Ultraflex™ Tracheobronchial M00576650Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 08714729842453), received between Jun 4, 2020 and Aug 26, 2022 — classified as 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “Material Deformation” (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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryAug 26, 2022Break; Adverse Event Without Identified Device or Use Problem; Positioning Problem; Break; Adverse Event Without Identified Device or Use Problem; Positioning Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ULTRAFLEX TRACHEOBRONCHIAL COVERED DISTAL RELEASE STENT WAS TO BE IMPLANTED IN THE MID TRACHEA TO TREAT A MALIGNANT STENOSIS AND TRACHEOESOPHAGEAL (TE) FISTULA DURING A TRACHEAL STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2022. THE PATIENT'S ANATOMY WAS TORTUOUS. DURING THE PROCEDURE, THE ULTRAFLEX TRACHEOBRONCHIAL STENT WAS ABLE TO BE DEPLOYED BESIDE THE PREVIOUSLY IMPLANTED NON BOSTON SCIENTIFIC ESOPHAGEAL STENT. HOWEVER, THE ULTRAFLEX TRACHEOBRONCHIAL STENT WAS UNABLE TO SUPPORT THE LUMEN AND MOVED OUT OF ITS TARGET LOCATION. THE ULTRAFLEX TRACHEOBRONCHIAL STENT WAS REMOVED FROM THE PATIENT WITH A FLEXIBLE FORCEPS AND ANOTHER ULTRAFLEX TRACHEOBRONCHIAL STENT WAS IMPLANTED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION FOLLOWING THE PROCEDURE WAS REPORTED TO BE STABLE. NOTE: PHOTOS OF THE COMPLAINT DEVICE OUTSIDE THE PATIENT WERE PROVIDED BY THE COMPLAINANT AND SHOWED THE STENT WAS FULLY DEPLOYED AND THE GREEN RETENTION SUTURE WAS FOUND BROKEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15300390 ↗
• MalfunctionJul 6, 2020Material Deformation; Material Deformation

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2020 THAT AN ULTRAFLEX TRACHEOBRONCHIAL COVERED DISTAL RELEASE STENT WAS IMPLANTED TO TREAT A LARGE EXTRINSIC MALIGNANT TUMOR IN THE AIRWAY DURING A TRACHEAL STENTING 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 DEPLOYED SUCCESSFULLY. HOWEVER, WHEN THE PHYSICIAN INSPECTED THE STENT AFTER PLACEMENT VIA BRONCHOSCOPY, THE PHYSICIAN NOTICED THAT TWO OR THREE OF THE STENT LOOPS WERE BENT AND FLARING INWARDS. THE STENT REMAINS IMPLANTED AND THE PROCEDURE WAS REPORTED TO BE COMPLETED. REPORTEDLY, THE PHYSICIAN WAS COMFORTABLE LEAVING THE STENT IN PLACE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION FOLLOWING THE PROCEDURE WAS REPORTED TO BE FINE. REPORTEDLY, THE PATIENT WAS TRANSFERRED TO ANOTHER HOSPITAL FOR CHEMOTHERAPY AND RADIATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10235628 ↗
• InjuryJun 4, 2020Material Deformation; Positioning Problem; Material Deformation; Positioning Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) ,2020 THAT AN ULTRAFLEX TRACHEOBRONCHIAL COVERED DISTAL RELEASE STENT WAS TO BE USED TO TREAT A TRACHEOBRONCHIAL MALACIA DURING A TRACHEOBRONCHIAL AIRWAY STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6), 2020. REPORTEDLY, THE STENT WAS PLACED TO MAINTAIN LUMINAL PATENCY. THE PATIENT'S ANATOMY WAS NOT TORTUOUS AND WAS NOT DILATED PRIOR TO STENT PLACEMENT ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE STENT WAS FULLY DEPLOYED. THE PHYSICIAN ADJUSTED THE STENT INTO THE CORRECT POSITION USING RAT TOOTHED FORCEPS BY PULLING THE DISTAL BLUE RETRIEVAL SUTURE TO MOVE THE STENT DISTALLY TOWARDS THE MAIN CARINA. REPORTEDLY, THROUGH DIRECT VISUALIZATION VIA THE BRONCHOSCOPE IMAGE THE PHYSICIAN NOTICED THREE OF THE STENT LOOP WIRES WERE BENT AT 90 DEGREES INTO THE LUMEN. THE PHYSICIAN TRIED TO FLATTEN THE BENT LOOP ENDS WITH THE SCOPE BY PUSHING THEM DOWN TO THE AIRWAY WALL, BUT HE WAS UNSUCCESSFUL. THE STENT WAS REMOVED FROM THE PATIENT WITH RAT TOOTH GRASPING FORCEPS FROM THE PROXIMAL END. AFTER REMOVAL OF THE STENT FROM THE PATIENT, IT WAS NOTED THAT THE THREE LOOPED ENDS WERE SEVERELY BENT INWARD. REPORTEDLY, NO NEW STENT WAS

  Patient problems: Injury; No Consequences Or Impact To Patient

  MAUDE report 10121009 ↗