Agile™ Esophageal M00517770Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 00191506006648), received between Nov 16, 2022 and Dec 9, 2025 — classified as 3 injuries, 8 malfunctions.

The most frequently reported specific device problem is “Difficult to Remove” (5 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• InjuryDec 9, 2025Activation Failure; Activation Failure

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN AGILE ESOPHAGEAL STENT WAS INTENDED TO BE IMPLANTED IN THE DISTAL ESOPHAGUS TO TREAT A MALIGNANT STRICTURE DURING AN ESOPHAGOGASTRODUODENOSCOPY (EGD) PERFORMED ON (B)(6) 2025. THE PATIENT'S ESOPHAGEAL ANATOMY WAS DESCRIBED AS TORTUOUS, AND NO DILATION WAS PERFORMED PRIOR TO STENT PLACEMENT. THE LESION MEASURED APPROXIMATELY 8 CM IN LENGTH AND WAS NOTED TO BE SO NARROW THAT ONLY A SLIM EGD SCOPE COULD BARELY TRAVERSE IT. DURING THE PROCEDURE, THE STENT WAS DEPLOYED FROM THE CATHETER; HOWEVER, IT DID NOT FULLY EXPAND UPON RELEASE. BECAUSE OF THE INCOMPLETE EXPANSION, THE STENT REMAINED PARTIALLY ENGAGED WITH THE DELIVERY SYSTEM AND SNAGGED ON THE CATHETER DURING WITHDRAWAL, RESULTING IN THE STENT BEING UNINTENTIONALLY PULLED OUT OF THE PATIENT. A RE-SHEATHING ATTEMPT WAS PERFORMED, BUT THE STENT CONTINUED TO CATCH ON THE CATHETER UPON EXIT. THE ISSUE PROLONGED THE PROCEDURE BY APPROXIMATELY FIFTEEN MINUTES. THE STENT WAS ULTIMATELY DEPLOYED AND REMOVED USING RESCUE RETRIEVAL FORCEPS, AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED USING A LARGER AGILE ESOPHAGEAL STENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF TH

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23753496 ↗
• InjuryNov 12, 2025Positioning Problem; Positioning Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN AGILE ESOPHAGEAL FULLY COVERED STENT OTW WAS TO BE IMPLANTED IN THE ESOPHAGUS TO TREAT A STRICTURE DURING AN ESOPHAGEAL STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, THE AGILE STENT WAS DEPLOYED AND WAS IN GOOD POSITION. HOWEVER, WITHIN A FEW MINUTES OF DEPLOYMENT, THE STENT MIGRATED INTO THE STOMACH. THE STENT WAS SUBSEQUENTLY REMOVED, AND A DIFFERENT DEVICE WAS USED 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 23536674 ↗
• MalfunctionNov 18, 2024Difficult to Remove; Difficult to Remove

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN AGILE ESOPHAGEAL OTW FULLY COVERED STENT WAS TO BE IMPLANTED IN THE ESOPHAGUS TO TREAT A MALIGNANT STRICTURE DURING AN ESOPHAGOGASTRODUODENOSCOPY (EGD) WITH 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 RETRIEVAL SUTURE GOT CAUGHT ON THE DELIVERY SYSTEM DURING AN ATTEMPTED WITHDRAWAL OF THE CATHETER. THE STENT WAS REMOVED TOGETHER WITH THE DELIVERY SYSTEM, AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20715951 ↗
• MalfunctionSep 4, 2024Migration; Migration

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN AGILE ESOPHAGEAL FULLY COVERED STENT OTW WAS IMPLANTED IN THE UPPER ESOPHAGUS TO TREAT A TRACHEOESOPHAGEAL FISTULA DURING AN ESOPHAGOGASTRODUODENOSCOPY (EGD) WITH STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2024. POST STENT PLACEMENT, ON (B)(6) 2024, AN X-RAY WAS PERFORMED AND IT REVEALED THAT THE STENT HAD MIGRATED DISTALLY FOR APPROXIMATELY 2CM. ON (B)(6) 2024, THE STENT WAS SCHEDULED TO BE REMOVED. HOWEVER, THE PATIENT WENT INTO CARDIAC ARREST AND THE PATIENT PASSED AWAY PRIOR TO STENT REMOVAL PROCEDURE. IN THE PHYSICIAN'S ASSESSMENT, THE STENT WAS NOT RELATED TO PATIENT'S DEATH.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20140853 ↗
• MalfunctionMay 15, 2023Difficult to Remove; Difficult to Remove

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2023 THAT AN AGILE ESOPHAGEAL OTW FULLY COVERED STENT WAS TO BE IMPLANTED TO TREAT A MALIGNANT STRICTURE IN THE ESOPHAGUS 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 PROCEDURE. DURING THE PROCEDURE, THE STENT WAS SUCCESSFULLY PLACED; HOWEVER, WHEN THE DELIVERY SYSTEM WAS REMOVED, THE STENT BECAME CAUGHT ON THE DELIVERY SYSTEM. SUBSEQUENTLY, THE STENT AND THE GUIDEWIRE WERE REMOVED FROM THE PATIENT ALONG WITH THE DELIVERY SYSTEM. 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 16932142 ↗
• MalfunctionJan 27, 2023Use of Device Problem; Migration; Use of Device Problem; Migration

