Ultraflex™ Esophageal NG M00514240Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 08714729716105), received between Apr 2, 2018 and Sep 10, 2026 — classified as 8 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Activation Failure” (5 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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 10, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50722979 ↗
• InjuryJun 16, 2026Activation Failure

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ULTRAFLEX ESOPHAGEAL NG PROXIMAL COVERED STENT WAS INTENDED TO BE IMPLANTED TO TREAT STENOSIS DURING AN ESOPHAGUS STENTING PROCEDURE PERFORMED ON (B)(6) 2026. DURING THE PROCEDURE, THE STENT WAS DEPLOYED BUT DID NOT FULLY EXPAND AND WAS RETRIEVED USING RECUE FORCEPS. ANOTHER ULTRAFLEX ESOPHAGEAL NG PROXIMAL COVERED 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 25520930 ↗
• InjuryJan 8, 2025Misassembled; Positioning Problem; Misassembled; Positioning Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ULTRAFLEX ESOPHAGEAL COVERED PROXIMAL RELEASE STENT WAS IMPLANTED IN THE ESOPHAGUS TO TREAT A MALIGNANT TUMOR DURING A STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2024. THE PATIENT'S ANATOMY WAS NOT DILATED PRIOR TO STENT PLACEMENT. DURING THE PROCEDURE, THE RADIOPAQUE MARKERS DID NOT INDICATE THE EXACT PLACE WHERE THE COVERAGE OF THE STENT WAS AFTER FULL DEPLOYMENT. THE STENT WAS 2CM BELOW THE MARKERS AND WAS NOT COVERING THE STENOSIS. THE PHYSICIAN THEN USED RESCUE FORCEPS TO ADJUST THE STENT, AND THE PROCEDURE WAS COMPLETED. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21105735 ↗
• MalfunctionApr 30, 2024Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ULTRAFLEX ESOPHAGEAL NG PROXIMAL COVERED STENT WAS TO BE IMPLANTED IN THE ESOPHAGUS TO TREAT CANCER DURING A GASTROSCOPY PROCEDURE PERFORMED ON AN UNKNOWN DATE. THE PATIENT'S ANATOMY WAS NOT DILATED PRIOR TO STENT PLACEMENT. DURING THE PROCEDURE, THE STENT COULD NOT BE DEPLOYED. THE STENT WAS REMOVED FROM THE PATIENT PARTIALLY DEPLOYED ON THE DELIVERY SYSTEM THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. NOTE: NO FURTHER INFORMATION HAS BEEN OBTAINED DESPITE GOOD FAITH EFFORTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19215578 ↗
• InjuryFeb 15, 2023Activation Failure; Activation Failure

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2023 THAT AN ULTRAFLEX ESOPHAGEAL PROXIMAL COVERED STENT WAS TO BE IMPLANTED IN THE DISTAL ESOPHAGUS TO TREAT A 5CM MALIGNANT STENOSIS DURING A GASTROSCOPY WITH STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2023. THE PATIENTS ANATOMY WAS NOT TORTUOUS AND WAS NOT DILATED PRIOR TO STENT PLACEMENT. DURING THE PROCEDURE, THE ULTRAFLEX ESOPHAGEAL STENT WAS DEPLOYED IN THE PATIENT; HOWEVER, THE PROXIMAL END OF THE STENT WAS UNABLE TO EXPAND. AN ATTEMPT TO DILATE THE STENT WITH ENDOSCOPE WAS PERFORMED BUT THE STENT WAS STILL UNABLE TO EXPAND. THE STENT WAS REMOVED WITH FORCEPS AND ANOTHER ULTRAFLEX ESOPHAGEAL 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 16379409 ↗
• InjuryOct 14, 2022Activation Failure; Activation Failure

