Ultraflex Esophageal NGRecalls & reported problems across all models

We found 15 models of Ultraflex Esophageal NG by Boston Scientific Corporation in the FDA's device registry (GUDID). Together they are named in 239 adverse event reports in the FDA's MAUDE database, received between Nov 23, 2016 and Sep 17, 2026 — classified as 1 death, 90 injuries, 148 malfunctions.

The most frequently reported specific device problem is “Activation, Positioning or Separation Problem” (109 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported Ultraflex Esophageal NG problems

Ultraflex Esophageal NG models

15 models, most reported first. Each model has its own page with its reports, recalls and device details.

• Ultraflex™ Esophageal NG M00513740

  PROSTHESIS, ESOPHAGEAL
  49 reports
• Ultraflex™ Esophageal NG M00513730

  PROSTHESIS, ESOPHAGEAL
  47 reports
• Ultraflex™ Esophageal NG M00513750

  PROSTHESIS, ESOPHAGEAL
  1 death37 reports
• Ultraflex™ Esophageal NG M00513840

  PROSTHESIS, ESOPHAGEAL
  24 reports
• Ultraflex™ Esophageal NG M00514250

  PROSTHESIS, ESOPHAGEAL
  17 reports
• Ultraflex™ Esophageal NG M00513850

  PROSTHESIS, ESOPHAGEAL
  13 reports
• Ultraflex™ Esophageal NG M00514240

  PROSTHESIS, ESOPHAGEAL
  13 reports
• Ultraflex™ Esophageal NG M00513860

  PROSTHESIS, ESOPHAGEAL
  12 reports
• Ultraflex™ Esophageal NG M00514200

  PROSTHESIS, ESOPHAGEAL
  11 reports
• Ultraflex™ Esophageal NG M00514210

  PROSTHESIS, ESOPHAGEAL
  7 reports
• Ultraflex™ Esophageal NG M00513710

  PROSTHESIS, ESOPHAGEAL
  3 reports
• Ultraflex™ Esophageal NG M00513700

  PROSTHESIS, ESOPHAGEAL
  2 reports
• Ultraflex™ Esophageal NG M00513830

  PROSTHESIS, ESOPHAGEAL
  2 reports
• Ultraflex™ Esophageal NG M00513720

  PROSTHESIS, ESOPHAGEAL
  1 report
• Ultraflex™ Esophageal NG M00513800

  PROSTHESIS, ESOPHAGEAL
  1 report

Recent Ultraflex Esophageal NG adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• InjurySep 17, 2026Migration

  It was reported to Boston Scientific Corporation that an Ultraflex Esophageal NG Covered Distal Release Stent was implanted in the esophagus to treat a 6 cm malignant esophageal stenosis during an Endoscopic Retrograde Cholangiopancreatography Procedure (ERCP) performed on (b)(6) 2026. The patient's anatomy was tortuous and was dilated prior to stent placement. On (b)(6) 2026, post stent placement, it was noted under imaging examination that the stent had migrated. The stent was removed using biopsy forceps, and another of the same device was used to complete the procedure.There were no patient complications reported as a result of this event and the patient condition after the procedure was reported to be stable.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50805009 ↗
• MalfunctionSep 11, 2026Unraveled Material

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50739871 ↗
• MalfunctionSep 10, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50722979 ↗
• MalfunctionSep 10, 2026Activation, Positioning or Separation Problem; Material Integrity Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50717104 ↗
• MalfunctionAug 11, 2026Positioning Failure; Material Deformation

  It was reported to Boston Scientific Corporation that an Ultraflex Esophageal NG Distal Release Covered Stent was to be implanted in the esophagus to treat an esophageal stenosis during a stent placement procedure performed on (b)(6), 2026. During the procedure, it was noted that the stent was kinked, and the wire could not be pulled. The device was removed, and another of the same device was used to complete the procedure.There were no patient complications reported as a result of this event and the patient condition was reported to be stable.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50202713 ↗
• MalfunctionJul 10, 2026Activation, Positioning or Separation Problem; Activation Failure

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ULTRAFLEX ESOPHAGEAL STENT WAS TO BE IMPLANTED TO TREAT ESOPHAGEAL CANCER IN THE ESOPHAGUS DURING AN ESOPHAGEAL STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2026. DURING THE PROCEDURE, THE STENT WAS FAILED TO FULLY EXPAND AFTER DEPLOYMENT. ANOTHER ULTRAFLEX ESOPHAGEAL STENT WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT AND THE PATIENT CONDITION FOLLOWING THE PROCEDURE WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25786553 ↗
• MalfunctionJun 30, 2026Premature Activation; Activation, Positioning or Separation Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ULTRAFLEX ESOPHAGEAL NG DISTAL COVERED STENT WAS TO BE IMPLANTED TO TREAT ESOPHAGEAL STENOSIS DURING A STENT IMPLANTATION PROCEDURE PERFORMED ON (B)(6) 2026. DURING THE PROCEDURE, THE STENT WAS REPORTED TO HAVE DISLODGED OUTSIDE THE PATIENT. ANOTHER ULTRAFLEX ESOPHAGEAL STENT WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. THE PATIENT CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25673470 ↗
• MalfunctionJun 24, 2026Deformation Due to Compressive Stress; Activation, Positioning or Separation Problem; Difficult to Advance

