Agile™ Esophageal M00517450Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 08714729973072), received between Dec 23, 2021 and Aug 20, 2025 — classified as 2 deaths, 3 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Migration” (3 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 20, 2025Migration; Migration

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN AGILE ESOPHAGEAL TTS FULLY COVERED STENT WAS IMPLANTED DURING A PROCEDURE PERFORMED ON (B)(6) 2025. IT WAS REPORTED THAT A COMPLETE DISTAL STENT MIGRATION OCCURRED ON (B)(6) 2025. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. NO ADDITIONAL INFORMATION HAS BEEN OBTAINED DESPITE GOOD FAITH EFFORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22854359 ↗
• DeathOct 25, 2023Use of Device Problem; Adverse Event Without Identified Device or Use Problem; Use of Device Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN AGILE ESOPHAGEAL FULLY COVERED STENT WAS IMPLANTED IN THE ESOPHAGUS TO TREAT A BENIGN STRICTURE DURING AN ESOPHAGOGASTRODUODENOSCOPY (EGD) WITH STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2023. THE PATIENT'S ANATOMY WAS TORTUOUS. ON (B)(6) 2023, DURING EMERGENT FOLLOW-UP, THE PATIENT PRESENTED WITH BLEEDING AROUND THE DISTAL FLANGE OF THE STENT. THE PHYSICIAN BELIEVED THAT THE DISTAL FLANGE OF THE STENT ERODED THE MUCOSA WHICH RESULTED IN BLEEDING REQUIRING HOSPITALIZATION. SUBSEQUENTLY, THE STENT WAS REMOVED, AND EPINEPHRINE WAS ADMINISTERED TO STOP THE BLEEDING. LATER THAT DAY, RECURRENCE OF BLEEDING OCCURRED; HOWEVER, THE PATIENT REFUSED ADDITIONAL CARE. ON THE SAME DATE, THE PATIENT PASSED AWAY DUE TO BLOOD LOSS. IN THE PHYSICIAN'S ASSESSMENT, THE RELATIONSHIP BETWEEN THE STENT AND THE PATIENT'S DEATH IS UNKNOWN. NOTE: IT WAS REPORTED THAT THE AGILE ESOPHAGEAL STENT WAS IMPLANTED TO TREAT A BENIGN 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

  Patient problems: Erosion; Hemorrhage/Blood Loss/Bleeding

  MAUDE report 18004270 ↗
• DeathMay 10, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON APRIL 13, 2023, THAT AN AGILE ESOPHAGEAL TTS FULLY COVERED STENT WAS IMPLANTED IN THE ESOPHAGUS TO TREAT A 5 CM METASTATIC DISTAL ESOPHAGEAL STRICTURE DURING AN ESOPHAGOGASTRODUODENOSCOPY (EGD) WITH STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2023. A COMPUTERIZED TOMOGRAPHY (CT) SCAN AND MAGNETIC RESONANCE IMAGING (MRI) WERE TAKEN PRE-PROCEDURE. DURING THE PROCEDURE, THE AGILE ESOPHAGEAL STENT WAS SUCCESSFULLY IMPLANTED. THE PATIENT WAS REPORTED TO BE STABLE AFTER THE PROCEDURE. THE PATIENT REPORTED THAT HE WAS ABLE TO SWALLOW AND FELT BETTER POST PROCEDURE AND REQUESTED TO HAVE A DRINK. PATIENT WAS ADVISED BY THE ATTENDING PHYSICIAN NOT TO TAKE ANY FLUIDS POST PROCEDURE TO ALLOW THE STENT TO COMPLETELY EXPAND. AT AROUND 18:00, THE PATIENT WAS UNABLE TO BREATHE AND WAS NOTED TO HAVE ASPIRATED BLOOD. A DNR (DO NOT RESUSCITATE) WAS IN PLACE. NO FURTHER ACTION WAS TAKEN. SUBSEQUENTLY, THE PATIENT EXPIRED.

