Ultraflex™ Esophageal NG M00513710Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 08714729716136), received between Aug 20, 2021 and Jul 24, 2025 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Activation, Positioning or Separation Problem” (2 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 24, 2025Activation, Positioning or Separation Problem; Adverse Event Without Identified Device or Use Problem; Activation, Positioning or Separation Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ULTRAFLEX ESOPHAGEAL NG STENT WAS TO BE IMPLANTED IN THE MID-ESOPHAGUS TO TREAT ESOPHAGEAL CANCER CAUSING A 4 CENTIMETER STENOSIS DURING AN ESOPHAGEAL STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2025. THE PATIENT'S ANATOMY WAS NOT DILATED PRIOR TO STENT PLACEMENT. DURING THE PROCEDURE, THE STENT FAILED TO BE RELEASED. THE HANDLE COULD NO LONGER BE MOVED PARTWAY THROUGH. A PARTIAL RECAPTURE COULD NOT BE PERFORMED EITHER. A STENT-IN-STENT RELEASE WAS ATTEMPTED; HOWEVER, THE SUTURE WAS TOO STIFF, PREVENTING DEPLOYMENT. THE STENT WAS TEMPORARILY REMOVED FOR EVALUATION, BUT REINSERTION WAS NO LONGER POSSIBLE. THE STENT WAS REMOVED PARTIALLY DEPLOYED FROM THE PATIENT AND THE PROCEDURE WAS COMPLETED WITH ANOTHER SAME MODEL STENT. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22600301 ↗
• MalfunctionJan 12, 2022Break; Unraveled Material; Activation, Positioning or Separation Problem; Material Deformation; Break; Unraveled Material; Activation, Positioning or Separation Problem; Material Deformation

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ULTRAFLEX ESOPHAGEAL NG DISTAL RELEASE UNCOVERED STENT WAS TO BE IMPLANTED TO TREAT A 6-7 CM MALIGNANT ESOPHAGEAL STRICTURE DURING A PROCEDURE PERFORMED ON (B)(6) 2021. DURING THE PROCEDURE, THE STENT WAS ATTEMPTED TO BE DEPLOYED BUT THE BLACK DEPLOYMENT SUTURE GOT KNOTTED. THE STENT WAS PARTIALLY DEPLOYED ON THE DELIVERY SYSTEM WHEN IT WAS REMOVED FROM THE PATIENT. 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 END OF THE PROCEDURE WAS REPORTED TO BE STABLE. NOTE: THIS COMPLAINT HAS BEEN DEEMED MDR REPORTABLE BASED ON THE INVESTIGATION RESULT OF STENT DETACHED AND STENT UNRAVELED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13236191 ↗
• InjuryAug 20, 2021Migration; Migration

  BOSTON SCIENTIFIC BECAME AWARE OF AN EVENT INVOLVING AN ULTRAFLEX ESOPHAGEAL NG DISTAL RELEASE UNCOVERED STENT THROUGH THE ARTICLE "CASE STUDY ON AIRWAY STENT PLACEMENT FOR EMERGENCY AIRWAY DUE TO ADVANCED ESOPHAGEAL CANCER" BY DR. MIKA TAKASHIMA, ET AL. ACCORDING TO THE LITERATURE, AN ULTRAFLEX ESOPHAGEAL NG DISTAL RELEASE UNCOVERED STENT WAS IMPLANTED IN THE LEFT MAIN BRONCHUS TO TREAT A RESPIRATORY TRACT STENOSIS DUE TO ADVANCED ESOPHAGEAL CANCER DURING A STENT PLACEMENT PROCEDURE PERFORMED BETWEEN 2019 AND 2020. ON AN UNKNOWN DATE, 1300 DAYS AFTER STENT PLACEMENT, IT WAS NOTED THAT THE STENT GRADUALLY MOVED TO THE CENTRAL SIDE OF THE BRONCHUS. REPORTEDLY, PNEUMONIA WAS OBSERVED DUE TO STUBBORN COUGH AND SPUTUM DISCHARGED DIFFICULTY. THE STENT WAS REMOVED FROM THE PATIENT. NOTE: BOSTON SCIENTIFIC HAS BEEN UNABLE TO OBTAIN ADDITIONAL INFORMATION REGARDING THE EVENT TO DATE, DESPITE GOOD FAITH EFFORTS.

  Patient problems: Pneumonia

  MAUDE report 12347773 ↗