Agile EsophagealRecalls & reported problems across all models

We found 16 models of Agile Esophageal by Boston Scientific Corporation in the FDA's device registry (GUDID). Together they are named in 66 adverse event reports in the FDA's MAUDE database, received between Nov 24, 2020 and Sep 17, 2026 — classified as 3 deaths, 34 injuries, 29 malfunctions.

The most frequently reported specific device problem is “Migration” (24 reports).

6 FDA recall records name at least one of these models by its device identifier, 6 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Agile Esophageal recalls

FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.

1. Aug 1, 2024Open, Classified

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

   Z-3292-2024 · Root cause: Process control · Recall details · FDA record ↗

2. Aug 1, 2024Open, 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 ↗

3. Aug 1, 2024Open, Classified

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

   Z-3290-2024 · Root cause: Process control · Recall details · FDA record ↗

4. Aug 1, 2024Open, Classified

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

   Z-3289-2024 · Root cause: Process control · Recall details · FDA record ↗

5. Aug 1, 2024Open, Classified

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

   Z-3288-2024 · Root cause: Process control · Recall details · FDA record ↗

6. Aug 1, 2024Open, Classified

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

   Z-3287-2024 · Root cause: Process control · Recall details · FDA record ↗

Most reported Agile Esophageal problems

Agile Esophageal models

16 models, most reported first. Each model has its own page with its reports, recalls and device details.

• Agile™ Esophageal M00517760

  PROSTHESIS, ESOPHAGEAL
  1 recall10 reports
• Agile™ Esophageal M00517720

  PROSTHESIS, ESOPHAGEAL
  1 recall2 reports
• Agile™ Esophageal M00517730

  PROSTHESIS, ESOPHAGEAL
  1 recall2 reports
• Agile™ Esophageal M00517780

  PROSTHESIS, ESOPHAGEAL
  1 recall2 reports
• Agile™ Esophageal M00517710

  PROSTHESIS, ESOPHAGEAL
  1 recall1 report
• Agile™ Esophageal M00517740

  PROSTHESIS, ESOPHAGEAL
  1 recall1 report
• Agile™ Esophageal M00517770

  PROSTHESIS, ESOPHAGEAL
  11 reports
• Agile™ Esophageal M00517450

  PROSTHESIS, ESOPHAGEAL
  2 deaths7 reports
• Agile™ Esophageal M00517250

  PROSTHESIS, ESOPHAGEAL
  6 reports
• Agile™ Esophageal M00517460

  PROSTHESIS, ESOPHAGEAL
  6 reports
• Agile™ Esophageal M00517400

  PROSTHESIS, ESOPHAGEAL
  4 reports
• Agile™ Esophageal M00517440

  PROSTHESIS, ESOPHAGEAL
  1 death4 reports
• Agile™ Esophageal M00517240

  PROSTHESIS, ESOPHAGEAL
  3 reports
• Agile™ Esophageal M00517470

  PROSTHESIS, ESOPHAGEAL
  3 reports
• Agile™ Esophageal M00517260

  PROSTHESIS, ESOPHAGEAL
  2 reports
• Agile™ Esophageal M00517270

  PROSTHESIS, ESOPHAGEAL
  2 reports

Recent Agile Esophageal adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionSep 17, 2026Device Misassembled During Manufacturing /Shipping

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50810488 ↗
• MalfunctionAug 19, 2026Device-Device Incompatibility; Positioning Problem

  Note: This report pertains to an Agile Esophageal Stent and Overstitch NXT used during the same procedure.It was reported to Boston Scientific Corporation that an Agile Esophageal Fully Covered TTS stent was attempted to be implanted during an Esophagogastroduodenoscopy (EGD) procedure performed on (b)(6) 2026. During the procedure, the Agile stent was successfully placed; however, during scope removal, the stent became caught on the OverStitch needle driver and had to be forcibly removed. The procedure was completed using another Agile Esophageal TTS stent. There were no patient complications associated with this event and the patient condition following the procedure was reported as stable.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50334618 ↗
• 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 ↗
• InjuryJun 11, 2026Use of Device Problem; Migration

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN AGILE ESOPHAGEAL OTW STENT WAS IMPLANTED TO TREAT DISTAL ESOPHAGEAL CANCER DURING AN ESOPHAGOGASTRODUODENOSCOPY (EGD) WITH STENT PLACEMENT ON (B)(6) 2026. IT WAS REPORTED THAT THE STENT WAS SUCCESSFULLY DEPLOYED BUT MIGRATED APPROXIMATELY TWO WEEKS AFTER IMPLANTATION. THE PATIENT EXPERIENCED DISCOMFORT DUE TO PAIN. THE MIGRATED STENT WAS REMOVED USING RESCUE FORCEPS, AND A LONGER AGILE ESOPHAGEAL OTW STENT WAS PLACED TO COMPLETE THE PROCEDURE.

