Ultraflex™ Tracheobronchial M00576570Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 08714729842378), received between Oct 9, 2017 and Dec 2, 2025 — classified as 3 injuries, 1 malfunction.

The most frequently reported specific device problem is “Positioning Problem” (2 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryDec 2, 2025Use of Device Problem; Material Deformation; Positioning Problem; Activation Failure; Use of Device Problem; Material Deformation; Positioning Problem; Activation Failure

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ULTRAFLEX TRACHEOBRONCHIAL COVERED DISTAL RELEASE STENT WAS TO BE IMPLANTED IN THE MAIN BRONCHIAL TO TREAT A NARROWING IN THE AIRWAY FOR MORE LUNG VOLUME DURING A TRACHEOBRONCHIAL STENT PLACEMENT PERFORMED ON (B)(6) 2025. THE PATIENT WAS NOT TORTUOUS AND WAS NOT DILATED PRIOR TO STENT PLACEMENT. DURING THE PROCEDURE, THE STENT WAS ABLE TO BE RELEASED FROM THE DELIVERY SYSTEM. HOWEVER, THE STENT DID NOT LOOK RIGHT AND WAS STILL SMASHED DOWN, AND THE STENT DID NOT EXPAND OFF THE DELIVERY SYSTEM. THE PHYSICIAN WAS ABLE TO PULL THE STENT AND PLACED ANOTHER TRACHEOBRONCHIAL STENT 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 23696074 ↗
• MalfunctionNov 25, 2020Activation, Positioning or Separation Problem; Material Twisted/Bent; Appropriate Device Problem Term/Code Not Available; Activation, Positioning or Separation Problem; Material Twisted/Bent; Appropriate Device Problem Term/Code Not Available

  NOTE: THIS REPORT PERTAINS TO ONE OF THE TWO DEVICES USED DURING THE SAME PROCEDURE. REFER TO MANUFACTURER REPORT # (B)(4) FOR THE ASSOCIATED DEVICE INFORMATION. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2020 THAT AN ULTRAFLEX TRACHEOBRONCHIAL COVERED DISTAL RELEASE STENT WAS TO BE IMPLANTED TO TREAT A MALIGNANT STRICTURE DURING A BRONCHOSCOPY WITH STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2020. REPORTEDLY, THE PATIENT'S ANATOMY WAS TIGHT AND WAS NOT DILATED PRIOR TO STENT PLACEMENT. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE ULTRAFLEX TRACHEOBRONCHIAL STENT (THE SUBJECT OF THIS REPORT) WAS ATTEMPTED TO BE DEPLOYED; HOWEVER, THE SHAFT BOWED AND THE STENT WAS PULLED PROXIMALLY AND NO LONGER CENTERED IN STRICTURE. THE STENT WAS REMOVED FROM THE PATIENT PARTIALLY DEPLOYED ON THE DELIVERY SYSTEM. REPORTEDLY, ANOTHER ULTRAFLEX TRACHEOBRONCHIAL STENT OF DIFFERENT SIZE (THE SUBJECT OF MFR. REPORT # (B)(4)) WAS USED, HOWEVER, THE SAME PROBLEM OCCURRED. THE SHAFT BOWED DURING ATTEMPTED DEPLOYMENT AND THE STENT WAS PARTIALLY DEPLOYED ON THE DELIVERY SYSTEM WHEN REMOVED FROM THE PATIENT. REPORTEDLY, THE PROCEDURE WAS NOT COMPLETED AS ANOTHER STENT OF THE SAME

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10906532 ↗
• InjuryFeb 24, 2020Break; Device-Device Incompatibility; Break; Device-Device Incompatibility

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A ULTRAFLEX TRACHEOBRONCHIAL STENT 14X30 WAS TO BE USED TO TREAT A MALIGNANCY IN THE LEFT MAIN STEM OF THE TRACHEA DURING A STENT IMPLANTATION PROCEDURE ON (B)(6) 2020. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE AND AFTER THE STENT WAS DEPLOYED, THE PHYSICIAN NOTICED THAT ONE OF THE STRUTS WAS BROKEN AND THE WIRE WAS POKING OUT. REPORTEDLY, FOR THE PATIENT'S SAFETY, THE PHYSICIAN DECIDED TO REMOVE THE STENT WITH RAT TOOTH FORCEPS. AS THE STENT WAS BEING REMOVED, THE STENT GOT STUCK IN THE LARYNGEAL MASK AIRWAY. THE STENT WAS REPLACED WITH ANOTHER ULTRAFLEX TRACHEOBRONCHIAL STENT 14X30 STENT FROM THE SHELF. 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 FINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9747227 ↗
• InjuryOct 9, 2017Positioning Problem; Positioning Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2017 THAT AN ULTRAFLEX TRACHEOBRONCHIAL COVERED DISTAL RELEASE STENT WAS TO BE USED TO TREAT A MALIGNANT STRICTURE IN THE LUNG DURING A BRONCHOSCOPY WITH STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2017. REPORTEDLY, THE PATIENT¿S ANATOMY WAS TORTUOUS. ACCORDING TO THE COMPLAINANT, DURING PREPARATION, THE NURSE NOTED THAT THE DELIVERY SYSTEM SEEMED BENT INSIDE THE PACKAGING. DURING THE PROCEDURE, THE PHYSICIAN STARTED DEPLOYING THE STENT BUT LOST THE TARGET AREA. THE PHYSICIAN CONTINUED DEPLOYING THE STENT, WHICH CAUSED THE STENT TO BE DEPLOYED MORE PROXIMALLY THAN DESIRED. THE MISDEPLOYED STENT WAS REMOVED FROM THE PATIENT AND 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 BE GOOD.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6930976 ↗