Ultraflex™ Tracheobronchial M00576530Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 08714729842330), received between Oct 25, 2018 and Jan 4, 2024 — classified as 5 injuries, 1 malfunction.

The most frequently reported specific device problem is “Positioning 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryJan 4, 2024Activation Failure; Activation Failure

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ULTRAFLEX TRACHEOBRONCHIAL COVERED DISTAL STENT WAS TO BE IMPLANTED IN THE LEFT MAIN STEM OF THE LUNGS FOR THE PALLIATIVE TREATMENT OF LUNG CANCER DURING A PULMONARY TRACHEOBRONCHIAL STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2023. THE PATIENT'S ANATOMY WAS NOT TORTUOUS AND WAS NOT DILATED PRIOR TO STENT PLACEMENT. DURING THE PROCEDURE, THE STENT WAS SUCCESSFULLY DEPLOYED, BUT IT DID NOT EXPAND CORRECTLY. THE STENT WAS REMOVED FROM THE PATIENT WITH A PULMONARY RAT-TOOTH GRASPER, AND ANOTHER ULTRAFLEX TRACHEOBRONCHIAL STENT 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 18446587 ↗
• MalfunctionDec 20, 2023Activation, Positioning or Separation Problem; Material Twisted/Bent; Activation, Positioning or Separation Problem; Material Twisted/Bent

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ULTRAFLEX TRACHEOBRONCHIAL DISTAL RELEASE COVERED STENT WAS TO BE IMPLANTED TO TREAT A BRONCHIAL STRICTURE CAUSED BY LUNG CANCER DURING A BRONCHIAL STENTING PROCEDURE PERFORMED ON (B)(6) 2023. DURING THE PROCEDURE, THE STENT WAS ATTEMPTED TO BE DEPLOYED; HOWEVER, THE SHAFT STARTED TO BEND, AND THE STENT WAS UNABLE TO BE DEPLOYED. THE STENT WAS REMOVED FROM THE PATIENT PARTIALLY DEPLOYED AND ANOTHER ULTRAFLEX TRACHEOBRONCHIAL STENT WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18369347 ↗
• InjuryJan 31, 2022Break; Difficult to Remove; Unraveled Material; Positioning Problem; Break; Difficult to Remove; Unraveled Material; 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 MALIGNANT STRICTURE IN THE LEFT MAIN STEM OF THE LUNG DURING A TRACHEOBRONCHIAL STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2022. THE PATIENT'S ANATOMY WAS NOT TORTUOUS AND WAS NOT DILATED PRIOR TO STENT PLACEMENT. DURING THE PROCEDURE, THE STENT WAS MISDEPLOYED AND THE STENT LOCATION COULD NOT BE CONFIRMED UNDER LIVE FLUOROSCOPY DUE TO ANATOMICAL OR PROCEDURAL CIRCUMSTANCES. DURING REMOVAL OF THE DELIVERY SYSTEM, THE STENT WAS DISLODGED INTO THE TRACHEA. THE STENT WAS REMOVED FROM THE PATIENT WITH FORCEPS. DURING REMOVAL OF THE STENT, THE STENT WAS UNRAVELED AND THE STENT SUTURE WAS BROKEN. THE PROCEDURE WAS NOT COMPLETED DUE TO AVAILABILITY OF THE DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED DUE TO THIS EVENT. A PHOTO PROVIDED BY THE COMPLAINANT OF THE DEVICE OUTSIDE THE PATIENT SHOWED THE STENT WAS UNRAVELED AND THE STENT SUTURE WAS BROKEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13396780 ↗
• InjuryJan 22, 2020Difficult or Delayed Positioning; Material Twisted/Bent; Positioning Problem; Difficult or Delayed Positioning; Material Twisted/Bent; Positioning Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON DECEMBER 30, 2019 THAT AN ULTRAFLEX TRACHEOBRONCHIAL COVERED DISTAL RELEASE STENT WAS TO BE USED TO TREAT A MALIGNANT STRICTURE IN THE LEFT BRONCHUS DURING AN AIRWAY STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2019. REPORTEDLY, THE PATIENT'S ANATOMY WAS TORTUOUS AND WAS DILATED PRIOR TO STENT PLACEMENT. ACCORDING TO THE COMPLAINANT, THE STENT WAS POSITIONED IN THE LEFT BRONCHUS TOWARDS THE LEFT LOWER LOBE. DURING DEPLOYMENT, THE PULL STRING GOT "HUNG UP" AND THE STENT WAS DIFFICULT TO DEPLOY. THE DELIVERY SYSTEM WAS ADJUSTED TO MAKE THE STRING MORE FLUID TO RELEASE AND DEPLOYMENT WAS RESTARTED SEVERAL TIMES WITH THE DEPLOYMENT STRING GETTING HUNG UP SEVERAL TIMES. TOWARDS THE END OF DEPLOYMENT, THE DELIVERY CATHETER BOWED AND THE STENT SUDDENLY DEPLOYED IN AN INCORRECT LOCATION. THE STENT WAS REMOVED WITH FORCEPS AND ANOTHER ULTRAFLEX TRACHEOBRONCHIAL STENT WAS PLACED 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 GOOD.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9616375 ↗
• InjuryOct 25, 2018Positioning Problem; Activation Failure; Positioning Problem; Activation Failure