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ULTRAFLEX ESOPHAGEAL NG DISTAL COVERED STENT WAS TO BE IMPLANTED TO TREAT AN APPROXIMATELY 10 CM ESOPHAGEAL STRICTURE IN THE ESOPHAGUS DURING AN ESOPHAGEAL STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2026. THE PATIENT'S ANATOMY WAS TORTUOUS AND WAS NOT DILATED PRIOR TO STENT PLACEMENT. DURING THE PROCEDURE, THE STENT WAS ADVANCED OVER A GUIDEWIRE; HOWEVER, RESISTANCE WAS ENCOUNTERED WHILE ADVANCING THE DELIVERY SYSTEM. DESPITE PRIOR DILATION OF THE STRICTURE, THE CATHETER BECAME BENT, PREVENTING SUCCESSFUL STENT DEPLOYMENT. THE STENT WAS REMOVED PARTIALLY DEPLOYED ON THE DELIVERY SYSTEM, AND THE PROCEDURE WAS COMPLETED USING A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25607922 ↗
• 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 ↗
• MalfunctionApr 20, 2026Activation, Positioning or Separation Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ULTRAFLEX ESOPHAGEAL STENT WAS ATTEMPTED TO BE IMPLANTED TO TREAT ESOPHAGEAL STENOSIS IN THE ESOPHAGUS DURING AN ENDOSCOPIC PLACEMENT OF ESOPHAGEAL STENT PROCEDURE PERFORMED ON (B)(6) 2026. DURING THE PROCEDURE, AFTER DEPLOYMENT, THE DEVICE FAILED TO EXPAND FULLY, WHICH AFFECTED THE PROCEDURE. THE PROCEDURE WAS COMPLETED WITH ANOTHER ULTRAFLEX ESOPHAGEAL STENT. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. THE PATIENT CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24932893 ↗
• MalfunctionApr 7, 2026Device Misassembled During Manufacturing /Shipping; Adverse Event Without Identified Device or Use Problem; Positioning Problem; Activation Failure

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ULTRAFLEX ESOPHAGEAL STENT WAS ATTEMPTED TO BE IMPLANTED TO THE ESOPHAGUS TO TREAT A SEVERE STRICTURE DURING AN ESOPHAGEAL STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2026. DURING THE PROCEDURE, THE STENT WAS DISLOCATED AND COULD NOT CROSS THE STENOSIS LESION. THE PROCEDURE WAS COMPLETED USING A DIFFERENT DEVICE. THERE WAS NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24811403 ↗
• MalfunctionMar 9, 2026Activation, Positioning or Separation Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A ULTRAFLEX ESOPHAGEAL STENT WAS ATTEMPTED TO BE IMPLANTED IN THE ESOPHAGUS TO TREAT A 6CM ESOPHAGEAL STENOSIS CAUSED BY A MALIGNANT NECROTIC TUMOR DURING AN ESOPHAGEAL STENT IMPLANTATION PROCEDURE PERFORMED ON (B)(6) 2026. THE ANATOMY OF THE PATIENT WAS TORTUROUS AND WAS DILATED PRIOR TO STENT PLACEMENT. DURING THE PROCEDURE, THE STENT COULD NOT BE SUCCESSFULLY DEPLOYED. THE DEVICE WAS SUBSEQUENTLY REMOVED FROM THE PATIENT, AT WHICH TIME THE STENT WAS OBSERVED TO BE PARTIALLY DEPLOYED. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE OF THE SAME MODEL. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24548010 ↗
• MalfunctionFeb 27, 2026Activation, Positioning or Separation Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ULTRAFLEX ESOPHAGEAL STENT WAS TO BE IMPLANTED INTO THE ESOPHAGUS TO TREAT A SEVERE STENOSIS CAUSED BY A MALIGNANT TUMOR DURING AN ESOPHAGEAL STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2026. THE ANATOMY OF THE PATIENT WAS NOT TORTUOUS AND WAS DILATED PRIOR TO STENT PLACEMENT. DURING PROCEDURE, THE DEVICE WAS UNABLE TO BE DEPLOYED NORMALLY. WHEN THE STENT WAS REMOVED FROM THE PATIENT IT WAS PARTIALLY DEPLOYED. THE PROCEDURE WAS COMPLETED USING ANOTHER OF THE SAME DEVICE. THERE WAS NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24470644 ↗
• MalfunctionFeb 5, 2026Break; Activation, Positioning or Separation Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ULTRAFLEX ESOPHAGEAL STENT WAS TO BE IMPLANTED TO THE ESOPHAGUS TO TREAT AN 8CM SIZE OF LESION CAUSED BY MALIGNANCY DURING AN ENDOSCOPY GUIDED ESOPHAGEAL STENTING PROCEDURE PERFORMED ON (B)(6) 2026. THE ANATOMY OF THE PATIENT WAS NOT TORTUOUS AND WAS NOT DILATED PRIOR TO STENT PLACEMENT. DURING PROCEDURE, WHILE PLACING THE STENT, THE STENT DEPLOYMENT SUTURE THREAD BROKE DOWN WHILE PULLING THE THREAD. WHEN THE STENT WAS REMOVED FROM THE PATIENT, IT WAS PARTIALLY DEPLOYED. DUE TO THIS EVENT, THE STENT WAS NOT IMPLANTED. INITIALLY, THE PROCEDURE WAS NOT COMPLETED. HOWEVER, ON THE DAY AFTER, THE PROCEDURE WAS COMPLETED USING A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THE PROCEDURE. THERE WAS NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24274265 ↗
• MalfunctionJan 27, 2026Activation, Positioning or Separation Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ULTRAFLEX ESOPHAGEAL STENT WAS TO BE IMPLANTED IN THE ESOPHAGUS TO TREAT AN 8CM STENOSIS CAUSED BY CANCER DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2025. THE PATIENT'S ANATOMY WAS TORTUOUS AND WAS DILATED PRIOR TO STENT PLACEMENT. DURING THE PROCEDURE, THE STENT WAS REMOVED FROM THE PATIENT PARTIALLY COVERED WITH THE STENT-DEPLOYMENT SUTURE. THE PROCEDURE WAS THEN COMPLETED USING ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24196056 ↗

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