  Patient problems: Aspiration/Inhalation; Hemorrhage/Blood Loss/Bleeding

  MAUDE report 16902272 ↗
• InjuryApr 12, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON MARCH 23, 2023 THAT AN AGILE ESOPHAGEAL FULLY COVERED STENT WAS IMPLANTED IN THE ESOPHAGUS DURING AN ESOPHAGOGASTRODUODENOSCOPY (EGD) WITH STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2023. THE PATIENT'S ANATOMY WAS NOT DILATED PRIOR TO STENT PLACEMENT. DURING A SCHEDULED FOLLOW-UP, TWO WEEKS POST STENT PLACEMENT, THE PATIENT PRESENTED WITH SYMPTOMS RELATED TO PERFORATION. SUBSEQUENTLY, THE AGILE ESOPHAGEAL STENT WAS REMOVED AND ANOTHER STENT WAS PLACED TO ADDRESS THE PERFORATION.

  Patient problems: Perforation

  MAUDE report 16724278 ↗
• MalfunctionSep 8, 2022Difficult to Remove; Positioning Problem; Difficult to Remove; Positioning Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2022 THAT AN AGILE ESOPHAGEAL STENT WAS TO BE IMPLANTED IN THE ESOPHAGUS TO TREAT AN APPROXIMATELY 4-5 CM ESOPHAGEAL TUMOR DURING AN ESOPHAGOGASTRODUODENOSCOPY (EGD) PROCEDURE PERFORMED ON (B)(6) 2022. THE PATIENT'S ANATOMY WAS NOT TORTUOUS AND WAS NOT DILATED PRIOR TO STENT PLACEMENT. DURING THE PROCEDURE, THE AGILE ESOPHAGEAL STENT WAS SUCCESSFULLY DEPLOYED UNDER FLUOROSCOPIC GUIDE. UPON REMOVAL OF THE AGILE DELIVERY SYSTEM, THE STENT SUTURE LOOP GOT CAUGHT ON THE DELIVERY SYSTEM AND THE AGILE ESOPHAGEAL STENT MOVED OUT FROM THE TARGET LOCATION. THE AGILE ESOPHAGEAL STENT WAS REMOVED TOGETHER WITH THE DELIVERY SYSTEM THROUGH THE PATIENT'S MOUTH. 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 15384976 ↗
• InjuryJun 10, 2022Migration; Migration

  IIT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2022 THAT AN AGILE ESOPHAGEAL STENT WAS IMPLANTED TO TREAT A 2 CM MALIGNANT, TIGHT, PINHOLE STRICTURE IN THE MID ESOPHAGUS DUE TO AN ESOPHAGEAL SQUAMOUS CELL CARCINOMA DURING AN ESOPHAGOGASTRODUODENOSCOPY (EGD) PROCEDURE PERFORMED ON (B)(6) 2022. ON (B)(6) 2022, POST STENT PLACEMENT, DURING A NORMAL FOLLOW-UP, THE PATIENT PRESENTED WITH DYSPHASIA. IMAGING WAS PERFORMED AND SHOWED THE STENT HAD MIGRATED PROXIMALLY ABOVE THE STRICTURE. ANOTHER EGD PROCEDURE WAS PERFORMED, THE STENT WAS REMOVED FROM THE PATIENT WITH RAT TOOTH FORCEPS AND ANOTHER WALLFLEX ESOPHAGEAL STENT WAS IMPLANTED TO COMPLETE THE PROCEDURE. THERE WAS NO OTHER INTERVENTION OR TREATMENT REQUIRED TO ADDRESS THE PATIENT'S DYSPHASIA. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Dysphasia

  MAUDE report 14654762 ↗
• InjuryDec 23, 2021Migration; Migration

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2021 THAT AN AGILE ESOPHAGEAL STENT WAS IMPLANTED IN THE LOWER ESOPHAGUS DURING AN ESOPHAGOGASTRODUODENOSCOPY (EGD) PROCEDURE PERFORMED ON (B)(6) 2021. REPORTEDLY, THE PATIENT'S ANATOMY WAS NOT TORTUOUS AND WAS NOT DILATED PRIOR TO STENT PLACEMENT. DURING A SCHEDULED CHECK UP PER PROTOCOL ON (B)(6) 2021, THE STENT MIGRATED FROM THE LOWER ESOPHAGUS TO THE STOMACH. THE STENT WAS REMOVED FROM THE PATIENT USING RAT TOOTH FORCEPS AND THE PHYSICIAN NOTES THAT THE STRICTURE WAS HALF RESOLVED. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13080444 ↗