Ultraflex™ Tracheobronchial M00576610Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 08714729842415), received between Jun 18, 2020 and Nov 25, 2020 — classified as 1 injury, 1 malfunction.

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

• 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 # 3005099803-2020-05601 FOR THE ASSOCIATED DEVICE INFORMATION. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON NOVEMBER 2, 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 MFR. REPORT # 3005099803-2020-05601) WAS ATTEMPTED TO BE DEPLOYED; HOWEVER, THE SHAFT BOWED AND THE STENT WAS PULLED PROXIMALLY AND NO LONGER CENTERED IN THE 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 THIS REPORT) 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

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10906476 ↗
• InjuryJun 18, 2020Activation Failure; Activation Failure

  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 NEOPLASM IN THE DISTAL TRACHEA DURING A TRACHEOBRONCHIAL AIRWAY STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2020. REPORTEDLY, THE PATIENT'S ANATOMY WAS SLIGHTLY TORTUOUS AND WAS NOT DILATED PRIOR TO STENT PLACEMENT. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE STENT WAS DEPLOYED AND THE DELIVERY SYSTEM WAS SUCCESSFULLY REMOVED FROM THE PATIENT. REPORTEDLY, THE PHYSICIAN INTRODUCED THE BRONCHOSCOPE TO CHECK FOR STENT PLACEMENT AND IT WAS NOTED THAT THE DISTAL PORTION OF THE STENT DID NOT FULLY EXPAND; THE NITINOL LOOPS BENT INWARDS. THE PHYSICIAN ATTEMPTED TO ADJUST THE STENT BY PULLING THE STENT BOTH PROXIMALLY AND DISTALLY WITH RAT-TOOTHED GRASPING FORCEPS, BUT THE STENT DID NOT FULLY EXPAND AT THE DISTAL END. THE STENT WAS REMOVED WITH RAT- TOOTHED FORCEPS AND A DIFFERENT STENT WAS PLACED TO COMPLETE THE PROCEDURE. 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 STABLE AND FINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10171187 ↗