Ultraflex™ Esophageal NG M00513850Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 08714729716075), received between Apr 24, 2018 and Dec 20, 2023 — classified as 4 injuries, 9 malfunctions.

The most frequently reported specific device problem is “Activation, Positioning or Separation Problem” (8 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.

• InjuryDec 20, 2023Adverse Event Without Identified Device or Use Problem; Positioning Problem; Adverse Event Without Identified Device or Use Problem; Positioning Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ULTRAFLEX ESOPHAGEAL NG PROXIMAL COVERED STENT WAS TO BE IMPLANTED IN THE MIDDLE THIRD OF THE ESOPHAGUS TO TREAT MALIGNANT STRICTURE SECONDARY TO ESOPHAGEAL CANCER DURING AN ESOPHAGEAL STENT IMPLANTATION PROCEDURE PERFORMED ON (B)(6) 2023. THE PATIENT'S ANATOMY WAS TIGHT AND WAS NOT DILATED PRIOR TO STENT PLACEMENT. DURING THE PROCEDURE, THE STENT WAS DIFFICULT TO POSITION, AND IT WAS DEPLOYED NEAR THE PHARYNX. 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. THE PATIENT'S CONDITION FOLLOWING THE PROCEDURE WAS REPORTED TO BE STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18367045 ↗
• MalfunctionMay 9, 2023Positioning Failure; Failure to Advance; Material Deformation; Positioning Failure; Failure to Advance; Material Deformation

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2023, THAT AN ULTRAFLEX ESOPHAGEAL NG PROXIMAL RELEASE COVERED STENT WAS IMPLANTED TO TREAT ESOPHAGEAL STENOSIS DUE TO ESOPHAGEAL CANCER DURING AN ESOPHAGEAL STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2023. THE PATIENT ANATOMY WAS TORTUOUS AND NOT DILATED PRIOR TO STENT PLACEMENT, DURING THE PROCEDURE, THE DEVICE COULD NOT BE ADVANCED THROUGH THE STENOSIS. DILATION WAS ATTEMPTED AND A NEW MANEUVER WAS PERFORMED TO IMPLANT THE STENT. HOWEVER, THE STENT WAS UNABLE TO CROSS THE STENOSIS EVEN AFTER SEVERAL ATTEMPTS AND THE DISTAL PART OF THE DELIVERY SHAFT WAS NOTED TO BE BENT. THE STENT WAS REMOVED FROM THE PATIENT FULLY COVERED BY THE STENT DEPLOYMENT SUTURE, AND THE PROCEDURE WAS NOT COMPLETED DUE TO THIS EVENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT CONDITION FOLLOWING THE PROCEDURE WAS REPORTED TO BE STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16896525 ↗
• MalfunctionMar 31, 2023Break; Activation, Positioning or Separation Problem; Break; Activation, Positioning or Separation Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON MARCH 18, 2023 THAT AN ULTRAFLEX ESOPHAGEAL PROXIMAL COVERED STENT WAS USED TO TREAT A 7CM MALIGNANT MIDDLE ESOPHAGEAL CARCINOMA DURING A STENT PLACEMENT PROCEDURE PERFORMED ON MARCH 17, 2023. THE PATIENT'S ANATOMY WAS NOT TORTUOUS AND WAS DILATED PRIOR TO STENT PLACEMENT PROCEDURE. DURING THE PROCEDURE, THE BLACK DEPLOYMENT SUTURE STOPPED UNRAVELLING AND THE STENT WAS UNABLE TO FULLY DEPLOY. THE STENT WAS PARTIALLY DEPLOYED WHEN IT WAS REMOVED FROM THE PATIENT. THE PROCEDURE WAS CANCELLED AND WAS RESCHEDULED AFTER A WEEK. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. **ADDITIONAL INFORMATION RECEIVED ON OCTOBER 10, 2023 AND OCTOBER 15, 2023** THE STENT WAS PARTIALLY RELEASED AND THE BLACK DEPLOYMENT SUTURE WAS BROKEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16657213 ↗
• InjurySep 15, 2022Material Separation; Material Separation