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2023 THAT AN AGILE ESOPHAGEAL OTW FULLY COVERED STENT WAS IMPLANTED IN THE DISTAL ESOPHAGUS TO TREAT A LACERATION DURING AN ESOPHAGOGASTRODUODENOSCOPY (EGD) WITH STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2023. THE PATIENT'S ANATOMY WAS TORTUOUS. ON (B)(6) 2023, TWO DAYS POST STENT PLACEMENT, A COMPUTERIZED TOMOGRAPHY (CT) SCAN WAS PERFORMED AND IT WAS OBSERVED THAT THE AGILE ESOPHAGEAL STENT HAD COLLAPSED CLOSED TO THE LOWER ESOPHAGEAL SPHINCTER (LES). FURTHERMORE, THE PATIENT'S SYMPTOMS OF VOMITING AND NAUSEA PRIOR TO THE STENT PLACEMENT PROCEDURE HAS NOT IMPROVED. THERE WERE NO TREATMENTS/INTERVENTIONS PERFORMED AND THE AGILE ESOPHAGEAL STENT REMAINED IMPLANTED. THE PATIENT IS CURRENTLY HOSPITALIZED UNTIL BEING TRANSFERRED OUT TO A NEW FACILITY. NOTE: IT WAS REPORTED THAT THE AGILE ESOPHAGEAL OTW STENT WAS IMPLANTED TO TREAT A LACERATION. PER THE INSTRUCTIONS FOR USE (IFU), "THE AGILE ESOPHAGEAL FULLY COVERED OTW STENT SYSTEM 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 STENT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16254798 ↗
• MalfunctionJan 23, 2023Difficult to Remove; Use of Device Problem; Difficult to Remove; Use of Device Problem

  NOTE: THIS REPORT PERTAINS TO ONE OF THE TWO DEVICES USED ON THE SAME PATIENT. REFER TO MANUFACTURER REPORT NUMBER 3005099803-2023-00079 FOR THE ASSOCIATED DEVICE INFORMATION. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2023, THAT AN AGILE ESOPHAGEAL OTW FULLY COVERED STENT WAS TO BE IMPLANTED IN THE ESOPHAGUS TO TREAT AN ESOPHAGEAL TEAR 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 AGILE ESOPHAGEAL OTW FULLY COVERED STENT (THE SUBJECT OF THIS REPORT) WAS DEPLOYED USING FLUOROSCOPIC IMAGING BY PULLING THE DISTAL CATHETER ALL THE WAY TO THE PROXIMAL HANDLE UNTIL IT REACHED THE TARGET WHITE RADIOPAQUE MARKER. DURING REMOVAL, TECHNICIAN WAS HAVING DIFFICULTY REMOVING THE DELIVERY CATHETER AS TWO CELLS OF THE STENT GOT STUCK ON THE DELIVERY CATHETER WHICH CAUSED THE STENT TO BE PULLED TOGETHER WITH THE DELIVERY CATHETER. A SECOND AGILE ESOPHAGEAL OTW FULLY COVERED STENT (THE SUBJECT OF MFR. REPORT NUMBER 3005099803-2023-00079) WAS DEPLOYED; HOWEVER, DURING THE REMOVAL OF THE DELIVERY SYSTEM, THE SECOND AGILE ESOPHAGEAL STENT WAS A

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16227930 ↗
• MalfunctionJan 23, 2023Difficult to Remove; Use of Device Problem; Difficult to Remove; Use of Device Problem

  NOTE: THIS REPORT PERTAINS TO ONE OF THE TWO DEVICES USED ON THE SAME PATIENT. REFER TO MANUFACTURER REPORT NUMBER 3005099803-2023-00078 FOR THE ASSOCIATED DEVICE INFORMATION. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2023, THAT AN AGILE ESOPHAGEAL OTW FULLY COVERED STENT WAS TO BE IMPLANTED IN THE ESOPHAGUS TO TREAT AN ESOPHAGEAL TEAR 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 AGILE ESOPHAGEAL OTW FULLY COVERED STENT (THE SUBJECT OF MFR. REPORT NUMBER 3005099803-2023-00078) WAS DEPLOYED USING FLUOROSCOPIC IMAGING BY PULLING THE DISTAL CATHETER ALL THE WAY TO THE PROXIMAL HANDLE UNTIL IT REACHED THE TARGET WHITE RADIOPAQUE MARKER. DURING REMOVAL, TECHNICIAN WAS HAVING DIFFICULTY REMOVING THE DELIVERY CATHETER AS TWO CELLS OF THE STENT GOT STUCK ON THE DELIVERY CATHETER WHICH CAUSED THE STENT TO BE PULLED TOGETHER WITH THE DELIVERY CATHETER. A SECOND AGILE ESOPHAGEAL OTW FULLY COVERED STENT (THE SUBJECT OF THIS REPORT) WAS DEPLOYED; HOWEVER, DURING THE REMOVAL OF THE DELIVERY SYSTEM, THE SECOND AGILE ESOPHAGEAL STENT WAS A

