Ultraflex™ Esophageal NG M00513860Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 08714729716082), received between Nov 23, 2016 and Jan 12, 2024 — classified as 6 injuries, 6 malfunctions.

The most frequently reported specific device problem is “Activation, Positioning or Separation Problem” (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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• InjuryJan 12, 2024Migration; Migration

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ULTRAFLEX ESOPHAGEAL PROXIMAL RELEASE COVERED STENT WAS IMPLANTED IN THE ESOPHAGUS FOR THE TREATMENT OF A 2CM STENOSIS DUE TO ESOPHAGEAL CANCER DURING A GASTROSCOPY PROCEDURE PERFORMED ON (B)(6) 2023. THE PATIENT'S ANATOMY WAS NOT TORTUOUS AND WAS NOT DILATED PRIOR TO STENT PLACEMENT. ON SEPTEMBER 7, 2023, THE PATIENT EXPERIENCED DISTURBED PASSAGE OF SOLID FOOD AND IT WAS LATER NOTED THAT THE STENT MIGRATED. ON (B)(6) 2023, THE STENT WAS REMOVED USING BIOPSY FORCEPS. ON (B)(6) 2023, ANOTHER ULTRAFLEX ESOPHAGEAL STENT WAS IMPLANTED.

  Patient problems: Dysphagia/ Odynophagia

  MAUDE report 18506871 ↗
• InjuryMay 18, 2022Difficult or Delayed Positioning; Positioning Problem; Difficult or Delayed Positioning; Positioning Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2022 THAT AN ULTRAFLEX ESOPHAGEAL NG PROXIMAL RELEASE COVERED STENT WAS USED TO TREAT AN ESOPHAGEAL STRICTURE DURING AN OESOPHAGO-GASTRO-DUODENOSCOPY (OGD) WITH STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2022. REPORTEDLY, THE PATIENT'S ANATOMY WAS NOT TORTUOUS AND WAS NOT DILATED PRIOR TO STENT PLACEMENT. DURING THE PROCEDURE, THE STENT DEPLOYMENT SUTURE COULD NOT BE PULLED OUT AND IT WAS NOTICED THROUGH IMAGING THAT THE STENT WAS DEPLOYED AT THE INCORRECT LOCATION. THE STENT WAS REMOVED FROM THE PATIENT WITH 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 Clinical Signs, Symptoms or Conditions

  MAUDE report 14428369 ↗
• InjuryDec 8, 2021Failure to Advance; Material Twisted/Bent; Positioning Problem; Activation Failure; Failure to Advance; Material Twisted/Bent; Positioning Problem; Activation Failure

  THIS REPORT PERTAINS TO ONE OF TWO DEVICES USED DURING THE SAME PROCEDURE. REFER TO MANUFACTURER REPORT # 3005099803-2021-06336 AND 3005099803-2021-06337 FOR THE ASSOCIATED DEVICE INFORMATION. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2021 THAT AN ULTRAFLEX ESOPHAGEAL NG PROXIMAL RELEASE COVERED STENT WAS TO BE IMPLANTED TO TREAT A 12 CM MALIGNANT ESOPHAGEAL STENOSIS DURING A GASTROSCOPY PROCEDURE PERFORMED ON (B)(6) 2021. REPORTEDLY, THE PATIENT'S ANATOMY WAS TIGHT AND WAS NOT DILATED PRIOR TO STENT PLACEMENT. DURING THE PROCEDURE, THERE WAS DIFFICULTY ADVANCING THE DELIVERY SYSTEM OF A 15CM ULTRAFLEX ESOPHAGEAL STENT (SUBJECT OF THIS REPORT) THROUGH THE STRICTURE. THE DISTAL PART OF THE DELIVERY SYSTEM WAS BENT AND THE STENT WAS DEPLOYED IN AN INCORRECT LOCATION. IT WAS OBSERVED UNDER DIRECT VISUALIZATION WITH A PEDIATRIC GASTROSCOPE THAT THE STENT DID NOT FULLY EXPAND. THE STENT WAS REMOVED FROM THE PATIENT USING A RE-USABLE GRASPING FORCEPS. A 10 CM ULTRAFLEX ESOPHAGEAL STENT (THE SUBJECT OF MFR. REPORT # 3005099803-2021-06337) WAS ATTEMPTED TO BE DEPLOYED, BUT SIMILAR PROBLEMS OCCURRED; THE DELIVERY SYSTEM HAD DIFFICULTY ADVANCING THROUGH THE STRICTURE, THE DI

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12960100 ↗
• MalfunctionDec 8, 2021Failure to Advance; Material Twisted/Bent; Positioning Problem; Activation Failure; Failure to Advance; Material Twisted/Bent; Positioning Problem; Activation Failure