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON AUGUST 22, 2022, THAT AN ULTRAFLEX ESOPHAGEAL NG PROXIMAL RELEASE COVERED STENT WAS IMPLANTED TO TREAT A STRICTURE DUE TO ESOPHAGEAL CANCER DURING AN ESOPHAGEAL STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6), 2022. DURING THE PROCEDURE, THE ULTRAFLEX ESOPHAGEAL STENT WAS SUCCESSFULLY DEPLOYED. HOWEVER, IT WAS NOTED THAT THE SILASTIC BAND ON THE DELIVERY SYSTEM FELL INSIDE THE PATIENT. THE SILASTIC BAND WAS REMOVED USING FORCEPS. THE STENT REMAINED IMPLANTED AND THE PROCEDURE WAS COMPLETED WITH THIS DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15433028 ↗
• MalfunctionJan 26, 2022Positioning Failure; Activation, Positioning or Separation Problem; Positioning Failure; Activation, Positioning or Separation Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ULTRALFEX ESOPHAGEAL PROXIMAL RELEASE COVERED STENT WAS TO BE IMPLANTED TO TREAT AN ESOPHAGEAL CANCER DURING AN ESOPHAGEAL STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2021. DURING THE PROCEDURE, THE STENT COULD NOT BE DEPLOYED. THE STENT WAS FULLY COVERED BY THE DEPLOYMENT SUTURE WHEN IT WAS REMOVED FROM THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER ULTRAFLEX ESOPHAGEAL STENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED DUE TO THIS EVENT. THE PATIENT CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE STABLE. NOTE: THIS COMPLAINT HAS BEEN DEEMED MDR REPORTABLE BASED ON THE INVESTIGATION RESULT OF STENT PARTIALLY DEPLOYED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13361560 ↗
• MalfunctionJan 13, 2022Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON DECEMBER 21, 2021 THAT AN ULTRAFLEX ESOPHAGEAL COVERED PROXIMAL RELEASE STENT WAS TO BE IMPLANTED TO TREAT A 5-6 CM MALIGNANT STRICTURE DUE TO ESOPHAGEAL CANCER DURING AN ESOPHAGEAL STENTING PROCEDURE PERFORMED ON (B)(6) 2021. 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 PARTIALLY DEPLOYED ON THE DELIVERY SYSTEM AND ANOTHER ULTRAFLEX ESOPHAGEAL STENT WAS USED TO COMPLETE THE PROCEDURE. 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 13250980 ↗
• MalfunctionSep 13, 2021Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12459669 ↗
• MalfunctionSep 1, 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 AN ESOPHAGEAL CANCER DURING A STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6), 2021. DURING THE PROCEDURE, WHEN THE STENT WAS ATTEMPTED TO BE DEPLOYED, RESISTANCE WAS FELT AND THE STENT WAS UNABLE TO DEPLOY. THE STENT WAS REMOVED FROM THE PATIENT PARTIALLY DEPLOYED ON THE DELIVERY SYSTEM AND THE PROCEDURE WAS CANCELLED AND RESCHEDULED TO USE 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 12408938 ↗
• MalfunctionJun 23, 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 TO TREAT CANCER IN THE LOWER ESOPHAGUS DURING AN UPPER ENDOSCOPY WITH ESOPHAGEAL STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2020. ACCORDING TO THE COMPLAINANT, DURING PREPARATION, POST PATIENT SEDATION, IT WAS NOTICED THAT THE STENT WAS PARTIALLY DEPLOYED WITHOUT MANIPULATION. REPORTEDLY, THERE WERE NO ISSUES NOTED WITH THE PACKAGING. 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. A PHOTO OF THE DEVICE PROVIDED BY THE COMPLAINANT BEFORE THE PROCEDURE SHOWS THE STENT WAS PARTIALLY DEPLOYED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10184094 ↗
• MalfunctionMar 26, 2019Activation, Positioning or Separation Problem; Material Deformation; Activation, Positioning or Separation Problem; Material Deformation