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16227647 ↗
• InjuryJan 11, 2023Use of Device Problem; Migration; Use of Device Problem; Migration

  NOTE: THIS REPORT PERTAINS TO ONE OF THE TWO DEVICES USED ON THE SAME PATIENT. REFER TO MANUFACTURER REPORT# 3005099803-2022-07928 AND 005099803-2022-07929 FOR THE ASSOCIATED DEVICE INFORMATION. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON DECEMBER 29, 2022, THAT AN AGILE ESOPHAGEAL OTW FULLY COVERED STENT WAS IMPLANTED IN THE LOWER ESOPHAGUS TO TREAT A PERFORATION 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. THE PATIENT WAS REGULARLY MONITORED WITH IMAGING AFTER STENT PLACEMENT. ON DECEMBER 17, 2022, DURING A ROUTINE FOLLOW-UP, IMAGING SHOWED THE AGILE ESOPHAGEAL OTW FULLY COVERED STENT (THE SUBJECT OF THIS REPORT) HAD MIGRATED. EGD WITH STENT REPLACEMENT PROCEDURE WAS PERFORMED AND THE AGILE ESOPHAGEAL OTW FULLY COVERED STENT WAS REMOVED FROM THE PATIENT WITH FORCEPS. A SECOND AGILE ESOPHAGEAL OTW FULLY COVERED STENT (THE SUBJECT OF MFR. REPORT # 3005099803-2022-07928) WAS DEPLOYED; HOWEVER, DURING REMOVAL OF THE DELIVERY SYSTEM, THE SECOND AGILE ESOPHAGEAL STENT GOT CAUGHT ON THE DELIVERY CATHETER AND THE STENT WAS REMOVED TOGETHER WITH THE DELIVERY SYSTE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16136819 ↗
• MalfunctionJan 11, 2023Difficult to Remove; Use of Device Problem; Adverse Event Without Identified Device or Use Problem; Difficult to Remove; Use of Device Problem; Adverse Event Without Identified Device or Use Problem

  NOTE: THIS REPORT PERTAINS TO ONE OF THE TWO DEVICES USED ON THE SAME PATIENT. REFER TO MANUFACTURER REPORT# 005099803-2022-07929 FOR THE ASSOCIATED DEVICE INFORMATION. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON DECEMBER 19, 2022, THAT AN AGILE ESOPHAGEAL OTW FULLY COVERED STENT WAS IMPLANTED IN THE LOWER ESOPHAGUS TO TREAT A PERFORATION 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. THE PATIENT WAS REGULARLY MONITORED WITH IMAGING AFTER STENT PLACEMENT. ON (B)(6) 2022, DURING A ROUTINE FOLLOW-UP, IMAGING SHOWED THE AGILE ESOPHAGEAL OTW FULLY COVERED STENT (THE SUBJECT OF MFR. REPORT # 3005099803-2022-07929) HAD MIGRATED. EGD WITH STENT REPLACEMENT PROCEDURE WAS PERFORMED AND THE AGILE ESOPHAGEAL OTW FULLY COVERED STENT WAS REMOVED FROM THE PATIENT WITH FORCEPS. A SECOND AGILE ESOPHAGEAL OTW FULLY COVERED STENT (THE SUBJECT OF THIS REPORT) WAS DEPLOYED; HOWEVER, DURING REMOVAL OF THE DELIVERY SYSTEM, THE SECOND AGILE ESOPHAGEAL STENT GOT CAUGHT ON THE DELIVERY CATHETER AND THE STENT WAS REMOVED TOGETHER WITH THE DELIVERY SYSTEM. THE PROCEDURE WAS COMPLETED W

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16136793 ↗
• MalfunctionNov 16, 2022Migration; Migration

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON OCTOBER 28, 2022 THAT AN AGILE ESOPHAGEAL OTW FULLY COVERED STENT WAS IMPLANTED TO TREAT A MALIGNANT ESOPHAGEAL STRICTURE DURING A STENT PLACEMENT PROCEDURE PERFORMED ON AN UNKNOWN DATE. THE PATIENT'S ANATOMY WAS TORTUOUS AND WAS NOT DILATED PRIOR TO STENT PLACEMENT. ON AN UNKNOWN DATE, POST STENT PLACEMENT, IT WAS NOTED THROUGH IMAGING THAT THE AGILE ESOPHAGEAL STENT HAD MIGRATED FROM THE ESOPHAGUS TO THE STOMACH. THE AGILE ESOPHAGEAL STENT REMAINED IMPLANTED AND A WALLFLEX ESOPHAGEAL STENT WAS PLACED TO COMPLETE THE PROCEDURE. REPORTEDLY, THE AGILE ESOPHAGEAL STENT WILL BE SCHEDULED FOR REMOVAL AT A LATER DATE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15809116 ↗