Agile™ Esophageal M00517460Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 08714729973089), received between Nov 23, 2021 and Aug 19, 2026 — classified as 2 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Break” (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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 19, 2026Device-Device Incompatibility; Positioning Problem

  Note: This report pertains to an Agile Esophageal Stent and Overstitch NXT used during the same procedure.It was reported to Boston Scientific Corporation that an Agile Esophageal Fully Covered TTS stent was attempted to be implanted during an Esophagogastroduodenoscopy (EGD) procedure performed on (b)(6) 2026. During the procedure, the Agile stent was successfully placed; however, during scope removal, the stent became caught on the OverStitch needle driver and had to be forcibly removed. The procedure was completed using another Agile Esophageal TTS stent. There were no patient complications associated with this event and the patient condition following the procedure was reported as stable.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50334618 ↗
• InjuryJan 30, 2025Migration; Migration

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN AGILE ESOPHAGEAL FULLY COVERED STENT TTS WAS IMPLANTED IN THE ESOPHAGUS TO TREAT AN ESOPHAGEAL STRICTURE DURING AN ESOPHAGOGASTRODUODENOSCOPY (EGD) WITH STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2024. DURING THE PROCEDURE, THE STENT WAS SUCCESSFULLY DEPLOYED. THE PATIENT UNDERWENT THERAPY, AND IT WAS NOTED THAT THE STENT HAD MIGRATED. ANOTHER WALLFLEX STENT WAS PLACED, AND THE PHYSICIAN PLANS TO REMOVE THE MIGRATED STENT IN APPROXIMATELY 3 WEEKS. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21280068 ↗
• MalfunctionFeb 29, 2024Migration; Migration

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN AGILE ESOPHAGEAL FULLY COVERED STENT WAS IMPLANTED IN THE ESOPHAGUS TO TREAT A 9CM MALIGNANT STRICTURE DURING AN UPPER GASTROINTESTINAL (GI) ENDOSCOPY WITH STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2022. THE PATIENT'S ANATOMY WAS TORTUOUS AND WAS DILATED PRIOR TO STENT PLACEMENT PROCEDURE. THE STENT WAS SCHEDULED TO BE REMOVED ON (B)(6) 2022. DURING THE STENT REMOVAL PROCEDURE, IT WAS NOTED THAT THE STENT HAD COMPLETELY MIGRATED DISTALLY DUE TO STRICTURE RESOLUTION. THE STENT WAS FOUND IN THE STOMACH AND WAS REMOVED USING RAT-TOOTH FORCEPS, AND THE PROCEDURE WAS COMPLETED. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18813183 ↗
• InjuryDec 27, 2023Premature Activation; Premature Activation

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN AGILE ESOPHAGEAL FULLY COVERED STENT WAS TO BE IMPLANTED IN THE ESOPHAGUS TO TREAT AN ESOPHAGEAL STRICTURE DUE TO ESOPHAGEAL CANCER DURING AN ESOPHAGOGASTRODUODENOSCOPY (EGD) WITH STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2023. THE PATIENT'S ANATOMY WAS TORTUOUS AND WAS NOT DILATED PRIOR TO STENT PLACEMENT. DURING THE PROCEDURE, THE STENT PREMATURELY DEPLOYED. THE STENT WAS REMOVED USING RAT TOOTH FORCEPS AND ANOTHER AGILE ESOPHAGEAL STENT WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18399113 ↗
• MalfunctionMar 27, 2023Break; Positioning Failure; Material Deformation; Break; Positioning Failure; Material Deformation

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2023 THAT AN AGILE ESOPHAGEAL FULLY COVERED STENT WAS USED TO TREAT AN ESOPHAGEAL CANCER DURING AN ESOPHAGOGASTRODUODENOSCOPY (EGD) WITH STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2023. THE PATIENT'S ANATOMY WAS TIGHT AND WAS NOT DILATED PRIOR TO STENT PLACEMENT PROCEDURE. DURING THE PROCEDURE, WHEN THE STENT WAS BEING DEPLOYED, IT WAS NOTICED THAT THE OUTER BLUE SHEATH WAS KINKED. SUBSEQUENTLY, A SNAP WAS HEARD AND THE STENT WAS UNABLE TO BE FULLY DEPLOYED. THE STENT WAS RECONSTRAINED AND WAS FULLY COVERED BY THE OUTER SHEATH WHEN IT WAS REMOVED FROM THE PATIENT. THE PROCEDURE WAS NOT COMPLETED DUE TO DEVICE AVAILABILITY. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16620454 ↗
• MalfunctionNov 23, 2021Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6), 2021 THAT AN AGILE ESOPHAGEAL FULLY COVERED STENT WAS IMPLANTED IN THE ESOPAHAGUS TO TREAT AN ESOPHAGEAL STRICTURE DURING A STENT PLACEMENT PROCEDURE PERFORMED SIX MONTHS AGO. ON (B)(6) 2021, DURING A SCHEDULED STENT REMOVAL PROCEDURE, AFTER THE STENT WAS REMOVED FROM THE PATIENT WITH FORCEPS, THE PHYSICIAN NOTICED THAT THE METAL WELDS OF THE STENT WERE SEPARATED. THE STENT REMOVAL PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12863151 ↗