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON MARCH 2, 2019 THAT AN ULTRAFLEX ESOPHAGEAL NG PROXIMAL RELEASE COVERED STENT WAS TO BE USED TO TREAT A MALIGNANT STRICTURE IN THE ESOPHAGUS DURING AN ESOPHAGEAL STENTING PROCEDURE PERFORMED ON (B)(6) 2019. REPORTEDLY, THE PATIENT'S ANATOMY WAS NOT DILATED PRIOR TO STENT PLACEMENT. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE STENT WAS UNABLE TO BE FULLY DEPLOYED AS THE DEPLOYMENT SUTURE WAS KNOTTED. THE PARTIALLY DEPLOYED STENT WAS REMOVED AND ANOTHER ULTRAFLEX ESOPHAGEAL STENT WAS PLACED TO COMPLETE THE PROCEDURE. THERE WERE NO WERE PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8453829 ↗
• MalfunctionOct 25, 2018Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2018 THAT AN ULTRAFLEX ESOPHAGEAL PROXIMAL RELEASE COVERED STENT WAS TO BE USED TO TREAT A MALIGNANT STRICTURE IN THE ESOPHAGUS DURING ESOPHAGEAL STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2018. REPORTEDLY, THE PATIENT'S ANATOMY WAS NOT TORTUOUS AND WAS NOT DILATED PRIOR TO STENT PLACEMENT. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE THE STENT WAS ABLE TO CROSS THE STENOSIS ALONG WITH THE GUIDEWIRE. HOWEVER, IT WAS REPORTED THAT GREAT RESISTANCE WAS MET DURING DEPLOYMENT, AND THE STENT WAS DEPLOYED PARTIALLY ON THE DELIVERY SYSTEM. THE STENT WAS REMOVED 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 FOLLOWING THE PROCEDURE WAS REPORTED TO BE STABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8005618 ↗
• InjuryOct 15, 2018Migration; Migration

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2018 THAT AN ULTRAFLEX ESOPHAGEAL NG PROXIMAL RELEASE COVERED STENT WAS IMPLANTED TO TREAT A MALIGNANT STRICTURE IN THE DISTAL ESOPHAGUS DURING A STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2018. REPORTEDLY, THE PATIENT'S ANATOMY WAS NOT TORTUOUS AND WAS NOT DILATED PRIOR TO STENT PLACEMENT. ACCORDING TO THE COMPLAINANT, 50 DAYS POST STENT PLACEMENT, THE PATIENT EXPERIENCED DYSPHAGIA. DURING A GASTROSCOPY PROCEDURE, THE PHYSICIAN NOTED THAT THE STENT COVER WAS PARTIALLY DETACHED FROM THE STENT. THE DETACHED COVER WAS REMOVED WITH A BIOPSY FORCEPS. REPORTEDLY, THE STENT REMAINS IMPLANTED AND THE PHYSICIAN WAS COMFORTABLE LEAVING THE STENT IN PLACE. THE PATIENT CONDITION FOLLOWING THE PROCEDURE WAS REPORTED TO BE STABLE. THE PATIENT'S DYSPHAGIA WAS NOTED TO HAVE RESOLVED.

  Patient problems: Dysphagia/ Odynophagia

  MAUDE report 7965757 ↗
• InjuryApr 24, 2018Difficult to Remove; Unraveled Material; Material Integrity Problem; Difficult to Remove; Unraveled Material; Material Integrity Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2018 THAT AN ULTRAFLEX ESOPHAGEAL NG PROXIMAL RELEASE COVERED STENT HAD BEEN IMPLANTED SIX WEEKS PRIOR TO (B)(6) 2018 TO TREAT AN IATROGENIC PERFORATION IN THE ESOPHAGUS CAUSED DURING A PREVIOUS ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE. ACCORDING TO THE COMPLAINANT, SIX WEEKS POST STENT PLACEMENT ON (B)(6) 2018, THE PATIENT EXPERIENCED DISCOMFORT WHICH PROMPTED THE PHYSICIAN TO CHECK THE ULTRAFLEX ESOPHAGEAL STENT. DURING THIS CHECK OF THE STENT, A FISTULA WAS NOTED AT THE PROXIMAL END OF THE STENT. ON (B)(6) 2018, A STENT REMOVAL PROCEDURE WAS PERFORMED. DURING THE PROCEDURE, THERE WAS DIFFICULTY REMOVING THE STENT AND IT BECAME UNRAVELED. THE STENT COVER WAS ALSO NOTED TO BE DAMAGED AT ONE END. THE STENT WAS ABLE TO BE REMOVED AND THE PATIENT UNDERWENT AN ESOPHAGOGRAM TEST. PER THE PHYSICIAN, THE TEST RESULTS WERE GOOD AND REVEALED NO ABNORMALITIES. IT IS UNKNOWN HOW THE FISTULA WAS TREATED BUT PER THE PHYSICIAN, EVERYTHING HAS HEALED AND THE PATIENT DOES NOT HAVE ANY OF THE PAST SYMPTOMS OR FISTULA GROWTH. THE PHYSICIAN PERFORMED THE FIRST DILATION ON (B)(6) 2018. NOTE: ACCORDING TO THE COMPLAINANT

  Patient problems: Fistula

  MAUDE report 7454900 ↗