATIENT TO ATTEMPT FULL DEPLOYMENT, BUT IT COULD STILL NOT BE DEPLOYED USING EXCESSIVE FORCE. A NON-BOSTON SCIENTIFIC STENT WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. NOTE: IT WAS REPORTED THAT THE FIRST TWO SUTURES WERE MANUALLY UNRAVELED AND THE STENT WAS PUT BACK INSIDE THE PATIENT TO ATTEMPT FULL DEPLOYMENT. PER THE INSTRUCTIONS FOR USE (IFU), "WARNING: DO NOT ATTEMPT TO RELOAD A DEPLOYED OR PARTIALLY DEPLOYED STENT." THE USER DID NOT FOLLOW THE STEPS OF THE IFU.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18631075 ↗
• MalfunctionJul 3, 2023Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON JUNE 13, 2023, THAT AN ULTRAFLEX TRACHEOBRONCHIAL COVERED DISTAL RELEASE STENT WAS TO BE IMPLANTED IN THE LEFT MAIN BRONCHUS TO TREAT A 2 CM MALIGNANT STRICTURE DUE TO CANCER IN THE ESOPHAGUS DURING A BRONCHIAL METAL STENTING PROCEDURE PERFORMED ON (B)(6) 2023. THE PATIENT'S ANATOMY WAS NOT TORTUOUS AND WAS DILATED PRIOR TO STENT PLACEMENT. DURING THE PROCEDURE, THE ULTRAFLEX TRACHEOBRONCHIAL STENT COULD ONLY BE PARTIALLY RELEASED AFTER PULLING THE DEPLOYMENT SUTURE. THE STENT WAS REMOVED FROM THE PATIENT PARTIALLY DEPLOYED ON THE DELIVERY SYSTEM, AND A DIFFERENT STENT WAS IMPLANTED 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 17248846 ↗
• InjuryDec 5, 2022Material Deformation; Positioning Problem; Material Deformation; Positioning Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6), 2022, THAT AN ULTRAFLEX TRACHEOBRONCHIAL COVERED DISTAL RELEASE STENT WAS TO BE IMPLANTED TO TREAT A 2/2.5CM MALIGNANT TRACHEAL STENOSIS DURING A METAL STENTING PROCEDURE PERFORMED ON (B)(6), 2022. THE PATIENT'S ANATOMY WAS TORTUOUS AND WAS DILATED PRIOR TO STENT PLACEMENT. DURING THE PROCEDURE, THE STENT WAS FULLY DEPLOYED; HOWEVER, THE STENT DEFORMED DUE TO THE PRESSURE OF THE STRICTURE AND MOVED OUT OF ITS POSITION DISTALLY. THE STENT WAS REMOVED USING FORCEPS AND ANOTHER ULTRAFLEX TRACHEOBRONCHIAL STENT WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15916554 ↗
• MalfunctionJun 17, 2022Difficult or Delayed Positioning; Positioning Problem; Difficult or Delayed Positioning; Positioning Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON MAY 27, 2022 THAT AN ULTRAFLEX TRACHEOBRONCHIAL COVERED DISTAL RELEASE STENT WAS TO BE IMPLANTED TO TREAT A MALIGNANT INTRINSIC TUMOR IN THE LEFT MAIN STEM BRONCHUS DURING A STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2022. THE PATIENT'S ANATOMY WAS TORTUOUS AND WAS DILATED PRIOR TO STENT PLACEMENT. DURING THE PROCEDURE, THE PHYSICIAN APPLIED A LOT OF FORCE TO DEPLOY THE ULTRAFLEX STENT. THE STENT WAS FULLY DEPLOYED BUT, A PORTION OF THE STENT WAS LODGED IN THE ENDOTRACHEAL (ET) TUBE. THE ET TUBE ALONG WITH THE STENT WERE REMOVED COMPLETELY. THE PATIENT WAS RE-INTUBATED AND THE PROCEDURE WAS COMPLETED WITH ANOTHER ULTRAFLEX TRACHEOBRONCHIAL STENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14737353 ↗
• InjuryAug 7, 2017Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2017 THAT AN ULTRAFLEX TRACHEOBRONCHIAL DISTAL RELEASE STENT WAS USED TO TREAT A 4 TO 5 CM MALIGNANT STRICTURE IN THE TRACHEA DURING A BRONCHOSCOPY WITH STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2017. REPORTED, THE PATIENT'S ANATOMY WAS NARROWED AND HAD BEEN DILATED TWICE PRIOR TO STENT PLACEMENT: FROM 8 MM TO 10 MM WITH A PULMONARY DILATATION BALLOON THEN 10 MM TO 12 MM WITH A SECOND PULMONARY DILATATION BALLOON. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE PHYSICIAN WAS ABLE TO DEPLOY THE STENT AT THE CORRECT ANATOMY LOCATION. HOWEVER, DURING THE REMOVAL OF THE SCOPE, THE PHYSICIAN NOTED THAT THERE WAS A SHARP PIECE STICKING OUT OF THE PROXIMAL END OF THE STENT. THE FULLY DEPLOYED STENT WAS REMOVED USING RAT TOOTH FORCEPS AND WAS EXAMINED BY THE PHYSICIAN UNDER A MICROSCOPE. THE MICROSCOPIC EXAMINATION PERFORMED BY THE PHYSICIAN CONFIRMED THE DAMAGE NOTED ON THE PROXIMAL END OF THE STENT UPON SCOPE WITHDRAWAL. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. 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

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6771680 ↗