Ultraflex™ Esophageal NG M00514200Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 08714729121190), received between Jul 27, 2017 and Nov 14, 2025 — classified as 9 injuries, 2 malfunctions.

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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• InjuryNov 14, 2025Premature Activation; Premature Activation

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ULTRAFLEX ESOPHAGEAL STENT WAS TO BE IMPLANTED DURING A PROCEDURE PERFORMED ON (B)(6) 2025. DURING PROCEDURE, THE STENT WAS DIFFICULT TO RELEASE EVEN AFTER PULLING THE THREAD TO BEGIN RELEASE. WHEN THE STENT WAS RETRACTED DURING DELIVERY REMOVAL, IT WAS PARTIALLY RETRACTED. EVENTUALLY, THE STENT SUDDENLY RELEASED MAKING IT DIFFICULT TO PLACE IT IN THE INTENDED LOCATION. THE PROCEDURE WAS COMPLETED USING A PROXIMAL RELEASE VERSION OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23556549 ↗
• MalfunctionNov 20, 2023Failure to Advance; Activation, Positioning or Separation Problem; Failure to Advance; Activation, Positioning or Separation Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ULTRAFLEX ESOPHAGEAL COVERED DISTAL STENT WAS USED TO TREAT A 3CM MALIGNANT ESOPHAGEAL STENOSIS DURING A STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2023. THE PATIENT'S ANATOMY WAS TORTUOUS AND WAS NOT DILATED PRIOR TO STENT PLACEMENT. DURING THE PROCEDURE, THE DEVICE WAS UNABLE TO CROSS THE LESION DUE TO SEVERE STENOSIS AND THE STENT COULD NOT BE RELEASED WHEN DEPLOYMENT WAS ATTEMPTED. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. 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 18173089 ↗
• MalfunctionMar 3, 2023Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON FEBRUARY 14, 2023, THAT AN ULTRAFLEX ESOPHAGEAL NG DISTAL COVERED STENT WAS TO BE IMPLANTED IN THE MIDDLE ESOPHAGUS TO TREAT A 6CM ESOPHAGEAL STRICTURE DURING A STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2023. THE PATIENT'S ANATOMY WAS NOT TORTUOUS, AND IT WAS NOT DILATED PRIOR TO STENT PLACEMENT. DURING THE PROCEDURE, THE ULTRAFLEX ESOPHAGEAL STENT DEPLOYMENT SUTURE WAS RELEASED APPROXIMATELY 50% AND THE STENT COULD NOT BE DEPLOYED ANY FURTHER. THE ULTRAFLEX ESOPHAGEAL STENT WAS REMOVED FROM THE PATIENT PARTIALLY DEPLOYED TOGETHER WITH THE DELIVERY SYSTEM AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT STATUS WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16481008 ↗
• InjuryAug 10, 2022Positioning Problem; Activation Failure; Positioning Problem; Activation Failure

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON JULY 25, 2022 THAT AN ULTRAFLEX ESOPHAGEAL NG DISTAL RELEASE COVERED STENT WAS IMPLANTED DURING A PROCEDURE PERFORMED ON (B)(6) 2022. DURING THE PROCEDURE, POOR STENT POSITIONING WAS NOTED ON THE ULTRAFLEX ESOPHAGEAL STENT.. THERE WERE NO PATIENT COMPLICATIONS REPORTED DUE TO THIS EVENT. NOTE: NO FURTHER INFORMATION HAS BEEN OBTAINED DESPITE GOOD FAITH EFFORTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15201426 ↗
• InjuryMay 12, 2021Activation Failure; Activation Failure

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2021 THAT AN ULTRAFLEX ESOPHAGEAL NG DISTAL RELEASE COVERED STENT WAS TO BE IMPLANTED TO TREAT AN ESOPHAGEAL TUMOR DURING AN ESOPHAGEAL STENTING PROCEDURE PERFORMED ON (B)(6) 2021. REPORTEDLY, THE PATIENT'S ANATOMY WAS TORTUOUS AND WAS NOT DILATED PRIOR TO STENT PLACEMENT. DURING THE PROCEDURE, THE STENT WAS FULLY DEPLOYED INSIDE THE PATIENT; HOWEVER, UNDER ENDOSCOPIC VIEW, IT WAS NOTED THAT THE STENT DID NOT EXPAND. THE STENT WAS REMOVED FROM THE PATIENT USING A RAT TOOTH FORCEPS AND ANOTHER ULTRAFLEX ESOPHAGEAL STENT WAS IMPLANTED 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.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11812187 ↗
• InjuryDec 8, 2020Migration; Migration

