Agile™ Esophageal M00517760Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00191506006631), received between Apr 6, 2022 and Jun 24, 2025 — classified as 7 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Migration” (8 reports).

1 FDA recall record name this device's identifier, 1 still open.

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.

Recalls naming this device

1. Aug 1, 2024Class IIOpen, Classified

   WallFlexTM Esophageal Stent System and AgileTM Esophageal Over the Wire (OTW) Stent System due to the potential for delivery catheter tip detachment.

   Z-3291-2024 · Root cause: Process control · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 24, 2025Difficult to Remove; Use of Device Problem; Positioning Problem; Difficult to Remove; Use of Device Problem; Positioning Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN AGILE ESOPHAGEAL OTW STENT WAS TO BE IMPLANTED TO TREAT AN ESOPHAGEAL PERFORATION DURING AN ESOPHAGEAL STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2025. THE PATIENT'S ANATOMY WAS NOT TORTUOUS. DURING THE PROCEDURE, THE STENT WAS PLACED. UPON REMOVAL OF THE DELIVERY SYSTEM THE STENT BECAME CAUGHT ON THE DELIVERY SYSTEM. THE STENT AND DELIVERY SYSTEM WERE REMOVED TOGETHER. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT. (B)(6) 2025. IT WAS REPORTED THAT THE AGILE ESOPHAGEAL OTW STENT WAS USED TO TREAT A BENIGN ESOPHAGEAL PERFORATION. HOWEVER, PER THE AGILE ESOPHAGEAL OTW STENT SYSTEM DIRECTIONS FOR USE, 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 TO BE PLACED FOR TREATMENT OF A PERFORATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22323546 ↗
• InjuryMar 20, 2025Migration; Migration

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN AGILE ESOPHAGEAL STENT WAS IMPLANTED TO TREAT A MALIGNANT STRICTURE DURING A PROCEDURE PERFORMED ON (B)(6) 2024. IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE STENT HAD MIGRATED. NOTE: NO FURTHER INFORMATION HAS BEEN OBTAINED DESPITE GOOD FAITH EFFORTS. ***ADDITIONAL INFORMATION RECEIVED ON MARCH 28, 2025*** IT WAS REPORTED THAT THE AGILE ESOPHAGEAL STENT WAS TO BE IMPLANTED TO TREAT A 5MM POLYPOID OBSTRUCTING MASS IN THE ESOPHAGUS DURING AN UPPER GI ENDOSCOPY PROCEDURE PERFORMED ON (B)(6) 2024.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21654082 ↗
• MalfunctionFeb 20, 2025Difficult to Remove; Difficult to Remove

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN AGILE ESOPHAGEAL FULLY COVERED STENT OTW WAS TO BE IMPLANTED IN THE ESOPHAGUS TO TREAT AN ESOPHAGEAL CANCER DURING AN ESOPHAGEAL STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2025. THE PATIENT'S ANATOMY WAS NORMAL AND WAS NOT DILATED PRIOR TO STENT PLACEMENT. DURING THE PROCEDURE, THE STENT WAS ABLE TO BE DEPLOYED. HOWEVER, WHEN THE CATHETER WAS REMOVED, IT WAS NOTED THAT THE PROXIMAL END OF THE STENT WAS STILL ATTACHED TO THE CATHETER. THE STENT WAS REMOVED TOGETHER WITH THE CATHETER, AND THE PROCEDURE WAS COMPLETED WITH ANOTHER AGILE ESOPHAGEAL STENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21424952 ↗
• MalfunctionDec 26, 2024Migration; Migration

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN AGILE ESOPHAGEAL FULLY COVERED OVER-THE-WIRE STENT WAS USED DURING A PROCEDURE PERFORMED ON (B)(6) 2024. THE STENT WAS ABLE TO BE DEPLOYED SATISFACTORILY. ON (B)(6) 2024, COMPLETE DISTAL STENT MIGRATION WAS NOTED. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT. NOTE: NO FURTHER INFORMATION HAS BEEN OBTAINED DESPITE GOOD FAITH EFFORTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21021151 ↗
• InjurySep 14, 2024Migration; Migration

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN AGILE ESOPHAGEAL OTW FULLY COVERED STENT WAS IMPLANTED IN THE ESOPHAGUS TO TREAT A 36 X 40 CM MALIGNANT STRICTURE DURING AN ESOPHAGOGASTRODUODENOSCOPY (EGD) WITH STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2024. THE PATIENT'S ANATOMY WAS NOT DILATED PRIOR TO STENT PLACEMENT. ON (B)(6) 2024, THE PATIENT PRESENTED WITH CHEST/THROAT PAIN AND HAD TROUBLE SWALLOWING. SUBSEQUENTLY, THE PHYSICIAN ORDERED AN X-RAY, AND DISTAL STENT MIGRATION WAS CONFIRMED. THE STENT WAS THEN REMOVED USING A RAPTOR GRASPING DEVICE AND ANOTHER AGILE PARTIALLY COVERED STENT WAS PLACED TO COMPLETE THE PROCEDURE.

