Ultraflex™ Esophageal NG M00514210Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 08714729121206), received between Dec 7, 2016 and Jan 11, 2023 — classified as 2 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Activation Failure” (3 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryJan 11, 2023Activation Failure; Activation Failure

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2022, THAT AN ULTRAFLEX ESOPHAGEAL NG DISTAL RELEASE COVERED STENT WAS TO BE IMPLANTED TO TREAT A 33CM-44CM MALIGNANT ESOPHAGEAL STRICTURE DURING AN ESOPHAGOGASTRODUODENOSCOPY (EGD) PROCEDURE PERFORMED ON (B)(6) 2021. THE PATIENT'S ANATOMY WAS TORTUOUS AND WAS NOT DILATED PRIOR TO STENT PLACEMENT. DURING THE PROCEDURE, THE ULTRAFLEX ESOPHAGEAL STENT DID NOT FULLY EXPAND. THE ULTRAFLEX ESOPHAGEAL STENT WAS SUCCESSFULLY REMOVED FROM THE PATIENT WITH FORCEPS. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION AFTER THE PROCEDURE WAS REPORTED BE UNCHANGED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16139408 ↗
• MalfunctionNov 18, 2020Break; Activation, Positioning or Separation Problem; Material Deformation; Break; Activation, Positioning or Separation Problem; Material Deformation

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ULTRAFLEX ESOPHAGEAL STENT WAS TO BE IMPLANTED TO TREAT A NEOPLASTIC LESION IN THE ESOPHAGUS TRACT DURING A GASTROSCOPY WITH STENT PLACEMENT PROCEDURE. REPORTEDLY, THE PATIENT'S ANATOMY WAS NOT TORTUOUS AND WAS NOT DILATED PRIOR TO STENT PLACEMENT. ACCORDING TO THE COMPLAINANT, DURING STENT DEPLOYMENT, THE STENT DEPLOYMENT SUTURE KNOTTED AND BROKE. THE STENT WAS REMOVED FROM THE PATIENT PARTIALLY DEPLOYED ON THE DELIVERY SYSTEM AND THE PROCEDURE WAS COMPLETED WITH 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. 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 10858607 ↗
• MalfunctionAug 26, 2020Activation, Positioning or Separation Problem; Material Deformation; Activation, Positioning or Separation Problem; Material Deformation

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ULTRAFLEX ESOPHAGEAL NG DISTAL RELEASE COVERED STENT WAS TO BE IMPLANTED TO TREAT AN ESOPHAGEAL CANCER DURING A STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2020. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE STENT WAS UNABLE TO DEPLOY. THE STENT WAS PARTIALLY DEPLOYED ON THE DELIVERY SYSTEM WHEN IT WAS REMOVED FROM THE PATIENT. 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 STABLE. NOTE: THIS EVENT HAS BEEN DEEMED AN MDR-REPORTABLE EVENT BASED ON THE INVESTIGATION RESULTS WHICH REVEALED THAT THE STENT LOOPS WERE BENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10454964 ↗
• MalfunctionApr 19, 2017Activation Failure; Activation Failure

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2017 THAT AN ULTRAFLEX¿ ESOPHAGEAL DISTAL RELEASE COVERED STENT WAS IMPLANTED IN THE ESOPHAGUS TO TREAT A 5 CM NEOPLASTIC CARDIA STENOSIS, 39 TO 43 CM FROM THE ORAL FISSURE, DURING AN ESOPHAGOGASTRODUODENOSCOPY (EGD) PROCEDURE PERFORMED ON (B)(6) 2017. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY DEPLOYED THE ULTRAFLEX ESOPHAGEAL STENT IN THE CARDIA STENOSIS; HOWEVER, THE DISTAL END OF THE STENT DID NOT FULLY EXPAND. THE PHYSICIAN NOTED THAT THE STENOSIS WAS OPENED AND KEPT THE STENT 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 GOOD.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6503883 ↗
• InjuryMar 7, 2017Activation Failure; Activation Failure

  NOTE: THIS MANUFACTURER REPORT PERTAINS TO ONE OF TWO DEVICES USED IN THE SAME PROCEDURE. REFER TO MANUFACTURER REPORT # 3005099803-2017-00605 AND 3005099803-2017-00606 FOR THE OTHER ASSOCIATED DEVICE INFORMATION. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2017 THAT A WALLFLEX ESOPHAGEAL FULLY COVERED RMV AND AN ULTRAFLEX ESOPHAGEAL DISTAL RELEASE STENTS WERE TO BE USED TO TREAT A MALIGNANT STRICTURE IN THE ESOPHAGUS DURING AN ESOPHAGEAL METALLIC STENTING PROCEDURE PERFORMED ON (B)(6) 2017. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE PHYSICIAN WAS ABLE TO FULLY DEPLOY THE WALLFLEX ESOPHAGEAL STENT (THE SUBJECT TO MFR REPORT # 3005099803-2017-00605) INSIDE THE PATIENT; HOWEVER, THE STENT FAILED TO EXPAND. THE PHYSICIAN REMOVED THE STENT USING RAT TOOTH FORCEPS AND DEPLOYED THE ULTRAFLEX ESOPHAGEAL STENT (THE SUBJECT TO MFR REPORT # 3005099803-2017-00606) BUT THE SAME ISSUE OCCURRED. THE ULTRAFLEX ESOPHAGEAL STENT WAS REMOVED USING RAT TOOTH FORCEPS 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 STA

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6385103 ↗
• MalfunctionDec 9, 2016Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(4) 2016 THAT AN ULTRAFLEX¿ ESOPHAGEAL STENT WAS TO BE USED TO TREAT A 6 CM MALIGNANT STRICTURE IN THE MIDDLE THIRD PART OF THE ESOPHAGUS DURING A THERAPEUTIC GASTROSCOPY PROCEDURE PERFORMED ON (B)(6) 2016. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE PHYSICIAN STARTED DEPLOYING THE STENT BUT THE STENT WOULD NOT DEPLOY. THE PHYSICIAN REMOVED THE ENTIRE DEVICE FROM THE PATIENT AND NOTED THAT THE STENT DEPLOYMENT SUTURE BROKE. THE PROCEDURE WAS COMPLETED WITH A WALLFLEX 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 6157584 ↗
• MalfunctionDec 7, 2016Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON NOVEMBER 14, 2016 THAT AN ULTRAFLEX ESOPHAGEAL DISTAL RELEASE STENT WAS TO BE USED TO TREAT A 10CM MALIGNANT STRICTURE IN THE MID ESOPHAGUS DURING AN ESOPHAGOGASTRODUODENOSCOPY WITH STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2016. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE PHYSICIAN STARTED DEPLOYING THE STENT WHEN THE DEPLOYMENT SUTURE GOT TANGLED WITH THE DISTAL END OF THE STENT. THE PARTIALLY DEPLOYED STENT WAS REMOVED FROM THE PATIENT AND THE PROCEDURE WAS COMPLETED USING ANOTHER ULTRAFLEX ESOPHAGEAL DISTAL RELEASE STENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE STABLE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6152232 ↗