Agile™ Esophageal M00517440Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 08714729973065), received between May 7, 2021 and Jul 9, 2026 — classified as 1 death, 3 injuries.

The most frequently reported specific device problem is “Positioning 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• DeathJul 9, 2026Use of Device Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN AGILE ESOPHAGEAL OTW WAS IMPLANTED IN THE RECTUM DURING AN ENDOSCOPIC SUBMUCOSAL DISSECTION (ESD) PROCEDURE PERFORMED ON (B)(6) 2026. DURING THE PROCEDURE, THE AGILE STENT WAS SUCCESSFULLY IMPLANTED. HOWEVER, IT WAS REPORTED THAT THE PATIENT UNDERWENT MULTIPLE PROCEDURES FOLLOWING THE ESD. SUBSEQUENTLY, THE PATIENT PASSED AWAY.

  Patient problems: Insufficient Information; Stroke/CVA

  MAUDE report 25767029 ↗
• InjuryAug 22, 2023Difficult or Delayed Positioning; Device-Device Incompatibility; Positioning Problem; Difficult or Delayed Positioning; Device-Device Incompatibility; Positioning Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2023, THAT AN AGILE ESOPHAGEAL FULLY COVERED STENT WAS TO BE IMPLANTED IN THE DISTAL ESOPHAGUS TO TREAT A 3CM MALIGNANT STRICTURE 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 WAS PARTIALLY DEPLOYED ON THE DELIVERY SYSTEM WHEN THE HANDLE WAS FULLY RELEASED. THE PHYSICIAN ASSUMED THAT THE STENT WAS FULLY DEPLOYED AND ATTEMPTED TO REMOVE THE DELIVERY SYSTEM; CONSEQUENTLY, THE STENT BECAME STUCK IN THE DISTAL TIP OF THE SCOPE. THE STENT WAS ABLE TO BE PUSHED OUT AND WAS DEPLOYED IN AN INCORRECT LOCATION. THE STENT WAS REMOVED WITH FORCEPS AND THE PROCEDURE WAS COMPLETED WITH ANOTHER AGILE STENT OF A DIFFERENT SIZE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17596793 ↗
• InjuryOct 17, 2022Use of Device Problem; Positioning Problem; Use of Device Problem; Positioning Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2022, THAT AN AGILE ESOPHAGEAL FULLY COVERED STENT WAS TO BE IMPLANTED TO TREAT A 2CM BENIGN ANASTOMOTIC STRICTURE DURING A STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2022. THE PATIENT'S ANATOMY WAS DILATED PRIOR TO STENT PLACEMENT. DURING THE PROCEDURE, THE AGILE STENT WAS BEING ADVANCED IN A "BEND" STRICTURE AS A RESULT OF SURGICAL RESECTION. WHEN THE AGILE STENT WAS ATTEMPTED TO BE PULLED UP 1CM PROXIMALLY, THE STENT "JUMPED" PULLING THE BOTTOM PORTION OF THE AGILE STENT AND THE AGILE STENT WAS CONSEQUENTLY DEPLOYED ABOVE THE STRICTURE. THE AGILE ESOPHAGEAL STENT WAS REMOVED WITH STANDARD FORCEPS AND THE PROCEDURE WAS CANCELLED DUE TO ANOTHER OF THE SAME DEVICE WAS UNAVAILABLE. HOWEVER, THIS TIME, THE PHYSICIAN IS GOING TO USE A 10CM AGILE ESOPHAGEAL STENT INSTEAD OF A 6CM AGILE ESOPHAGEAL STENT DUE TO THE LOCATION OF THE STRICTURE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. NOTE: IT WAS REPORTED THAT THE AGILE ESOPHAGEAL STENT WAS TO BE IMPLANTED TO TREAT A 2CM BENIGN STRICTURE. PER THE INSTRUCTIONS FOR USE (IFU), "THE AGILE ESOPHAGEAL FULLY COVERED STENT SYSTEM IS INTENDED FOR MAINTAININ

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15614287 ↗
• InjuryMay 7, 2021Device Markings/Labelling Problem; Material Integrity Problem; Device Markings/Labelling Problem; Material Integrity Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2021 THAT AN AGILE ESOPHAGEAL FULLY COVERED STENT WAS TO BE IMPLANTED IN THE ESOPHAGUS TO TREAT A 4CM ESOPHAGEAL CANCER DURING AN ESOPHAGOGASTRODUODENOSCPOPY (EGD) WITH STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2021. REPORTEDLY, THE PATIENT'S ANATOMY WAS NOT TORTUOUS AND WAS NOT DILATED PRIOR TO STENT PLACEMENT. DURING THE PROCEDURE, THE STENT WAS SUCCESSFULLY DEPLOYED INSIDE THE PATIENT; HOWEVER, THE PHYSICIAN NOTICED THAT THE PROXIMAL AND DISTAL END OF THE STENT WERE NOT COVERED WITH SILICONE COATING. THE PHYSICIAN BELIEVED THAT THE STENT IMPLANTED WAS A PARTIALLY COVERED STENT RATHER THAN A FULLY COVERED STENT AS INDICATED ON THE LABEL. ADDITIONALLY, THE STENT COVER WAS DAMAGED WITH 3 TO 5 HOLES IN IT. THE STENT WAS REMOVED FROM THE PATIENT WITH GRASPING FORCEPS AND A DIFFERENT DEVICE WAS IMPLANTED 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 11793705 ↗