Agile™ Esophageal M00517240Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 08714729972945), received between Nov 24, 2020 and Nov 16, 2023 — classified as 3 injuries.

The most frequently reported specific device problem is “Human-Device Interface Problem” (2 reports).

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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryNov 16, 2023Human-Device Interface Problem; Device Stenosis; Human-Device Interface Problem; Device Stenosis

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN AGILE ESOPHAGEAL PARTIALLY COVERED STENT WAS IMPLANTED IN THE MIDDLE ESOPHAGUS TO TREAT A MALIGNANT STRICTURE DURING A STENT PLACEMENT PROCEDURE PERFORMED ON AN UNKNOWN DATE. THE PATIENT'S ANATOMY WAS TORTUOUS AND WAS NOT DILATED PRIOR TO STENT PLACEMENT. ON OCTOBER 27, 2023, DURING A ROUTINE FOLLOW-UP, IT WAS OBSERVED THAT THERE WAS AN INGROWTH ON THE UNCOVERED PART OF THE STENT. THE PHYSICIAN NOTICED THAT THE STENT INGROWTH OCCURRED MUCH EARLIER THAN WITH THE WALLFLEX ESOPHAGEAL STENT. SUBSEQUENTLY, TO RESTORE PATENCY, A WALLFLEX ESOPHAGEAL STENT WAS PLACED, AND THE PROCEDURE WAS COMPLETED. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. ADDITIONAL INFORMATION RECEIVED ON JANUARY 05, 2024. NOTE: THIS REPORT PERTAINS TO ONE OF TWO DEVICES USED DURING THE SAME PROCEDURE. REFER TO MANUFACTURER REPORTS # 3005099803-2023-06204 AND 3005099803-2024-00099 FOR THE ASSOCIATED DEVICE INFORMATION. ON (B)(6) 2023, THE FIRST AGILE ESOPHAGEAL STENT WAS IMPLANTED (THE SUBJECT OF MFR. REPORT # 3005099803-2024-00099); HOWEVER, ON AN UNKNOWN DATE, THE PATIENT PRESENTED WITH DYSPHAGIA WHICH PROMPTED THE PHYSICIAN TO CHE

  Patient problems: Dysphagia/ Odynophagia; No Clinical Signs, Symptoms or Conditions

  MAUDE report 18155469 ↗
• InjuryFeb 24, 2023Wrong Label; Wrong Label

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON FEBRUARY 02, 2023 THAT AN AGILE ESOPHAGEAL PARTIALLY COVERED STENT WAS TO BE IMPLANTED TO TREAT A 7CM MALIGNANT STRICTURE IN THE LOWER ESOPHAGUS DURING AN ESOPHAGOGASTRODUODENOSCOPY (EGD) WITH STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2023. THE PATIENT'S ANATOMY WAS NOT TORTUOUS AND WAS NOT DILATED PRIOR TO STENT PLACEMENT. DURING THE PROCEDURE, THE AGILE ESOPHAGEAL STENT WAS SUCCESSFULLY PLACED INSIDE THE PATIENT; HOWEVER, IT WAS NOTICED THAT THE STENT WAS UNABLE TO PROVIDE THE NEEDED COVERAGE. SUBSEQUENTLY, THE AGILE ESOPHAGEAL STENT WAS REMOVED WITH FORCEPS AND THE PROCEDURE WAS RESCHEDULED. UPON CHECKING, A 10MM X 6CM AGILE ESOPHAGEAL STENT WAS INCORRECTLY LABELED AS 18MM X 12.5CM 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 16436213 ↗
• InjuryNov 24, 2020Difficult or Delayed Positioning; Use of Device Problem; Activation, Positioning or Separation Problem; Human-Device Interface Problem; Material Deformation; Positioning Problem; Difficult or Delayed Positioning; Use of Device Problem; Activation, Positioning or Separation Problem; Human-Device Interface Problem; Material Deformation; Positioning Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2020 THAT AN AGILE ESOPHAGEAL PARTIALLY COVERED STENT WAS IMPLANTED BELOW THE CRICOPHARYNGEAL MUSCLE TO TREAT AN ESOPHAGEAL FISTULA. REPORTEDLY, THE PATIENT'S ANATOMY WAS NOT TORTUOUS AND WAS NOT DILATED PRIOR TO STENT PLACEMENT PROCEDURE. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, WHILE ATTEMPTING TO DEPLOY THE STENT, STRONG RESISTANCE WAS ENCOUNTERED. REPORTEDLY, THE DELIVERY SYSTEM WAS IN FULLY DEPLOYED POSITION; HOWEVER, THE STENT WAS PARTIALLY DEPLOYED. REPORTEDLY, THE STENT WAS PARTIALLY DEPLOYED ON THE DELIVERY SYSTEM WHEN IT WAS REMOVED FROM THE PATIENT AND THE STENT WAS THEN RE-CONSTRAINED MANUALLY. THEN THE SCOPE AND STENT WERE RE-INSERTED BACK INTO THE PATIENT AND THE STENT WAS FULLY DEPLOYED. THE PHYSICIAN THEN USED A RAT TOOTH FORCEP TO ADJUST THE STENT INTO THE CORRECT POSITION AND THE PROCEDURE WAS COMPLETED. AFTER THE PROCEDURE, A KINK IN THE DEPLOYMENT CATHETER WAS NOTED. 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.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10898255 ↗