Agile™ Esophageal M00517740Recalls & 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
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00191506006617), received between May 31, 2022 and May 31, 2022 — classified as 1 injury.
The most frequently reported specific device problem is “Material Integrity Problem” (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.
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-3290-2024 · Root cause: Process control · Recall details · FDA record ↗
Most reported problems
Device problems
- Material Integrity Problem1
- Positioning Problem1
- Use of Device Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryMay 31, 2022Use of Device Problem; Material Integrity Problem; Positioning Problem; Use of Device Problem; Material Integrity Problem; Positioning Problem
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON APRIL 15, 2022 THAT AN AGILE ESOPHAGEAL OTW STENT WAS IMPLANTED TO TREAT A 5 CM MALIGNANT ESOPHAGEAL STRICTURE IN THE LOWER PORTION OF THE ESOPHAGUS DURING A PROCEDURE PERFORMED ON (B)(6) 2022. DURING THE PROCEDURE, THE PHYSICIAN WAS HAVING DIFFICULTY SEEING THE STENT UNDER FLUOROSCOPIC VIEW BUT CONTINUED WITH DEPLOYMENT. AFTER THE STENT WAS DEPLOYED, IT WAS NOTED TO HAVE BEEN PLACED IN AN INCORRECT LOCATION. THE STENT WAS REMOVED FROM THE PATIENT WITH FORCEPS AND THE PROCEDURE WAS COMPLETED WITH A WALLFLEX ESOPHAGEAL STENT. 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 FINE. NOTE: THE PHYSICIAN STATED HE DID NOT USE THE RX MARKERS ON THE DELIVERY SYSTEM WHEN PLACING THE AGILE STENT, INSTEAD HE USED THE CONSTRAINED STENT ITSELF. HE IS USED TO THE VISIBILITY OF THE WALLFLEX STENT UNDER FLUOROSCOPY, SO WITH THE AGILE WIRES BEING THINNER THEY WERE LESS VISIBLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14546945 ↗
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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