Agile™ Esophageal M00517260Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 08714729972969), received between Aug 22, 2024 and Nov 18, 2024 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Activation, Positioning or Separation Problem” (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.

• MalfunctionNov 18, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN AGILE ESOPHAGEAL PARTIALLY COVERED STENT WAS IMPLANTED IN THE ESOPHAGUS DURING A STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2024. DURING THE PROCEDURE, AFTER THE STENT WAS DEPLOYED, IT WAS NOTED THAT THE TIP OF THE DELIVERY SYSTEM WAS DETACHED AND REMAINED INSIDE THE PATIENT. NO ATTEMPT WAS MADE TO RETRIEVE THE TIP BECAUSE THE STENT COULD BE DISLODGED, WHICH WAS POSITIONED HIGH IN THE ESOPHAGUS. THE STENT REMAINED IMPLANTED, AND THE PROCEDURE WAS COMPLETED. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. NOTE: NO FURTHER INFORMATION HAS BEEN OBTAINED DESPITE GOOD FAITH EFFORTS.

  Patient problems: Foreign Body In Patient

  MAUDE report 20716521 ↗
• MalfunctionAug 22, 2024Break; Activation, Positioning or Separation Problem; Break; Activation, Positioning or Separation Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN AGILE ESOPHAGEAL PARTIALLY COVERED STENT WAS TO BE IMPLANTED IN THE DISTAL PART OF THE ESOPHAGUS, ACROSS CARDIAS, TO TREAT A MALIGNANT STENOSIS DURING AN ESOPHAGOGASTRODUODENOSCOPY (EGD) PROCEDURE PERFORMED ON (B)(6) 2024. THE PATIENT'S ANATOMY WAS TORTUOUS AND WAS NOT DILATED PRIOR TO STENT PLACEMENT. DURING THE PROCEDURE, THE STENT WAS ABLE TO CROSS THE ANATOMY. HOWEVER, THE HANDLE WAS VERY HARD DURING AN ATTEMPTED STENT DEPLOYMENT, AND THE HANDLE GOT BROKEN. THE STENT WAS REMOVED PARTIALLY DEPLOYED ON THE DELIVERY SYSTEM, AND A DIFFERENT DEVICE WAS USED 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 20028662 ↗