Agile™ Esophageal M00517720Recalls & 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
- 1
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00191506006594), received between Jun 18, 2024 and Dec 31, 2025 — classified as 1 injury, 1 malfunction.
The most frequently reported specific device problem is “Difficult to Remove” (1 report).
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-3288-2024 · Root cause: Process control · Recall details · FDA record ↗
Most reported problems
Device problems
- Difficult to Remove1
- Positioning Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
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 ↗MalfunctionJun 18, 2024Difficult to Remove; Difficult to Remove
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN AGILE ESOPHAGEAL OTW PARTIALLY COVERED STENT WAS TO BE IMPLANTED TO TREAT ESOPHAGEAL CANCER DURING A STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2024. DURING THE PROCEDURE, AFTER THE GUIDEWIRE WAS INSERTED ACROSS THE STRICTURE AND A PAPERCLIP PLACED ON THE HALFWAY POINT, THE STENT WAS SENT DOWN OVER THE GUIDEWIRE. THE STENT WAS THEN ABLE TO BE DEPLOYED; HOWEVER, UPON REMOVING THE DELIVERY SYSTEM, THE STENT ALONG WITH THE DELIVERY SYSTEM CAME OUT OF 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 19556837 ↗
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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