  Patient problems: Dysphagia/ Odynophagia; Pain

  MAUDE report 20219141 ↗
• InjuryJul 25, 2024Migration; Device Stenosis; Migration; Device Stenosis

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN AGILE ESOPHAGEAL FULLY COVERED OTW STENT WAS IMPLANTED IN THE ESOPHAGUS TO TREAT A MALIGNANT STRICTURE DURING AN ESOPHAGOGASTRODUODENOSCOPY (EGD) WITH STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2024. ON (B)(6) 2024, THE PATIENT PRESENTED TO THE EMERGENCY DEPARTMENT (ED) WITH DYSPHAGIA. THE STENT WAS CHECKED, AND A COMPLETE PROXIMAL STENT MIGRATION WAS NOTED. ADDITIONALLY, STENT OCCLUSION OCCURRED DUE TO FOOD IMPACTION. SUBSEQUENTLY, THE STENT WAS REMOVED USING A RAT-TOOTH FORCEPS AND ANOTHER STENT WAS PLACED TO COMPLETE THE PROCEDURE.

  Patient problems: Dysphagia/ Odynophagia

  MAUDE report 19831848 ↗
• InjuryJul 16, 2024Migration; Migration

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN AGILE ESOPHAGEAL OTW FULLY COVERED STENT WAS IMPLANTED IN THE ESOPHAGUS AND STOMACH TO TREAT A MALIGNANT ULCERATING MASS IN THE DISTAL ESOPHAGUS DURING AN UPPER GASTROINTESTINAL (GI) ENDOSCOPY PROCEDURE PERFORMED ON (B)(6) 2024. ON (B)(6) 2024, POST STENT PLACEMENT, IT WAS NOTED THAT THE STENT HAD MIGRATED CAUSING THE PATIENT TO BE UNABLE TO EAT. THE STENT WAS SUBSEQUENTLY REMOVED USING GRASPERS. THE PATIENT'S CONDITION WAS REPORTED TO BE WELL.

  Patient problems: Dysphagia/ Odynophagia; Feeding Problem

  MAUDE report 19750951 ↗
• InjuryFeb 13, 2024Migration; Migration

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN AGILE ESOPHAGEAL FULLY COVERED STENT WAS IMPLANTED IN THE DISTAL ESOPHAGUS TO TREAT A 7CM MALIGNANT STENOSIS DURING AN UPPER GASTROINTESTINAL ENDOSCOPY PROCEDURE PERFORMED ON (B)(6) 2023. THE PATIENT'S ANATOMY WAS TORTUOUS AND WAS NOT DILATED PRIOR TO STENT PLACEMENT. THE STENT WAS ABLE TO BE DEPLOYED SUCCESSFULLY. ON APRIL 25, 2023, DURING A ROUTINE FOLLOW-UP, A COMPUTED TOMOGRAPHY (CT) SCAN WAS PERFORMED, AND IT WAS NOTED THAT THE STENT MIGRATED. THE STENT WAS REMOVED USING FORCEPS. THE PATIENT'S INDICATION WAS RESOLVED AT THE TIME OF MIGRATION. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18695737 ↗
• InjuryFeb 12, 2024Migration; Migration

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN AGILE ESOPHAGEAL OTW FULLY COVERED STENT WAS IMPLANTED TO TREAT AN ESOPHAGOFISTULA IN THE ESOPHAGUS DURING AN UPPER GASTROINTESTINAL ENDOSCOPY PROCEDURE PERFORMED ON (B)(6) 2023. ON JANUARY 9, 2024, IT WAS CONFIRMED THROUGH A LATERAL CHEST RADIOGRAPH THAT THE AGILE ESOPHAGEAL STENT HAD PARTIALLY MIGRATED IN THE DISTAL PART OF THE ANATOMY. A STENT REMOVAL PROCEDURE WAS PERFORMED ON THE SAME DAY, AND THE STENT WAS REMOVED FROM THE PATIENT WITH FORCEPS. A FISTULA WAS REPORTED TO HAVE BEEN NOTED ON THE PATIENT; HOWEVER, THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Fistula

  MAUDE report 18690270 ↗
• InjuryApr 6, 2022Difficult or Delayed Positioning; Positioning Problem; Migration; Difficult or Delayed Positioning; Positioning Problem; Migration

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6)2022 THAT AN AGILE ESOPHAGEAL OTW FULLY COVERED STENT WAS IMPLANTED TO TREAT A 5CM MALIGNANT STRICTURE IN THE DISTAL ESOPHAGUS DURING AN ESOPHAGOGASTRODUODENOSCOPY (EGD) WITH STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6)2022. REPORTEDLY, THE PATIENT'S ANATOMY WAS TORTUOUS AND WAS DILATED PRIOR TO STENT PLACEMENT. DURING THE PROCEDURE, THE STENT WAS DIFFICULT TO DEPLOY AND WAS FULLY DEPLOYED MORE DISTAL. THE STENT WAS SUCCESSFULLY REPOSITIONED INTO ITS CORRECT POSITION WITH FORCEPS AND THE PROCEDURE WAS COMPLETED. HOWEVER, A DAY AFTER STENT PLACEMENT, IT WAS NOTED THAT THE STENT MIGRATED INTO THE STOMACH. THE STENT WAS REMOVED AND A COMPETITOR'S PERCUTANEOUS ENDOSCOPIC GASTROSTOMY (PEG) TUBE AND A REPLACEMENT GASTROSTOMY TUBE WERE PLACED FOR PALLIATIVE CARE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. IN THE PHYSICIAN'S ASSESSMENT, THE PATIENT'S ANATOMY AND PROGRESSION OF DISEASE STATE CONTRIBUTED TO THE DIFFICULT DEPLOYMENT. IN THE PHYSICIAN'S ASSESSMENT, THE STENT MIGRATED DUE TO THE STENT DILATING THE STRICTURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14025129 ↗