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2020 THAT AN ULTRAFLEX ESOPHAGEAL NG DISTAL COVERED STENT WAS IMPLANTED TO TREAT A STENOSIS IN THE ESOPHAGUS DURING A STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2020. ACCORDING TO THE COMPLAINANT, THE STENT WAS DEPLOYED SUCCESSFULLY. X-RAY IMAGING WAS PERFORMED 24 HOURS POST STENT PLACEMENT AND IT WAS CONFIRMED THAT THE STENT WAS PLACED IN THE TARGET LOCATION; HOWEVER, ON (B)(6) 2020, IMAGING WAS PERFORMED AND IT WAS NOTED THAT THE STENT HAD MIGRATED ALMOST INTO THE PATIENT'S STOMACH. REPORTEDLY, THE STENT WAS REMOVED AND THE PROCEDURE WAS COMPLETED WITH ANOTHER ULTRAFLEX ESOPHAGEAL STENT. 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 Code Available

  MAUDE report 10967510 ↗
• InjuryNov 23, 2020Positioning Problem; Positioning Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2020 THAT AN ULTRAFLEX ESOPHAGEAL NG DISTAL RELEASE COVERED STENT WAS TO BE IMPLANTED TO TREAT A 6CM DISTAL ESOPHAGEAL STRICTURE DURING AN ESOPHAGOGASTRODUODENOSCOPY (EGD) WITH STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2020. REPORTEDLY, THE PATIENT'S ANATOMY WAS NOT TORTUOUS AND WAS NOT DILATED PRIOR TO STENT PLACEMENT. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, FLUOROSCOPIC IMAGE DID NOT PROVIDE ADEQUATE PICTURE OF THE STENT DUE TO ANATOMICAL FACTORS; HOWEVER, THE STENT WAS DEPLOYED INSIDE THE PATIENT BUT WAS PROXIMAL TO THE STRICTURE. THE STENT WAS REMOVED FROM THE PATIENT WITH GRASPING FORCEPS AND PROCEDURE WAS COMPLETED WITH A 12CM WALLFLEX STENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10885175 ↗
• InjuryOct 19, 2020Positioning Problem; Positioning Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON SEPTEMBER 27, 2020 THAT AN ULTRAFLEX ESOPHAGEAL NG DISTAL RELEASE COVERED STENT WAS TO BE IMPLANTED IN THE ESOPHAGUS TO TREAT ESOPHAGEAL CANCER DURING A STENT IMPLANTATION PROCEDURE PERFORMED ON (B)(6) 2020. ACCORDING TO THE COMPLAINANT, AFTER THE STENT WAS DEPLOYED, THE STENT MOVED OUT OF ITS CORRECT POSITION. THE STENT WAS REMOVED FROM THE PATIENT WITH FORCEPS AND ANOTHER ULTRAFLEX ESOPHAGEAL STENT WAS IMPLANTED 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.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10701638 ↗
• InjuryOct 19, 2020Positioning Problem; Positioning Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON SEPTEMBER 27, 2020 THAT AN ULTRAFLEX ESOPHAGEAL NG DISTAL RELEASE COVERED STENT WAS TO BE IMPLANTED TO TREAT A MALIGNANT ESOPHAGEAL STENOSIS DURING A STENT IMPLANTATION PROCEDURE PERFORMED ON (B)(6) 2020. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE STENT WAS COMPLETELY DEPLOYED; HOWEVER, THE STENT MOVED OUT OF ITS POSITION. THE STENT WAS REMOVED USING A FORCEPS AND THE PROCEDURE WAS COMPLETED WITH ANOTHER ULTRAFLEX ESOPHAGEAL STENT. 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.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10701558 ↗
• InjuryMay 13, 2020Material Deformation; Activation Failure; Material Deformation; Activation Failure

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ULTRAFLEX ESOPHAGEAL NG STENT WAS TO BE IMPLANTED TO TREAT A MALIGNANT ESOPHAGUS STENOSIS DURING AN ESOPHAGOGASTRODUODENOSCOPY (EGD) PROCEDURE PERFORMED ON (B)(6) 2020. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, AFTER THE STENT WAS PLACED IN THE CORRECT POSITION AND THE SUTURE WAS REMOVED THE PHYSICIAN SAW THAT THE STENT WAS NOT FULLY EXPANDED AND THE STENT WAS TORQUED. THE ULTRAFLEX ESOPHAGEAL NG STENT WAS REMOVED FROM THE PATIENT AND THE PROCEDURE WAS COMPLETED WITH A NON-BOSTON SCIENTIFIC COOK STENT. 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, GOOD, AND FINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10053611 ↗
• InjuryJul 27, 2017Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON JULY 7, 2017 THAT AN ULTRAFLEX ESOPHAGEAL DISTAL RELEASE COVERED STENT WAS IMPLANTED (B)(6) 2017. ACCORDING TO THE COMPLAINANT, 2 DAYS POST STENT PLACEMENT, A BARIUM STUDY WAS PERFORMED AND IT WAS NOTED THAT THE LEAK WAS STILL PRESENT. THE IMPLANT SITE WAS VISUALIZED WITH AN ESOPHAGOGASTRODUODENOSCOPY (EGD) SCOPE AND THE STENT WAS NOTED TO HAVE A HOLE. ON (B)(6) 2017, THE 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 FINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6747368 ↗