Agile™ Esophageal M00517250Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 08714729972952), received between Nov 17, 2023 and Sep 17, 2026 — classified as 3 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Device Stenosis” (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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 17, 2026Device Misassembled During Manufacturing /Shipping

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50810488 ↗
• MalfunctionApr 7, 2026Device Markings/Labelling Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN AGILE ESOPHAGEAL TTS PARTIALLY COVERED STENT WAS IMPLANTED ON (B)(6) 2026. DURING THE PROCEDURE, AN AGILE PARTIALLY COVERED STENT WAS DEPLOYED IN THE PATIENT. HOWEVER, BASED ON THE PHYSICIAN ASSESSMENT, THE STENT APPEARED TO BE FULLY COVERED. A MANTIS CLIP WAS USED TO SECURE THE STENT IN CASE OF MIGRATION. THE PHYSICIAN BELIEVES THAT A FULLY COVERED AGILE STENT WAS INCORRECTLY PACKAGED IN A PARTIALLY COVERED AGILE STENT BOX. THE STENT REMAINED IMPLANTED, AND THE PROCEDURE WAS COMPLETED. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24811374 ↗
• InjurySep 18, 2024Migration; Migration

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN AGILE ESOPHAGEAL PARTIALLY COVERED STENT TTS WAS IMPLANTED IN THE GASTROESOPHAGEAL SPHINCTER TO TREAT A STRICTURE DURING A THERAPEUTIC GASTROSCOPY PROCEDURE PERFORMED ON (B)(6) 2024. THE PATIENTS ANATOMY WAS NOT TORTUOUS AND NOT DILATED PRIOR TO STENT PLACEMENT. TEN DAYS POST STENT PLACEMENT, THE PATIENT EXPERIENCED SEVERE VOMITING THAT LIKELY CAUSED THE STENT TO MIGRATE PROXIMALLY. THE STENT WAS ULTIMATELY COUGHED OUT AND EXPELLED THROUGH THE MOUTH. ACCORDING TO THE PHYSICIAN, THE STENT WAS TOO SMALL FOR THE PATIENT'S ANATOMY. THERE HAS BEEN NO NEW STENT IMPLANTED, BUT THE PHYSICIAN PLANS TO IMPLANT ANOTHER STENT WITH A LARGER DIAMETER SIZE TO ADDRESS THE PATIENT'S STRICTURE WHILE REDUCING MIGRATION RISK. THE PATIENT CONDITION WAS REPORTED TO BE DETERIORATING.

  Patient problems: Vomiting

  MAUDE report 20245791 ↗
• MalfunctionApr 5, 2024Activation Failure; Activation Failure

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN AGILE ESOPHAGEAL PARTIALLY COVERED STENT WAS TO BE IMPLANTED IN THE ESOPHAGUS DURING A PROCEDURE PERFORMED ON AN UNKNOWN DATE. DURING THE PROCEDURE, THE STENT WAS DEPLOYED INSIDE THE PATIENT BUT COULD NOT EXPAND COMPLETELY. THE PROCEDURE WAS COMPLETED WITH ANOTHER AGILE ESOPHAGEAL STENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT, AND THE PATIENT'S CONDITION AFTER THE PROCEDURE WAS REPORTED TO BE STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19056186 ↗
• InjuryFeb 1, 2024Human-Device Interface Problem; Device Stenosis; Human-Device Interface Problem; Device Stenosis

  NOTE: THIS REPORT PERTAINS TO ONE OF TWO DEVICES USED DURING THE SAME PROCEDURE. REFER TO MANUFACTURER REPORTS # 3005099803-2023-06204 FOR THE ASSOCIATED DEVICE INFORMATION. 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 (B)(6) 2023. THE PATIENT'S ANATOMY WAS TORTUOUS. POST STENT PLACEMENT, ON AN UNKNOWN DATE, THE PATIENT PRESENTED WITH DYSPHAGIA WHICH PROMPTED THE PHYSICIAN TO CHECK THE STENT (THE SUBJECT OF THIS REPORT). STENT INGROWTH WAS OBSERVED AND A SECOND AGILE ESOPHAGEAL STENT (THE SUBJECT OF MFR. REPORT # 3005099803-2023-06204) WAS PLACED ON (B)(6) 2023. PRIOR TO STENT PLACEMENT, THE PATIENT'S ANATOMY WAS NOT DILATED. SUBSEQUENTLY, ON AN UNKNOWN DATE, THE PATIENT PRESENTED AGAIN WITH DYSPHAGIA. THE STENT WAS CHECKED AND STENT INGROWTH WAS ALSO OBSERVED. THE PHYSICIAN NOTICED THAT THE STENT INGROWTH OCCURRED MUCH EARLIER THAN WITH THE WALLFLEX ESOPHAGEAL STENT. TO RESTORE PATENCY, A WALLFLEX ESOPHAGEAL STENT WAS PLACED, AND THE PROCEDURE WAS COMPLETED.

  Patient problems: Dysphagia/ Odynophagia

  MAUDE report 18627523 ↗
• InjuryNov 17, 2023Human-Device Interface Problem; Device Stenosis; Human-Device Interface Problem; Device Stenosis

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN AGILE ESOPHAGEAL 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. ON AN UNKNOWN DATE, POST STENT PLACEMENT, 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, ANOTHER STENT WAS PLACED AND THE PROCEDURE WAS COMPLETED. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. ON AN UNKNOWN DATE, POST STENT PLACEMENT, THE PATIENT PRESENTED WITH DYSPHAGIA WHICH PROMPTED THE PHYSICIAN TO CHECK THE STENT. A WALLFLEX ESOPHAGEAL STENT WAS PLACED TO COMPLETE THE PROCEDURE. THE AGILE ESOPHAGEAL STENT REMAINED IMPLANTED.

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

  MAUDE report 18161034 ↗