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2022, THAT AN ULTRAFLEX ESOPHAGEAL NG PROXIMAL RELEASE COVERED STENT WAS IMPLANTED IN THE ESOPHAGUS TO TREAT AN 8CM MALIGNANT STRICTURE DURING AN ESOPHAGOGASTRODUODENOSCOPY (EGD) WITH STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2021. THE PATIENT'S ANATOMY WAS TORTUOUS AND WAS DILATED PRIOR TO STENT PLACEMENT. ON (B)(6) 2021, POST STENT PLACEMENT, THE PATIENT PRESENTED HEMATEMESIS AND HEMOGLOBIN DROP. CONSEQUENTLY, A REPEAT ESOPHAGOGASTRODUODENOSCOPY (EGD) PROCEDURE WAS PERFORMED, AND IT WAS FOUND THAT THE ULTRAFLEX ESOPHAGEAL STENT WAS UNABLE TO EXPAND AND A STENT EROSION HEMORRHAGE AT THE DISTAL END WAS NOTED. THE ULTRAFLEX ESOPHAGEAL STENT WAS REMOVED FROM THE PATIENT WITH FORCEPS AND THE BLEEDING WAS RESOLVED ON ITS OWN AND THE PROCEDURE WAS COMPLETED. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO HAVE IMPROVED.

  Patient problems: Anemia; Hemorrhage/Blood Loss/Bleeding; Vomiting

  MAUDE report 15609398 ↗
• MalfunctionAug 10, 2021Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON JULY 20, 2021 THAT AN ULTRAFLEX ESOPHAGEAL NG PROXIMAL RELEASE COVERED STENT WAS TO BE IMPLANTED FOR RECANALIZATION OF THE ESOPHAGUS LUMEN TO TREAT A MALIGNANT ESOPHAGEAL STENOSIS DURING A GASTROSCOPY WITH STENT PLACEMENT PROCEDURE PERFORMED ON AN UNKNOWN DATE. REPORTEDLY, THE PATIENT'S ANATOMY WAS TORTUOUS AND WAS NOT DILATED PRIOR TO STENT PLACEMENT. DURING THE PROCEDURE, THE BLACK DEPLOYMENT SUTURE LOOSENED CAUSING A PARTIAL STENT RELEASE WHEN THE DEVICE WAS ADVANCED THROUGH THE STENOSIS. THE STENT WAS REMOVED FROM THE PATIENT PARTIALLY COVERED BY THE STENT DEPLOYMENT SUTURE AND THE PROCEDURE WAS NOT COMPLETED AS ANOTHER OF THE SAME STENT WAS UNAVAILABLE. 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 12304031 ↗
• InjuryJan 8, 2021Activation Failure; Activation Failure

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON DECEMBER 18, 2020 THAT AN ULTRAFLEX ESOPHAGEAL NG PROXIMAL RELEASE COVERED STENT WAS TO BE IMPLANTED TO TREAT AN ESOPHAGEL STRICTURE DURING A DILATION WITH STENT PLACEMENT PROCEDURE PERFORMED ON AN UNKNOWN DATE. REPORTEDLY, THE PATIENT'S ANATOMY WAS NOT DILATED PRIOR TO STENT PLACEMENT. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE STENT COULD NOT OPEN PROPERLY. THE STENT WAS REMOVED FROM THE PATIENT WITH A RADIAL JAW4 FORCEPS. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT STENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. NOTE: A PHOTO OF THE COMPLAINT DEVICE DURING THE PROCEDURE WAS PROVIDED BY THE COMPLAINANT AND IT SHOWS THAT THE STENT DID NOT FULLY EXPAND.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 11142791 ↗
• MalfunctionJan 7, 2021Positioning Failure; Material Deformation; Positioning Failure; Material Deformation

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON OCTOBER 12, 2020 THAT AN ULTRAFLEX ESOPHAGEAL NG PROXIMAL RELEASE COVERED STENT WAS TO BE IMPLANTED IN THE ESOPHAGUS TO TREAT AN ESOPHAGEAL STENOSIS DURING STENTING PROCEDURE PERFORMED ON (B)(6) 2020. ACCORDING TO THE COMPLAINANT, THE STENT FAILED TO DEPLOY. REPORTEDLY, THE PROCEDURE WAS COMPLETED WITH ANOTHER ULTRAFLEX ESOPHAGEAL STENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. NOTE: THIS EVENT HAS BEEN DEEMED AN MDR REPORTABLE EVENT BASED ON INVESTIGATION RESULT WHICH REVEALED THE STENT LOOPS WERE BENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 11131845 ↗
• InjuryJan 28, 2020Activation Failure; Activation Failure

