Agile™ Esophageal M00517400Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 08714729973027), received between Apr 7, 2021 and Nov 25, 2024 — classified as 3 injuries, 1 malfunction.

The most frequently reported specific device problem is “Premature Activation” (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. How this data works · Data updated Oct 13, 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.

• InjuryNov 25, 2024Premature Activation; Use of Device Problem; Premature Activation; Use of Device Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN AGILE ESOPHAGEAL FULLY COVERED STENT WAS TO BE IMPLANTED IN THE ESOPHAGUS TO TREAT SEVERE DYSPHAGIA SECONDARY TO ANASTOMOTIC STRICTURE DURING A STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2024. THE PATIENT'S ANATOMY WAS NOT TORTUOUS AND WAS NOT DILATED PRIOR TO STENT PLACEMENT. DURING THE PROCEDURE, THE STENT WAS DEPLOYED BEFORE REACHING THE "POINT OF NO RETURN" MARKER. THE STENT WAS POSITIONED DISTALLY AT THE SITE OF THE STRICTURE AND WAS REMOVED WITH RETRIEVAL FORCEPS. THE PROCEDURE WAS COMPLETED WITH ANOTHER AGILE ESOPHAGEAL STENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. NOTE: IT WAS REPORTED THAT THE STENT WAS TO BE IMPLANTED TO TREAT SEVERE DYSPHAGIA SECONDARY TO ANASTOMOTIC STRICTURE. HOWEVER, PER THE AGILE ESOPHAGEAL FULLY COVERED STENT SYSTEM INSTRUCTIONS FOR USE (IFU), THE STENT IS INTENDED FOR MAINTAINING ESOPHAGEAL LUMINAL PATENCY IN ESOPHAGEAL STRICTURES CAUSED BY INTRINSIC AND/OR EXTRINSIC MALIGNANT TUMORS, AND OCCLUSION OF CONCURRENT ESOPHAGEAL FISTULAS. THE DEVICE IS NOT INDICATED FOR THE TREATMENT OF SEVERE DYSPHAGIA SECONDARY TO ANASTOMOTIC STRICTURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20775540 ↗
• MalfunctionSep 26, 2023Difficult to Remove; Difficult to Remove

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN AGILE ESOPHAGEAL STENT WAS TO BE IMPLANTED TO TREAT A 2CM MALIGNANT STRICTURE IN THE UPPER ESOPHAGUS DURING AN ESOPHAGOGASTRODUODENOSCOPY (EGD) PROCEDURE PERFORMED ON (B)(6) 2023. THE PATIENT'S ANATOMY WAS NOT TORTUOUS AND WAS NOT DILATED PRIOR TO STENT PLACEMENT. DURING THE PROCEDURE, THE STENT WAS FULLY DEPLOYED BUT GOT CAUGHT ON THE DELIVERY SYSTEM DURING REMOVAL, WHICH RESULTED IN THE STENT MOVING OUT OF ITS POSITION. THE STENT WAS REMOVED ALONG WITH THE DELIVERY SYSTEM. THE PROCEDURE WAS COMPLETED USING ANOTHER AGILE ESOPHAGEAL STENT. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17818603 ↗
• InjurySep 14, 2023Premature Activation; Material Deformation; Positioning Problem; Premature Activation; Material Deformation; Positioning Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN AGILE ESOPHAGEAL STENT WAS TO BE IMPLANTED TO TREAT AN ANASTOMATIC STRICTURE IN THE ESOPHAGUS DURING AN ESOPHAGEAL STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2023. DURING THE PROCEDURE, THE STENT PREMATURELY DEPLOYED BEFORE THE DISTAL HANDLE WAS COMPLETELY PULLED BACK, WHICH CAUSED THE STENT TO BECOME DEFORMED AND MIGRATE INTO THE PATIENT'S STOMACH. THE STENT WAS REMOVED, AND THE PHYSICIAN COMPLETED THE PROCEDURE BY ADMINISTERING STEROIDS AND USING A CRE BALLOON. THE PATIENT WILL BE RESCHEDULED FOR ANOTHER STENT PLACEMENT PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17744275 ↗
• InjuryApr 7, 2021Adverse Event Without Identified Device or Use Problem; Migration; Adverse Event Without Identified Device or Use Problem; Migration

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON MARCH 15, 2021 THAT AN AGILE ESOPHAGEAL FULLY COVERED STENT WAS IMPLANTED TO TREAT A LESS THAN 6CM MALIGNANT STRICTURE IN THE ESOPHAGUS DURING AN ESOPHAGOGASTRODUODENOSCOPY (EGD) WITH STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2020. POST-STENT PLACEMENT THE PATIENT UNDERWENT RADIATION. REPORTEDLY, THE PATIENT'S ANATOMY WAS TORTUOUS AND WAS NOT DILATED PRIOR TO STENT PLACEMENT. ON MARCH 08, 2021, DURING EMERGENT FOLLOW-UP, THE PATIENT PRESENTED WITH TRACHEOESOPHAGEAL FISTULA (TEF) AND DISCOMFORT. THE TEF STARTED AT THE DISTAL END OF THE STENT. CONSEQUENTLY, THE STENT WAS REMOVED FROM THE PATIENT USING RAT-TOOTH FORCEPS AND A NON-BSC DEVICE WAS IMPLANTED OVER THE TEF TO COMPLETE THE PROCEDURE. IN THE PHYSICIAN'S ASSESSMENT THE DISCOMFORT AND THE TEF WERE RELATED TO THE DISTAL END OF THE STENT AND THE RADIATION TREATMENT. IT WAS REPORTED THAT AN IMAGE SHOWED THAT THE AGILE ESOPHAGEAL STENT MIGRATED IN THE AIRWAY.

  Patient problems: Discomfort; Fistula

  MAUDE report 11627301 ↗