  Patient problems: Pain

  MAUDE report 25474163 ↗
• MalfunctionApr 7, 2026Device Markings/Labelling Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN AGILE ESOPHAGEAL TTS PARTIALLY COVERED STENT WAS IMPLANTED ON (B)(6) 2026. DURING THE PROCEDURE, AN AGILE PARTIALLY COVERED STENT WAS DEPLOYED IN THE PATIENT. HOWEVER, BASED ON THE PHYSICIAN ASSESSMENT, THE STENT APPEARED TO BE FULLY COVERED. A MANTIS CLIP WAS USED TO SECURE THE STENT IN CASE OF MIGRATION. THE PHYSICIAN BELIEVES THAT A FULLY COVERED AGILE STENT WAS INCORRECTLY PACKAGED IN A PARTIALLY COVERED AGILE STENT BOX. THE STENT REMAINED IMPLANTED, AND THE PROCEDURE WAS COMPLETED. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24811374 ↗
• InjuryDec 31, 2025Positioning Problem; Positioning Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN AGILE ESOPHAGEAL PARTIALLY COVERED STENT WAS TO BE IMPLANTED IN THE ESOPHAGUS TO TREAT ESOPHAGEAL CANCER DURING AN ESOPHAGOGASTRODUODENOSCOPY (EGD) PROCEDURE PERFORMED ON DECEMBER 1, 2025. THE PATIENT'S ANATOMY WAS TORTUOUS (TIGHT) AND WAS NOT DILATED PRIOR TO STENT PLACEMENT. DURING THE PROCEDURE, IT WAS REPORTED THAT THE PHYSICIAN WAS NOT PLEASED WITH THE PLACEMENT OF THE 10CM AGILE ESOPHAGEAL STENT AS IT "JUMPED" FORWARD UPON PLACEMENT AND WAS NOT ABLE TO REPOSITION CORRECTLY. THE STENT WAS THEN REMOVED WITH RAT TOOTH FORCEPS. THE PROCEDURE WAS COMPLETED WITH ANOTHER STENT OF THE SAME MODEL BUT WITH A LONGER SIZE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23935704 ↗
• 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 ↗
• 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 ↗
• 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 ↗
• InjuryJan 30, 2025Migration; Migration

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN AGILE ESOPHAGEAL FULLY COVERED STENT TTS WAS IMPLANTED IN THE ESOPHAGUS TO TREAT AN ESOPHAGEAL STRICTURE DURING AN ESOPHAGOGASTRODUODENOSCOPY (EGD) WITH STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2024. DURING THE PROCEDURE, THE STENT WAS SUCCESSFULLY DEPLOYED. THE PATIENT UNDERWENT THERAPY, AND IT WAS NOTED THAT THE STENT HAD MIGRATED. ANOTHER WALLFLEX STENT WAS PLACED, AND THE PHYSICIAN PLANS TO REMOVE THE MIGRATED STENT IN APPROXIMATELY 3 WEEKS. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21280068 ↗
• 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 ↗
• MalfunctionDec 26, 2024Migration; Migration

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN AGILE ESOPHAGEAL OVER-THE-WIRE STENT WAS IMPLANTED IN THE ESOPHAGUS TO TREAT A MALIGNANT-APPEARING, INTRINSIC, MODERATE ULCERATED STENOSIS DURING AN ESOPHAGOGASTRODUODENOSCOPY (EGD) PROCEDURE PERFORMED ON (B)(6) 2024. ON (B)(6) 2024, COMPLETE PROXIMAL STENT MIGRATION OCCURRED. REPORTEDLY, THE STRICTURE WAS NOT RESOLVED. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21020784 ↗

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