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON JANUARY 05, 2020 THAT AN ULTRAFLEX ESOPHAGEAL NG PROXIMAL RELEASE COVERED STENT WAS TO BE USED TO TREAT A 5-CM MALIGNANT STRICTURE IN THE MID-PART OF THE ESOPHAGUS DURING ENDOSCOPY PROCEDURE ON (B)(6) 2020. REPORTEDLY, THE PATIENT'S ANATOMY WAS NOT TORTUOUS BUT WAS CONSIDERABLY TIGHT AND WAS NOT DILATED PRIOR TO STENT PLACEMENT. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE STENT WAS ABLE TO BE DEPLOYED; HOWEVER, THE STENT FAILED TO EXPAND TO ITS EXPECTED DIAMETER AS IT DID NOT TOUCH THE ESOPHAGUS WALL. THE STENT WAS REMOVED WITH A BIOPSY FORCEPS. 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 9639735 ↗
• InjuryDec 6, 2019Break; Positioning Problem; Break; Positioning Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2019 THAT AN ULTRAFLEX ESOPHAGEAL NG PROXIMAL RELEASE COVERED STENT WAS TO BE USED TO TREAT AN ESOPHAGEAL TUMOR DURING AN ESOPHAGEAL METAL STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2019. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE PHYSICIAN GRASPED THE GREEN RETENTION SUTURE TO ADJUST THE POSITION OF THE STENT, AND THE STENT SUTURE BROKE. REPORTEDLY, THE STENT WAS REMOVED FROM THE PATIENT AND ANOTHER ULTRAFLEX ESOPHAGEAL STENT WAS PLACED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A REULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9430709 ↗
• MalfunctionSep 28, 2018Activation, Positioning or Separation Problem; Material Deformation; Activation, Positioning or Separation Problem; Material Deformation

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2018 THAT A 23X10 ULTRAFLEX ESOPHAGEAL PROXIMAL RELEASE COVERED STENT WAS TO BE USED ON AN UNKNOWN PROCEDURE PERFORMED ON (B)(6) 2018. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE STENT DEPLOYMENT SUTURE GOT ENTANGLED. THE DEVICE WAS REMOVED FROM THE PATIENT PARTIALLY DEPLOYED AND A 23X12 ULTRAFLEX ESOPHAGEAL STENT WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7917978 ↗
• InjuryApr 2, 2018Material Integrity Problem; Material Integrity Problem

  NOTE: THIS MANUFACTURER REPORT PERTAINS TO ONE OF TWO DEVICES USED IN THE SAME PATIENT. REFER TO MANUFACTURER REPORT # 3005099803-2018-01061 AND 3005099803-2018-01062 FOR THE ASSOCIATED DEVICE INFORMATION. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(4) 2018 THAT TWO ULTRAFLEX ESOPHAGEAL NG PROXIMAL RELEASE COVERED STENTS HAD BEEN IMPLANTED TO TREAT A MALIGNANT STRICTURE CONCURRENT WITH AN ESOPHAGEAL FISTULA DURING TWO STENT PLACEMENT PROCEDURES. ACCORDING TO THE COMPLAINANT, ON (B)(6) 2018, THE FIRST ULTRAFLEX STENT (THE SUBJECT OF THIS REPORT) WAS SUCCESSFULLY DEPLOYED INSIDE THE PATIENT. HOWEVER, ON (B)(6) 2018, THE PATIENT PRESENTED SYMPTOMS ASSOCIATED WITH ESOPHAGEAL FISTULA WHICH PROMPTED THE PHYSICIAN TO CHECK THE STENT. IT WAS NOTED THAT THE STENT COVER WAS DAMAGED AND THE FISTULA REMAINED OPEN. THE PHYSICIAN REMOVED THE FIRST STENT WITH FORCEPS AND A SECOND ULTRAFLEX ESOPHAGEAL NG PROXIMAL RELEASE COVERED STENT (THE SUBJECT OF REPORT# 3005099803-2018-01062) WAS IMPLANTED ON THE SAME TARGET SITE. REPORTEDLY, ON (B)(6) 2018, THE PATIENT WAS NOT WELL DUE TO THE SAME REASON; THE STENT COVER WAS DAMAGED AND THE FISTULA WAS STILL OPEN. ON THE SAME DAY, THE SECOND STEN

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7390548 ↗