Agile™ Esophageal M00517270Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 08714729972976), received between Jul 25, 2022 and Sep 16, 2024 — classified as 2 injuries.

The most frequently reported specific device problem is “Difficult or Delayed Positioning” (1 report).

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.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjurySep 16, 2024Difficult or Delayed Positioning; Positioning Problem; Difficult or Delayed Positioning; Positioning Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN AGILE ESOPHAGEAL TTS PARTIALLY COVERED STENT WAS IMPLANTED IN THE DISTAL OESOPHAGUS TO TREAT A 6CM DISTAL TUMOR DUE TO OESOPHAGEAL CANCER DURING A GASTROSCOPY WITH STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2024. THE PATIENT'S ANATOMY WAS NOT TORTUOUS AND WAS NOT DILATED PRIOR TO STENT PLACEMENT. DURING THE PROCEDURE, THERE WAS DIFFICULTY ENCOUNTERED WHEN DEPLOYING THE STENT. THE STENT EVENTUALLY FULLY DEPLOYED; HOWEVER, THE STENT SLIGHTLY MOVED OUT OF ITS POSITION PROXIMALLY. THE PHYSICIAN ATTEMPTED TO REPOSITION THE STENT USING GRASPING FORCEPS BUT WAS UNSUCCESSFUL. THE STENT REMAINS IMPLANTED, AND THE PHYSICIAN IS COMFORTABLE LEAVING THE STENT IN PLACE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20226713 ↗
• InjuryJul 25, 2022Migration; Migration

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2022 THAT AN AGILE ESOPHAGEAL STENT WAS IMPLANTED TO TREAT A 3 CM MALIGNANT TRACHEOESOPHAGEAL FISTULA DURING AN ESOPHAGEAL STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2022. THE PATIENT'S ANATOMY WAS NOT TORTUOUS AND WAS NOT DILATED PRIOR TO STENT PLACEMENT. TWO DAYS POST STENT PLACEMENT, IMAGING WAS PERFORMED AND IT WAS NOTED THAT THE AGILE ESOPHAGEAL STENT HAD COMPLETELY MIGRATED. THE AGILE ESOPHAGEAL STENT WAS REMOVED FROM THE PATIENT AND A DIFFERENT DEVICE WAS IMPLANTED 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 15096542 ↗