Agile™ Esophageal M00517780Recalls & reported problems
Boston Scientific Corporation · Fully 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
- 1
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00191506006655), received between Jun 6, 2024 and Dec 26, 2024 — classified as 1 injury, 1 malfunction.
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-3292-2024 · Root cause: Process control · Recall details · FDA record ↗
Most reported problems
Device problems
- Migration2
- Use of Device Problem1
Patient problems
- Abdominal Pain1
- Dysphagia/ Odynophagia1
- No Clinical Signs, Symptoms or Conditions1
- Vomiting1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
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 ↗InjuryJun 6, 2024Use of Device Problem; Migration; Use of Device Problem; Migration
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN AGILE ESOPHAGEAL OTW FULLY COVERED STENT WAS IMPLANTED TO TREAT A 1.1CM X 15CM MALIGNANT STENOSIS DURING AN ESOPHAGOGASTRODUODENOSCOPY (EGD) WITH STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2024. POST-STENT PLACEMENT, ON (B)(6) 2024, THE PATIENT PRESENTED TO THE EMERGENCY DEPARTMENT WITH DYSPHAGIA, MIDDLE TO LEFT UPPER ABDOMINAL PAIN, AND VOMITING. IT WAS THEN NOTED THAT THE STENT HAD COMPLETELY MIGRATED PROXIMAL TO THE STOMACH. THE STENT WAS REPOSITIONED AND SUTURED TO SECURE ITS POSITION IN THE ESOPHAGUS. HOWEVER, ON (B)(6) 2024, THE PATIENT RETURNED TO THE EMERGENCY DEPARTMENT WITH THE SAME SYMPTOMS. CONSEQUENTLY, THE STENT WAS REMOVED WITH GRASPERS AND THE PROCEDURE WAS COMPLETED. NOTE: IT WAS REPORTED THAT AN AGILE ESOPHAGEAL OTW FULLY COVERED STENT WAS SUTURED TO SECURE ITS POSITION. PER THE AGILE ESOPHAGEAL 23MM OTW PROJECT E0644, THERE IS SUFFICIENT PUBLISHED EVIDENCE IN THE LITERATURE TO SUPPORT THAT THE USE OF STANDARD CLIPS, ENDOSCOPIC SUTURING, AND OVER-THE-SCOPE CLIPS DECREASES STENT MIGRATION BUT DOES NOT ELIMINATE IT.
Patient problems: Abdominal Pain; Dysphagia/ Odynophagia; Vomiting
MAUDE report 19480735 ↗
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.
How reports and recalls are matched · Editorial policy · Report an error on this page