Agile™ Esophageal M00517730Recalls & reported problems
Boston Scientific Corporation · Partially Covered OTW Stent System · Class 2 · Implant
All models of Agile Esophageal (16)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00191506006600), received between Sep 30, 2024 and Jun 11, 2026 — classified as 2 injuries.
The most frequently reported specific device problem is “Migration” (2 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.
Reports received per month
Recalls naming this device
- 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-3289-2024 · Root cause: Process control · Recall details · FDA record ↗
Most reported problems
Device problems
- Migration2
- Activation Failure1
- Use of Device Problem1
Patient problems
- Insufficient Information1
- Pain1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
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 ↗InjurySep 30, 2024Activation Failure; Migration; Activation Failure; Migration
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN AGILE ESOPHAGEAL PARTIALLY COVERED OTW STENT WAS IMPLANTED TO TREAT AN ESOPHAGEAL CANCER DURING A STENT PLACEMENT PROCEDURE PERFORMED ON AN (B)(6) 2024. DURING THE PROCEDURE, THE STENT WAS ABLE TO BE DEPLOYED. HOWEVER, POST STENT PLACEMENT, CHEST XRAY REVEALED THAT THE STENT HAD NOT FULLY EXPANDED. THE PATIENT WAS NOT DOING WELL AND WAS BROUGHT BACK FOR EMERGENT FOLLOW UP. UNDER ENDOSCOPIC VISUALIZATION, IT WAS NOTED THAT THE STENT HAD MIGRATED AND DID NOT EXPAND. THE PHYSICIAN THEN USED A RETRIEVAL LOOP TO PULL THE STENT 5CM UP TOWARDS THE MOUTH. THE STENT REMAINS IMPLANTED, AND THE PHYSICIAN SCHEDULED A REMOVAL OR REVISION OF THE STENT ON (B)(6) 2024. A WALLFLEX PARTIALLY COVERED ESOPHAGEAL STENT IS SCHEDULED TO BE PLACED.
Patient problems: Insufficient Information
MAUDE report 20335992 ↗
Other PROSTHESIS, ESOPHAGEAL devices
- WallFlex™ Esophageal M00516730Boston Scientific Corporation · PROSTHESIS, ESOPHAGEAL1 recall29 reports
- WallFlex™ Esophageal M00516740Boston Scientific Corporation · PROSTHESIS, ESOPHAGEAL1 recall1 death22 reports
- WallFlex™ Esophageal M00516750Boston Scientific Corporation · PROSTHESIS, ESOPHAGEAL1 recall1 death19 reports
- WallFlex™ Esophageal M00516700Boston Scientific Corporation · PROSTHESIS, ESOPHAGEAL1 recall18 reports
- WallFlex™ Esophageal M00516910Boston Scientific Corporation · PROSTHESIS, ESOPHAGEAL1 recall15 reports
- WallFlex™ Esophageal M00516930Boston Scientific Corporation · PROSTHESIS, ESOPHAGEAL1 recall14 reports
- WallFlex™ Esophageal M00516710Boston Scientific Corporation · PROSTHESIS, ESOPHAGEAL1 recall13 reports
- WallFlex™ Esophageal M00516940Boston Scientific Corporation · PROSTHESIS, ESOPHAGEAL1 recall12 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026 · each recall links to the FDA recall notice
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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