  NOTE: THIS REPORT PERTAINS TO ONE OF THE TWO DEVICES USED DURING THE SAME PROCEDURE. REFER TO MANUFACTURER REPORT # 3005099803-2018-60988 AND 3005099803-2018-60989 FOR THE ASSOCIATED DEVICE INFORMATION. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2018 THAT TWO ULTRAFLEX TRACHEOBRONCHIAL COVERED DISTAL RELEASE STENTS WERE TO BE USED TO TREAT A MALIGNANT STRICTURE DUE TO A TUMOR IN THE AIRWAY DURING A PULMONARY 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, THE STENT DEPLOYMENT SUTURE WAS RELEASED, BUT THE FIRST ULTRAFLEX TRACHEOBRONCHIAL STENT (THE SUBJECT OF MFR. REPORT # 3005099803-2018-60988) WOULD NOT EXPAND. IT WAS REPORTED THAT THE PLASTIC LUMEN ON THE STENT WOULD NOT OPEN AND REMAINED COMPRESSED AGAINST THE CATHETER. REPORTEDLY, THE STENT ENDED UP DEPLOYING "TOO HIGH UP" AND WAS NOT DEPLOYED IN THE PROPER LOCATION. THE PHYSICIAN REMOVED THE STENT WITH FORCEPS. A SECOND ULTRAFLEX TRACHEOBRONCHIAL STENT (THE SUBJECT OF THIS REPORT) WAS USED, BUT THE SAME ISSUE HAD OCCURRED. THE PROCEDURE WAS COMPLETED WITH ANOTHER ULTRAFLEX TRACHEOBRONC

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8005620 ↗
• InjuryOct 25, 2018Positioning Problem; Activation Failure; Positioning Problem; Activation Failure

  NOTE: THIS REPORT PERTAINS TO ONE OF THE TWO DEVICES USED DURING THE SAME PROCEDURE. REFER TO MANUFACTURER REPORT # 3005099803-2018-60988 AND 3005099803-2018-60989 FOR THE ASSOCIATED DEVICE INFORMATION. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2018 THAT TWO ULTRAFLEX TRACHEOBRONCHIAL COVERED DISTAL RELEASE STENTS WERE TO BE USED TO TREAT A MALIGNANT STRICTURE DUE TO A TUMOR IN THE AIRWAY DURING A PULMONARY 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, THE STENT DEPLOYMENT SUTURE WAS RELEASED, BUT THE FIRST ULTRAFLEX TRACHEOBRONCHIAL STENT (THE SUBJECT OF THIS REPORT) WOULD NOT EXPAND. IT WAS REPORTED THAT THE PLASTIC LUMEN ON THE STENT WOULD NOT OPEN AND REMAINED COMPRESSED AGAINST THE CATHETER. REPORTEDLY, THE STENT ENDED UP DEPLOYING "TOO HIGH UP" AND WAS NOT DEPLOYED IN THE PROPER LOCATION. THE PHYSICIAN REMOVED THE STENT WITH FORCEPS. A SECOND ULTRAFLEX TRACHEOBRONCHIAL STENT (THE SUBJECT OF MFR. REPORT # 3005099803-2018-60989) WAS USED, BUT THE SAME ISSUE HAD OCCURRED. THE PROCEDURE WAS COMPLETED WITH ANOTHER ULTRAFLEX TRACHEOBRONC

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8005614 ↗