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2021 THAT AN ULTRAFLEX ESOPHAGEAL NG PROXIMAL RELEASE COVERED STENT WAS TO BE IMPLANTED TO TREAT A MALIGNANT ESOPHAGEAL STENOSIS DURING A GASTROSCOPY PROCEDURE PERFORMED ON (B)(6) 2021. DURING THE PROCEDURE, THERE WAS DIFFICULTY ADVANCING THE DELIVERY SYSTEM THROUGH THE STRICTURE. THE DISTAL PART OF THE DELIVERY SYSTEM WAS BENT AND THE STENT WAS DEPLOYED IN AN INCORRECT LOCATION. IT WAS OBSERVED UNDER DIRECT VISUALIZATION WITH A PEDIATRIC GASTROSCOPE THAT THE STENT DID NOT FULLY EXPAND. THE STENT WAS REMOVED FROM THE PATIENT USING A RE-USABLE GRASPING FORCEPS AND THE PROCEDURE WAS CANCELLED. A NON-SERIOUS INJURY WAS REPORTED RELATED TO THE EVENT.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 12960099 ↗
• MalfunctionDec 7, 2021Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2021 THAT AN ULTRAFLEX ESOPHAGEAL NG PROXIMAL RELEASE COVERED STENT WAS TO BE IMPLANTED TO TREAT A 6-7CM MALIGNANT STRICTURE DUE TO ESOPHAGEAL CANCER DURING AN ESOPHAGEAL STENT IMPLANTATION 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 COULD NOT BE DEPLOYED. THE STENT WAS REMOVED FROM THE PATIENT PARTIALLY COVERED BY THE STENT DEPLOYMENT SUTURE. 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 Clinical Signs, Symptoms or Conditions

  MAUDE report 12951700 ↗
• MalfunctionNov 17, 2021Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON OCTOBER 29, 2021 THAT AN ULTRAFLEX ESOPHAGEAL NG PROXIMAL RELEASE COVERED STENT WAS TO BE IMPLANTED TO TREAT A 6-7CM MALIGNANT STRICTURE DUE TO ESOPHAGEAL CANCER DURING AN ESOPHAGEAL STENT IMPLANTATION 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 COULD NOT BE DEPLOYED. REPORTEDLY, THE STENT WAS REMOVED FROM THE PATIENT PARTIALLY COVERED BY THE STENT DEPLOYMENT SUTURE. 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 Clinical Signs, Symptoms or Conditions

  MAUDE report 12832709 ↗
• MalfunctionOct 12, 2020Break; Activation, Positioning or Separation Problem; Break; Activation, Positioning or Separation Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2020 THAT AN ULTRAFLEX ESOPHAGEAL NG PROXIMAL RELEASE COVERED STENT WAS TO BE IMPLANTED TO TREAT A MALIGNANT STRICTURE IN THE ESOPHAGUS DURING A STENTING PROCEDURE PERFORMED ON (B)(6) 2020. REPORTEDLY, THE PATIENT'S ANATOMY WAS DILATED PRIOR TO STENT PLACEMENT. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE PHYSICIAN ATTEMPTED TO DEPLOY THE STENT BY PULLING THE DEPLOYMENT SUTURE; HOWEVER, THE DEPLOYMENT SUTURE BROKE AND THE STENT FAILED TO DEPLOY. REPORTEDLY, THE STENT WAS REMOVED PARTIALLY DEPLOYED ON THE DELIVERY SYSTEM AND ANOTHER ULTRAFLEX ESOPHAGEAL STENT WAS USED 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 GOOD.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10666611 ↗
• MalfunctionJul 7, 2020Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2020 THAT AN ULTRAFLEX ESOPHAGEAL NG PROXIMAL RELEASE COVERED STENT WAS TO BE IMPLANTED IN THE ESOPHAGUS TO TREAT ESOPHAGEAL CANCER DURING AN ESOPHAGEAL STENTING PROCEDURE PERFORMED ON (B)(6) 2020. REPORTEDLY, THE PATIENT'S ANATOMY WAS NOT TORTUOUS AND WAS DILATED PRIOR TO STENT PLACEMENT. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE BLACK STENT DEPLOYMENT SUTURE COULD NOT BE COMPLETELY RELEASED AND THE STENT DID NOT FULLY DEPLOY. THE STENT WAS REMOVED FROM THE PATIENT PARTIALLY DEPLOYED ON THE DELIVERY SYSTEM 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 FINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10239011 ↗
• InjuryMar 30, 2020Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ULTRAFLEX ESOPHAGEAL NG STENT WAS IMPLANTED IN THE ESOPHAGUS DURING A STENTING PROCEDURE PERFORMED ON (B)(6), 2020. ACCORDING TO THE COMPLAINANT, POST STENT PLACEMENT, ON (B)(6), 2020 THE STENT WAS FOUND TO BE SLIGHTLY BROKEN IN THE MIDDLE. ANOTHER ULTRAFLEX ESOPHAGEAL NG STENT WAS PLACED STENT-IN-STENT TO COVER THE BROKEN PORTION OF THE STENT TO RESOLVE THE ISSUE. 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. ADDITIONAL INFORMATION RECEIVED ON (B)(6), 2020 REPORTEDLY, THE PATIENT DID NOT EXPERIENCE SYMPTOMS OR ADVERSE EVENTS RELATED TO THE STENT BREAK CAUSING THE PATIENT TO BE HOSPITALIZED. THE PATIENT WAS ALREADY HOSPITALIZED WHEN THE PHYSICIAN DISCOVERED A LEAK IN THE STENT.

  Patient problems: No Code Available

  MAUDE report 9898489 ↗
• InjuryDec 14, 2017Component Missing; Component Missing

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2017 THAT AN ULTRAFLEX ESOPHAGEAL NG PROXIMAL RELEASE COVERED STENT WAS IMPLANTED TO TREAT AN ESOPHAGEAL ANASTOMOTIC DEHISCENCE DURING A STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2017. REPORTEDLY, THE PATIENT¿S ANATOMY WAS NOT DILATED PRIOR TO STENT PLACEMENT AND THE PATIENT UNDERWENT CHEMOTHERAPY AND RADIATION PRIOR TO THE INITIAL SURGERY. ACCORDING TO THE COMPLAINANT, ON (B)(6) 2017, 8 DAYS POST STENT PLACEMENT, BILE WAS COMING OUT THROUGH THE PATIENT¿S INTUBATION TUBE, WHICH PROMPTED THE PHYSICIAN TO CHECK THE STENT. THE PHYSICIAN PERFORMED AN ESOPHAGOGASTRODUODENOSCOPY (EGD) PROCEDURE AND FOUND THAT A PART OF THE STENT COVER HAD DISAPPEARED. ACCORDING TO THE PHYSICIAN, THE STENT HAD FAILED TO RESOLVE THE DEHISCENCE AND A 4 CM BRONCHO-ESOPHAGIC FISTULA WAS NOTED. THE PATIENT WAS SENT TO URGENT SURGERY AND THE PHYSICIAN PERFORMED CERVICAL ESOPHAGECTOMY, GASTROSTOMY, AND MUSCLE PLASTY OVER THE BRONCHO-ESOPHAGIC FISTULAE. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE STABLE.

  Patient problems: Fistula

  MAUDE report 7119103 ↗
• InjuryAug 4, 2017Kinked; Kinked

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON JULY 16, 2017 THAT AN ULTRAFLEX ESOPHAGEAL PROXIMAL RELEASE COVERED STENT WAS TO BE USED TO TREAT A 12 CM STRICTURE IN THE MID-ESOPHAGUS DURING A STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2017. REPORTEDLY, THE PATIENT'S ANATOMY HAD BEEN DILATED UP TO 11 MM PRIOR TO STENT PLACEMENT. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE PHYSICIAN WAS ABLE TO DEPLOY THE STENT. HOWEVER, WHEN THE STENT WAS VISUALIZED WITH A SCOPE, THE STENT WAS NOTED TO BE BENT AND THE ESOPHAGUS WAS COMPLETELY BLOCKED. THE STENT WAS REMOVED FROM THE PATIENT AND THE PROCEDURE WAS COMPLETED WITH ANOTHER ULTRAFLEX ESOPHAGEAL STENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE STABLE. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION REGARDING THIS EVENT HAVE BEEN UNSUCCESSFUL TO DATE. SHOULD ADDITIONAL RELEVANT DETAILS BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6768581 ↗
• MalfunctionNov 23, 2016Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2016 THAT AN ULTRAFLEX ESOPHAGEAL PROXIMAL RELEASE STENT WAS TO BE USED IN THE ESOPHAGUS DURING A STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2016. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE STENT WAS ATTEMPTED TO BE DEPLOYED; HOWEVER, ONCE THE STENT WAS ALMOST FULLY DEPLOYED (75% DEPLOYED) THE STENT WAS NO LONGER ABLE TO BE RELEASED. THE PHYSICIAN SUSPECTED THAT THE DEPLOYMENT SUTURE WAS ENTANGLED. THE PARTIALLY DEPLOYED STENT WAS REMOVED FROM THE PATIENT 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 POST- PROCEDURE WAS REPORTED TO BE ¿NO PROBLEM¿.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6125387 ↗